•  Prisons ‘Failing’ on HIV and Hepatitis C

•  Bristol-Myers Posts Baraclude Data

•  Hepatitis C Transmission: More on the Link with Drugs and Unprotected Sex

•  Human Genome Sciences Reports Interim Results of Phase 2 Clinical Trial of Albuferon(TM) in Combination with Ribavirin in Treatment-Experienced Hepatitis C Patients

•  Teacher Claims She Got Hepatitis on Job

•  Legal Move in Hep C Blood Battle

•  Idenix Hepatitis C Pill Shows Promises in Trial

•  Hepatitis C Patients Fare Better with Pegasys(R) - Study from Poland Shows Significant Difference in Efficacy between Leading Treatments

•  SciClone Announces Data Presentations at AASLD Regarding ZADAXIN's Activity in Hepatitis B

•  Hep C Victims' Families Seek Public Inquiry

•  Xtlbio's Hepatitis C Drug Candidate Succeeds in Trial

•  Health Officials Raise Hepatitis C Awareness

•  Sertraline (Zoloft) Relieves Pruritus in Cholestatic Liver Disease: Presented at AASLD

•  Caught in Pot Debate -- Hepatitis C Patient Wants His Medical Marijuana Back from Police

•  Blues in C -- Raising Awareness of Hepatitis C

•  Health Alert: Hepatitis C

•  Memorandum of Understanding Marks Progress in Hepatitis C Compensation Discussions

•  Transmission of Hepatitis C Through Swapping Body Jewelry

•  Hepatitis C Combination Therapies in Pill Form Move Nearer

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November 7^th, 2005


Correction: Peregrine Pharmaceuticals Evaluating Therapeutic Opportunities for Tarvacin(TM) against Influenza Viruses Including Avian Flu
SourceURL:http://ir.peregrineinc.com

(This was previously posted in the News Review for the Week of October 24th, 2005 as “Peregrine Pharma ( PPHM ) is testing Novel anti-viral as a combo-therapy with Tamiflu. Additionally, The Government is Testing Peregrine Pharma (PPHM) as a Mono therapy for LL ENVELOPED VIRUSES INCLUDING BIRD FLU.” There is no “combo-therapy” – ed.)

- Company Provides Review of Tarvacin Anti-Viral Program for Influenza, Including Collaborations with Federal Agencies, Academic Research Centers and Private Research Organizations -

TUSTIN, Calif., Oct. 24 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM) at its Annual Meeting of Stockholders today will provide a review of its ongoing programs to evaluate its unique anti-phospholipid agent Tarvacin(TM) Anti-Viral for the treatment of influenza. Peregrine is actively collaborating with the National Institutes of Allergy and Infectious Diseases (NIAID) to assess Tarvacin Anti-Viral in preclinical flu models, and the company is also working directly with academic research centers and private research organizations to evaluate Tarvacin as a stand-alone agent and in combination with existing influenza therapies. In addition, Peregrine has entered into discussions with other federal officials to evaluate the potential of Tarvacin to treat influenza, including avian flu. Tarvacin Anti-Viral is currently in a Phase I clinical trial for the treatment of chronic hepatitis C virus infections.

Tarvacin is a monoclonal antibody that attaches to phospholipids, specific cellular components that are exposed on the outer surface of all enveloped viruses tested to date including influenza, as well as on the human host cells that are infected with these viruses. Enveloped viruses, which have a coating derived from their host's cell membrane, are responsible for about half of all human viral diseases. Tarvacin Anti-Viral has been shown to protect animals from lethal infections in two preclinical models of enveloped viruses -- cytomegalovirus and pichinde virus, a model for the deadly Lassa hemorrhagic fever. Peregrine has previously reported that Tarvacin Anti-Viral binds to members of six different virus families, including influenza A and B, HIV 1 and 2, measles, respiratory syncytial virus and pichinde virus. Recent studies confirmed that Tarvacin Anti-Viral binds to human cells infected with influenza A.

"Evaluating Tarvacin Anti-Viral as a potential treatment for influenza, including deadly new strains such as avian flu, is a high priority for the company," said Steven King, president and CEO of Peregrine. "Given current global concerns about the possibility of an avian flu pandemic, we are rapidly identifying and assessing a number of opportunities to ramp up our existing collaborations with public and private sector partners to further accelerate these studies."

The specific phospholipids targeted by Tarvacin Anti-Viral come from the human host and are incorporated into the envelop the virus acquires as it leaves the host's cells to propagate and spread the viral infection. Unlike drugs that target an attribute of the virus, Tarvacin's host-derived phospholipid target is expected to be less susceptible to the development of drug resistance, since the virus cannot simply mutate to avoid Tarvacin's anti-viral effects.

"The unique mechanism of action and stable nature of the target could make Tarvacin Anti-Viral a particularly attractive clinical candidate for the treatment of influenza, either as a stand-alone agent or in combination with existing therapies," said Joseph Shan, senior director of clinical and regulatory affairs at Peregrine. "We are accelerating our joint efforts with a number of public and private organizations to more fully evaluate the anti-influenza potential of Tarvacin Anti-Viral. If these preclinical studies produce positive results, we plan to expand our activities to expedite the initiation of human clinical trials."

Tarvacin also binds to phospholipids exposed on tumor blood vessels in all solid cancers tested to date, and it has shown promise in a number of preclinical cancer studies. Tarvacin Anti-Cancer is currently in a multi-center Phase I clinical trial for patients with advanced refractory solid tumors.

About Peregrine
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative product candidates in clinical trials for the treatment of cancer and viral diseases. The company is pursuing three separate clinical trials in cancer and anti-viral indications with its lead product candidates Tarvacin(TM) and Cotara(R). Peregrine also has in-house manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. (http://www.avidbio.com), which provides development and bio-manufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at http://www.peregrineinc.com.

Safe Harbor Statement:
Statements in this press release which are not purely historical, including statements regarding Peregrine Pharmaceutical's intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements involve risks and uncertainties including, but not limited to, the risk that Tarvacin Anti-Viral's results regarding it's ability to stop the spread of viral infection from infected cells to nearby healthy cells and to protect animals from lethal infections in a variety of preclinical models of enveloped viruses will not be consistent in human testing and the uncertainties that safety and efficacy studies in the Phase I clinical study may not correlate to safety and efficacy data from the pre-clinical animal models. It is important to note that the company's actual results could differ materially from those in any such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, the timing to enroll patients in this clinical study or any study the Company is conducting and the uncertainty of clinical trial results in this study or any clinical study. Our business could be affected by all of the foregoing and a number of other factors, including the risk factors listed from time to time in the Company's SEC reports including, but not limited to, the annual report on Form 10-K for the year ended April 30, 2005. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Peregrine Pharmaceuticals, Inc. disclaims any obligation, and does not undertake, to update or revise any forward-looking statements in this press release.

SOURCE Peregrine Pharmaceuticals, Inc.
10/24/2005

CONTACT: Investors: Barbara Lindheim, 1-800-987-8256, ir@peregrineinc.com, Media: Stephen Gendel, +1-212-918-4650, both of GendeLLindheim BioCom Partners

Web site: http://www.peregrineinc.com
http://www.avidbio.com

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November 13th, 2005


A Past of 'Rich Things,' and a Harrowing Present
SourceURL:http://www.boston.com
By Don Lee

Veronica
By Mary Gaitskill
Pantheon, 227 pp., $23

Readers unfamiliar with Mary Gaitskill need only, perhaps, look at the titles of her three previous books to get an inkling of her preoccupations: her story collections ''Bad Behavior" and ''Because They Wanted To," and her first novel, ''Two Girls, Fat and Thin." A further clue is that one of her short stories was adapted into the indie film ''Secretary," a piquant little romance involving sadomasochism. Indeed, those books established Gaitskill as a literary provocateur, a queen of squirmy perversion. Strippers, hookers, runaways, junkies, punks, dirty old men -- Gaitskill used them to explore the urban gutter of sexual power games and abuse. Not always a pretty picture, but not one given purely for prurient effect. The stories artfully walked the wild side in order to reveal a yearning for intimacy beneath the surface pathologies.

In her new novel, ''Veronica," coming after an eight-year absence, Gaitskill dutifully dips into her catalog of outré details. There is sex and depravity aplenty, along with the requisite scatological references. There's even a visit to an S&M club. Yet there is something much more in this novel. The kinky pyrotechnics have been toned down in favor of a wiser, more meditative perspective. Gaitskill taps into a deeper vein of emotional force, and with vivid language and an absorbing architecture, she delivers her most affecting, sophisticated work to date.

In the simplest terms, ''Veronica" is about one day in the life of the narrator, Alison Owen. Forty-six years old, living in San Rafael, Calif., she is destitute and ill. Already on disability with a mangled rotator cuff, in the past year she has become beset with symptoms of hepatitis C. She can't sleep, racked by dreams, and needs fistfuls of codeine to make it through the day. On this rainy morning, she begins thinking about a friend, Veronica Ross, from her long-ago time in New York. They had been unlikely companions, Alison 21 and beautiful then, Veronica 37, plump, loud, a rather appalling sight with her bad makeup and clothes. They had met when Alison, in a fallow period in her modeling career, was temping at an ad agency where Veronica worked as a proofreader. She would eventually die alone of AIDS, ''ugly and sick." Now that Alison is confronting her own mortality, her face ''ruined . . . broken, with age and pain coming through the cracks," she is visited by memories -- not only of Veronica, but of her childhood and modeling days in Paris and New York during the reckless excess of the 1980s.

Particularly in the first half of the novel, Gaitskill shows a bravura technical virtuosity in interweaving these competing narratives, mirroring the ricochets of Alison's addled mind. Alison might feel that her focus is slipping, wherein ''the order of things is changed" and ''the people and places in it are sliding around indiscriminately," yet the reader never feels displaced, and is pulled along by the mystery of how she gets here from there, from growing up in New Jersey to running away to San Francisco to modeling in Paris, where she is immediately swept up by the fast life. Alison becomes the mistress of the head of her modeling agency, Alain, who ensconces her in an opulent apartment stocked with cocaine, marzipan, and syringes of antibiotics for the clap. ''I loved the rich things and the money and people kissing my ass," Alison admits. ''I loved the song I was living in." Ultimately, however, she is exploited and disgraced, and is forced to return to New Jersey.

To Gaitskill's credit, Alison's family home isn't depicted as a clichéd den of maltreatment and dysfunction. It's more complicated than that, and more real, her mother, father, and two sisters all suffering from vague discontents, feeling they are being crushed by a dull world. It's the same kind of restlessness that led Alison to leave in the first place, ''longing to live inside a world described by music," a world in which there are ''no deep things, no vulgar goodwill, only rigorous form and beauty." Trying to settle into an ordinary existence, she goes to community college, studies word-processing, and applies for secretarial positions, but eventually resumes modeling, seduced by the parties, the clubs, the fame. It all comes to a quick end, of course -- ''Honey, your look is dead," a booker pronounces when she is 25 -- and as it does, Alison becomes closer to Veronica. Although she often regards her with disgust, Alison is drawn to the older woman out of curiosity and, when Veronica contracts HIV from her bisexual boyfriend, out of pity.

Here the novel comes up a bit short. The friendship, with its complex dynamic, isn't filled in with the sustained narrative or scenes it deserves, and the same could be said of the depiction of Alison's current life. The intent might have been to parallel the way her past subsumes her present, yet, compared with the vibrant sections in the first half, the second half peters out disappointingly, reduced to one-paragraph fragments that describe her feverishly climbing a hill in a lush canyon preserve -- too meager, not to mention too obvious a symbol.

What does come through fully, though, is Alison herself. Despite all the confessions of her ''vanities" and ''passive cruelties," we end up caring for her as she tries to reconcile her life and salvage some hard-won beauty and humanity. She is alone, but she reflects, ''It did not feel bad. It felt like something hidden was slowly becoming visible."

Don Lee is the author of ''Country of Origin," which won an American Book Award.

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Needing Livers, Needing Answers
SourceURL:http://www.latimes.com
By Megan Garvey, Times Staff Writer

UCI Medical Center patients, many waiting years for a transplant, are jolted by news that the hospital has rejected possibly suitable organs.

When they placed him on their waiting list for a new liver more than five years ago, UC Irvine Medical Center officials warned Wayne Beeman that his chance for a transplant could come with a moment's notice.

"They said it could happen real quickly --have your stuff packed and ready to go," he said.

He's had a bag waiting at his Fullerton home ever since.

Each morning, Beeman -- who finds a flight of stairs exhausting and worries that life-threatening complications could hit at any time -- clips on the pager officials gave him, loath to miss a potentially life-saving call.

On Thursday, he got another sort of call, one he never expected. It was the leader of one of his support groups, asking if he had heard the news: The UC Irvine program Beeman had counted on was closing.

As soon as he heard, Beeman, 59, a soft-spoken former school psychologist whose main hobby is singing in his church choir, sought counseling from a minister.

"I've been sitting in the foxhole now for five years," he said, "waiting for the cavalry to come to the rescue-- It's kind of like nobody showed up."

UCI's 12-year-old liver transplant program was disbanded Thursday amid revelations that it had refused inordinate numbers of livers offered for its patients. While UCI patients continued to die on the waiting list and others were added, many of the supposedly unsuitable organs were accepted by other liver centers and transplanted into their patients.

Interviews and documents obtained by The Times showed that UCI had not employed a full-time liver transplant surgeon for more than a year, and that the staffing shortage and other troubles dated back at least four years.

The program closed with 106 patients still waiting for new livers -- two of whom were hospitalized at UC Irvine's medical center in Orange.

One of those patients was moved to UC San Diego on Friday to await a liver; the other is being medically stabilized before transfer to another center, according to hospital Chief Executive Ralph Cygan.

Many of the rest, like Beeman, must also find a new medical center willing to take them. Since UCI had the only liver transplant program in Orange County, they now may face longer commutes for medical care -- a significant obstacle for seriously ill patients who may require weekly or even daily care.

News of the scandal and closure has left patients and their families reeling.

Donna Wills, 62, said she's been "numb" ever since her husband called her to the television late last week for a news report on UCI's woes. Don Wills, 64, had been waiting for a transplant at UCI since June 2002.

"I just felt like people put a hole in the middle of the Earth and we were dropped off," she said.

She takes little solace from the fact that her husband already is on the waiting list at UC San Diego, a move they made last year on the advice of one of his UCI doctors. How much time did he waste, she wonders, waiting for UCI to come through?

"It's hard," Wills said, her speech interrupted by sobs. "It's hard when you have a terminally ill husband and every little minute counts."

Now she is concerned about who will provide her husband's regular and emergency medical care. She said trips to San Diego from their home in Lake Elsinore are arduous, taking as long as two hours.

She said her husband has consistently high ammonia levels in his blood — a result of the cirrhosis that is destroying his liver — and is often confused. The medication he takes to keep his blood pressure low makes traveling difficult. On top of that, she said, he has had heart trouble.

"I've always heard that UCI has some of the best doctors in the world; otherwise I wouldn't have been there," said the grandmother of eight.

We put all our trust into you people," she said of the program officials. "Why didn't you tell me you are turning organs away? I wouldn't have gone there."

Because transplant candidates are prioritized regionally according to medical need, transferring to another center does not mean that UCI patients will sink to the bottom of those hospitals' waiting lists.

But many are, for now, going from long waits to limbo, since they can't get livers without being assigned to one of the active transplant centers in the Southern California region.

Perhaps complicating matters, St. Vincent Medical Center, with 75 patients on its list, announced its closure last week, after a separate scandal. That brings the number of centers serving adults in the region to four.

So far, about half of St. Vincent's patients have been transferred to other hospitals' waiting lists.

At UCI, Beeman was one of 48 registered candidates who had been waiting more than three years.

He suffers from cirrhosis of the liver caused by hepatitis C, a chronic viral infection that he contracted through a blood transfusion he needed after breaking 12 ribs in a 1988 car accident. His health has been declining, although he is more stable than many on the waiting list.

"I had heard some very good things about UCI," he said. "They did good work. They seemed to have their ducks in a row."

Many staffers at the program knew it had significant problems, but Beeman, like many other patients, was never told.

Although he said he had noticed staff turnover in the program, Beeman was "shocked" to learn about the lack of a full-time surgeon since last year.

He didn't know the program had fallen far below state and federal guidelines requiring a minimum number of transplant surgeries each year to maintain proficiency. And he didn't know that the few patients who obtained transplants were dying at a significantly greater rate than at other programs in the region.

From 2002 to 2004, UCI surgeons transplanted eight livers each year, less than half the 18 required by the state to maintain proficiency, and four fewer than federal requirements. So far this year, five liver transplants had been performed.

"I wish they would have told me," he said. "It definitely might have changed what I did. I would have been talking to my HMO about my options, because there are financial considerations for me. I wish I could afford to go anywhere but I can't."

Beeman said he had been told that a patient without insurance coverage might be charged $300,000 for a liver transplant.

Lawrence Eisenberg, an Irvine attorney representing clients in current litigation against the liver transplant program, said "UCI had an ethical obligation to give full disclosure to the patients it was accepting into the liver transplant program."

Added Eisenberg, who also represented clients in the UCI fertility clinic scandal in 1995: "If you were a liver candidate and needed a transplant for survival, would you sign up with a center that did about half of the federal minimum guidelines on an annual basis?"

Beeman said he had faith all along that when his need became desperate, UCI would get him a new liver.

Asked how he feels now, he is brief: "Depressed," he said. "Stress is bad for someone with my condition, so I've really tried not to get angry."

On Friday, Beeman got a call from a UCI transplant program staff member, someone "I've gotten to talk to a lot over the years." He broke the news Beeman already knew. And he said UCI would help him get a transfer elsewhere.

But "it's not an overnight process," said Paul Silva, a spokesman for St. Vincent's, which is still seeking other centers for more than 30 of its former patients.

They have to be accepted, evaluated. Records have to be filed at the new center. We started with the patients who needed a liver in the next couple of weeks and worked from there."

UC Irvine officials say they too are hard at work arranging transfers.

UC Irvine Chancellor Dr. Michael V. Drake on Friday said hospital officials had contacted the 50 sickest patients on the waiting list and given the top cases to managers "to make sure they can be in touch with a proper transplant facility."

Beeman and his friends now look back regretfully on his years of waiting. He was at the ready every day. He never felt he could take a European vacation. He was always anxious about being any distance from the hospital.

"His whole life really revolves around his condition," said Linda Safford, a friend who has known Beeman since before the car accident and fateful blood transfusion.

Beeman said he had been doing all he could to help his cause. He took meditation to stay calm while waiting for test results. He joined support groups to talk to others in the same situation. He went regularly for checkups and testing.

Now he is troubled by doubt.

Is it possible that UCI declined a liver suitable for him?

Beeman closed his eyes, and thought.

"I guess I've learned that life can be unpredictable," he said. "Now it's going to take some scrambling and faith that things will work out."

Times staff writer Charles Ornstein contributed to this report.

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Canadian Study on Hepatitis C Treatment Based on Patient Weight Showed Consistent Results
SourceURL:http://www.axcessnews.com
By Eric Stevenson

(AXcess News) San Francisco - Schering-Plough Corporation (NYSE: SGP), which holds a global monopoly on PEG-INTRON (peginterferon alfa-2b) and REBETOL (ribavirin, USP) used in the treatment of chronic hepatitis C, sponsored a study in Canada that showed consistant results under real-life treatment of 952 patients across 160 clinics where doses of the drugs were given to patients based on weight. In the U.S. weight does not vary the amount of drugs prescribed.

Considering the pharmeceutical tactics Shering-Pough practices at U.S. clinics, where in many cases the drug company is literally officed within those facilities, AXcess News could not determine if that practice was conducted in Canada. Due to the drug manufacturers monopoly on the hepatitis C drug combination and the liver disease's deadly toll the Food and Drug Administration has not broached foreign generic manufacturing rights to the highly over-priced medication.

In the U.S., a patient prescribed by these Shering-Pough dominated medical clinics, or liver factories, pays $1,000 a month for the medication alone with no options for other, less expensive generic medications. Though in Canada, there may hope for some of the millions of people who suffer from this deadleast of diseases.

PEG-INTRON and REBETOL generate huge profits for Shering-Pough who defends their rates for the drug combination saying it cost them a lot to develop it. But that excuse runs thin as those without adequate or no medical insurance are unable to afford the costly drugs. Shering-Pough, which does have a program for dispensing the drugs to underprivileged sufferers of Hepatitis C do their best to not promote its existance - even going so far as coaching the liver clinics on dispensing the information sparingly.

But the results of the Canadian study did show encouraging consistencies in arresting the disease's progress.

The combination drug therapy achieved consistently high "Sustained Virological Response" (SVR) rates across all weight groups, with an overall SVR rate of 66 percent, the study showed. What that means is the virus did not multiply.

The hepatitis C virus is so resiliant that even household bleach can't kill it. Today there are estimated to be 10 million people in the world who test positive for the disease and many do not even know they've contracted it. Hepatitis C has been diagnosed to be in three viral types, with Genotype 1 the most common - and the most deadly. The virus simply eats the liver until the liver is so badly damaged it can no longer function. It is the most common reason for liver transplants in the world.

Body weight has been shown in previous studies to affect SVR. In this study, patients were treated, followed and managed per standard of care in a "real-life" treatment setting with no study-related intervention beyond collection of data, Shering-Pough said.

These results were reported for the first time at the 56th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD).

In the study, PEG-INTRON (1.5 mcg/kg weekly) and REBETOL (800 - 1200 mg daily) combination therapy achieved SVR rates of greater than 62 percent in all weight groups (ranging from 62.9 percent to 68.9 percent), with no significant differences in SVR between the different weight groups, in 952 patients for whom SVR results have been collected to date. As expected, a higher percentage of patients with genotypes 2 or 3 achieved an SVR (85 percent and 78 percent, respectively) than patients with genotype 1 (52 percent). Genotype 1 is the most common form of the virus and is considered the most difficult to treat successfully.

"These findings are particularly encouraging given that this is a 'real-life' community study with similar patient distribution by genotype within each weight group," said Paul Marotta, M.D., lead investigator, London (Ontario) Health Sciences Centre. "These results are consistent with the Canadian registration data for PEG-INTRON and REBETOL and underscore for patients the value of seeking treatment for hepatitis C, because the virus can be eradicated in a significant percentage of patients."

In the United States, PEG-INTRON (1.5 mcg/kg weekly) is approved in combination with REBETOL (800 mg daily) for a duration of treatment of 48 weeks. In the U.S. label, the SVR rate for this regimen is 52 percent. Weight-based dosing of REBETOL is currently under investigation in U.S. studies.

The study also revealed that 1% of the patients attempted or were successful at committing suicide either during or shortly after the treatment had ended.

In the U.S., in 2004 a 48-week treatment program would have cost $12,000 for the drugs alone. With 10 million estimated sufferers worldwide you can see why Shering-Pough will not give a license for the generic manufacture of the drugs and the Food and Drug Administration stands by, blind to the profits in excange for life tactics of this conciousless pharmaceutical company.

But there is one alternative to PEG-INTRON, which is manufactured by Roche Holding AG (VTX: ROG). Pegasys, a treatment for hepatitis C that helps those patients to suppress the virus who have failed to benefit from rival Schering-Plough's Peg-Intron, Roche said.

The Swiss drugmaker said on Friday that early results from a trial involving its Pegasys drug in combination with the antiviral ribavirin showed benefits in patients who had been unsuccessfully treated with Peg-Intron. Preliminary results from the trial showed that 47 percent of patients treated with the combination of Pegasys with ribavirin had undetectable amounts of the virus or a significant reduction in viral load after 12 weeks.

The results were presented at the American Society for the Study of the Liver.

Roche puts the number of people infected with hepatitis C at closer to 170 million worldwide.

Pegasys and Peg-Intron, injectable long-acting forms of the immune system protein interferon, are both used in combination with antiviral pill ribavirin.

Drug makers are now looking at researching new medicines that can be used in a cocktail with existing treatments.

In early-stage Phase I data presented on Friday, Schering-Plough's SCH 503034 compound, a protease inhibitor, showed it had potent antiviral activity when combined with Peg-Intron.

A similar drug by Vertex Pharmaceuticals Inc (Nasdaq: VRTX) is also moving to Phase II trials.

Idenix Pharmaceuticals Inc (Nasdaq: IDIX) said on Friday its drug NM283, in another class known as polymerase inhibitors, also worked well in combination with Pegasys. Novartis (VTX: NOVN) has an option to license in the pill.

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November 14th, 2005


Actilon(TM), Coley Pharmaceutical Group's Drug Candidate for Hepatitis C, Demonstrates Anti-Viral Activity in Early Clinical Evaluation
SourceURL:http://biz.yahoo.com

Data from the Company's Phase Ia and Phase Ib Clinical Studies Presented at the American Association for the Study of Liver Diseases Meeting

SAN FRANCISCO, Nov. 14 /PRNewswire-FirstCall/ -- Coley Pharmaceutical Group, Inc. (Nasdaq: COLY - News), announced results from the company's Phase Ia and Ib clinical studies of Actilon(TM) (CPG 10101), Coley's lead investigational TLR Therapeutic(TM) for Hepatitis C virus (HCV).

John D. McHutchison, M.D., Medical Director of Gastroenterology & Hepatology Research at the Duke Clinical Research Institute and lead investigator for both clinical studies, will be presenting these data today at the American Association for the Study of Liver Diseases (AASLD) meeting in San Francisco, CA.

"CPG 10101 has demonstrated encouraging anti-viral activity at doses that are well tolerated by patients," said Dr. McHutchison. "We observed a 1.6 mean log reduction of viral load, at the highest dose level tested, among predominantly genotype 1 patients and the induction of natural killer T-cells. These may be positive signs of Actilon's ability to promote both an immediate as well as long-term control of chronic Hepatitis C. Clinical results to date justify longer-term trials of this promising Hepatitis C agent as a monotherapy and in combination protocols with other anti-virals."

An oral presentation, "Relationship of HCV RNA Response to CPG 10101, a TLR9 Agonist - Pharmacodynamic and Patient Characteristics", will be given by Dr. McHutchison this afternoon at 4:00 p.m. and will review data from Coley's Phase Ib randomized clinical trial of Actilon in chronic Hepatitis C patients. Results of the Phase Ib study demonstrated that Actilon resulted in a dose- dependent decrease in HCV viral levels in the blood. At the highest dose tested, 0.75 mg/kg once weekly for four weeks, there was a 1.6 mean log reduction of serum HCV RNA levels among the predominantly genotype 1 Hepatitis C patients who were naive, intolerant of, or relapsed following treatment with pegylated interferon plus ribavirin therapy. The reduction in viral load observed correlated with certain antiviral biomarkers which were induced in a dose-dependent manner by Actilon.

A poster presentation entitled "Immunophenotyping Profile of CPG 10101, a New TLR Agonist Antiviral for Hepatitis C" evaluated the induction of immune system activity from both the Phase Ib study and Coley's Phase Ia clinical trial in healthy volunteers. These data show that Actilon activates, in a dose-dependent manner, several types of immune cells, including B cells, plasmacytoid dendritic cells, natural killer and natural killer-T cells. These are among the cells involved in both immediate (innate) and long-term (adaptive) immune responses.

"Actilon is designed to activate the immune system to respond in the same manner as it would if faced with a viral infection, mounting an immediate response to reduce viral load and a long-term, adaptive immune response to provide sustained anti-infective action. We are pleased by the results generated from these initial studies of Actilon supporting its dual mechanism of activity," said Arthur M. Krieg, M.D., Coley's Senior Vice President, Research and Development and Chief Scientific Officer. "We believe that Actilon's profile makes it an excellent candidate for use in combination with existing therapies and are currently evaluating its safety in an ongoing Phase Ib clinical study in patients who relapsed after previous therapy."

About the Actilon Phase I Clinical Studies
Coley's Phase Ia normal volunteer study was designed to evaluate Actilon's safety, dose tolerability and immunological activity. The study randomized forty healthy volunteers within five sequential dosing cohorts (0.25, 1, 4, 10 or 20 mg). Two subcutaneous injections were administered double-blind fourteen days apart and subjects were evaluated for a total of 29 days. An immune system response demonstrating drug-related increases in interferon-alpha levels and other markers indicative of antiviral activity was observed over the course of treatment. Volunteers had no drug-related serious adverse events or dose-limiting toxicities. Mild injection site reactions and mild-to-moderate flu-like symptoms were consistent with the pharmacological mode of action of Actilon.

The Phase Ib study enrolled 60 chronic Hepatitis C patients and was designed to evaluate safety and tolerability of Actilon over a wide dose range among patients who had relapsed after or were intolerant to prior interferon- alpha therapy. Subjects were randomized to receive doses of Actilon at 0.25, 1, 4, 10, and 20 mg twice weekly or 0.5 or 0.75 mg/kg once weekly or placebo for four weeks. Dose tolerance and laboratory safety were the same in HCV patients as in normal volunteers receiving equivalent doses.

In September of this year, Coley initiated a second Phase Ib study to evaluate Actilon's safety and antiviral activity as a monotherapy and in combinations with the current standard of care, pegylated interferon and ribavirin. Patients will be treated for at least 12 weeks. Those that show an antiviral response will be permitted to continue treatment for up to an additional 36 weeks. Approximately 60 adult HCV patients are being enrolled at up to eighteen centers and will be randomly assigned to one of five groups. Coley expects preliminary data from this Phase Ib study to be available in the first half of 2006.

About Coley Pharmaceutical Group
Coley Pharmaceutical Group, Inc. is an international biopharmaceutical company, headquartered in Wellesley, Massachusetts, USA, that discovers and develops TLR Therapeutics(TM), a new class of investigational drug candidates that direct the human immune system to fight cancers, infectious diseases, asthma and allergy. Coley has established a pipeline of four TLR Therapeutic product candidates currently advancing through clinical development either independently or with partners, and additional product candidates in preclinical development. Coley has product development, research and license agreements with Pfizer, sanofi-aventis, Chiron, GlaxoSmithKline and the United States government. For more information about the company, please visit www.coleypharma.com.

Safe Harbor Statement
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are based on current expectations of the Company's management. These statements include, but are not limited to, those relating to the design of, enrollment in, and anticipated results from future clinical trials of Actilon and Coley's ability to advance the discovery, development and commercialization of its TLR Therapeutics. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. They can be affected by inaccurate assumptions or by known or unknown risks and uncertainties, including the future success of ongoing and planned clinical trials, the unproven safety and efficacy of products under development, outcomes of regulatory approval processes, intellectual property rights and litigation, competitive products, the ability to obtain financing, and other risks identified in Coley's filings with the Securities and Exchange Commission including, but not limited to, Coley's Quarterly Report on Form 10- Q for the period ended September 30, 2005. Consequently, no forward-looking statement can be guaranteed, and actual results may vary materially. Coley undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise, except as required by applicable law.

Source: Coley Pharmaceutical Group, Inc.

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AASLD: Lighter Patients with Liver Cancer Fare Better
SourceURL:http://www.medpagetoday.com
By Neil Osterweil , MedPage Today Staff Writer
Reviewed by Rubeen K. Israni, M.D., Fellow, Renal-Electrolyte and Hypertension Division, University of Pennsylvania School of Medicine

MedPage Today Action Points

Advise patients who are at risk for hepatocellular carcinoma from HCV infection that maintaining a lean weight may help to ameliorate the course of the cancer should it develop, and may prolong their lives.

This study was published as an abstract and presented as a poster at a conference. These data and conclusions should be considered to be preliminary as they have not yet been reviewed and published in a peer-reviewed publication.

Review

SAN FRANCISCO, Nov. 14 - Jot down liver cancer on the list of conditions exacerbated by excess poundage.

That's the conclusion of Japanese researchers, who found that people who are obese and have hepatitis C virus (HCV)-associated hepatocellular carcinoma have significantly shorter survival than lean patients with liver cancer.

"Obesity may worsen the prognosis of people with hepatocellular carcinoma, and reduction of body weight may improve the clinical course and prognosis of people with HCV by delaying the development of hepatocellular carcinoma," Toshihiko Mazuta, M.D., and colleagues at Saga Medical School reported at the American Association for the Study of Liver Diseases meeting here.

An estimated 1.5 million people in Japan are infected with HCV, and approximately 30,000 Japanese die from hepatocellular carcinoma annually. More than 80% of the deaths are attributable to HCV-associated liver cancer, Dr. Mizuta said.

Because obesity has been implicated in epidemiological studies as a risk factor for hepatocellular carcinoma, and has been associated with a worse clinical course of HCV, Dr. Mizuta and colleagues decided to look at the influence of body mass index (BMI) on HCV related liver cancer.

They conducted a retrospective study of 150 consecutive patients with hepatocellular carcinoma and HCV antibody positivity. The patients were classified into four groups according to their BMI at time of hepatocellular carcinoma diagnosis: lean, with a BMI < 22 (57 patients), normal, with a BMI between 22 and 25 (56 patients), overweight, with a BMI 25 and 28, and obese with a BMI >28.

In an interview, Dr. Mizuta noted that although a definition of BMI > 28 as obese differs from that used in the United States (BMI > 30), Japanese people have traditionally been lean, and the comparison is therefore a relative one.

They looked at differences of age, gender, alcohol consumption, smoking (packs/year), diabetes, and hepatic function, as measured by ALT and albumin levels, prothrombin activity, and Child-Pugh class.

They found that lean patients had significantly lower liver enzyme (serum ALT) levels compared with the normal group, but not compared with the overweight or obese cohorts.

When they looked at serum albumin concentration and prothrombin activity, however, they found that levels gradually decreased as BMI increased. For example, albumin concentrations were 3.6 g/dl in lean patients, compared with 3.2 in obese patients. Prothrombin activity declined from 74% among the lightest, patients, to 66% among those who were obese.

In addition, the severity of disease as measured by the ratio of Child-Pugh C class in each group increased in association with BMI. Only 5% of lean patients had Child-Pugh class C disease, compared with 38% of obese patients. "There were no differences in gender, alcohol, smoking, and diabetes among the four groups," added Dr. Mizuta.

They used a Kaplan-Meier analysis to look at the relationship between BMI and cumulative survival rates after treatment for 80 patients with early stage cancer (stage I or II). "The cumulative survival rate of the obese group was significantly lower than that of the other groups," Dr. Mizuta and colleagues noted in this analysis.

In a multivariate analysis, a BMI > 28 proved to be the only independent factor associated with poor prognosis, they found.

"BMI influences the onset age of hepatocellular carcinoma and hepatic function; further, obesity is a poor prognostic factor in patients with HCV -related hepatocellular carcinoma," they wrote.

Primary source: 2005 AASLD Meeting

Source reference:

Mizuta T et al. Body mass index influences hepatic function and survival prognosis in patients with HCV-related hepatocellular carcinoma. Abstract 463, presented Nov. 13, 2005.

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Vertex Pharma's VX-950 Could Be Leading Hep C Drug
SourceURL:http://www.forbes.com
Peter Kang
Source: Vertex Pharmaceuticals

Bear Stearns maintained an "outperform" rating on Vertex Pharmaceuticals (nasdaq: VRTX - news - people ) after the recent release of positive clinical data for experimental hepatitis treatment.

The specialty pharmaceutical firm provided viral resistance data from a Phase Ib study of VX-950, a protease inhibitor for hepatitis C patients.

"We are very encouraged by this data, primarily due to the lack of more resistant strains than the previously identified A156 variant, the correlation with decreased sensitivity to VX-950 and reduced fitness of the variant, and inability to detect variants in the optimal dose arm," wrote analyst Akhtar Samad, in a note to clients.

Vertex also said it filed an investigational new drug application with federal health regulators to begin a broad Phase II study. The research analyst maintained a price target of $31 and said Vertex remains a top sector pick heading into 2006.

"We believe VX-950 could emerge as the leading protease inhibitor drug for HCV therapy, addressing a large market opportunity with premium pricing, and potentially securing a first-to-market advantage (we anticipate a potential second-half 2009 launch in the U.S., despite the current advancement of a competing protease inhibitor, SCH7 from Schering-Plough (nyse: SGP - news - people ), into a phase II trial ahead of Vertex)," said Samad.

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Five-Year Data Evaluating Long-Term Therapy with Hepsera(R) for Hepatitis B ''e'' Antigen-Negative Chronic Hepatitis B Presented at AASLD Annual Meeting
SourceURL:http://biz.yahoo.com/

Data Indicate that Hepsera May Lead to Regression of Liver Fibrosis in Patients Treated for up to Five Years

SAN FRANCISCO--(BUSINESS WIRE)--Nov. 14, 2005--Gilead Sciences (Nasdaq:GILD - News) today presented data describing the sustained efficacy and safety of its oral antiviral drug Hepsera® (adefovir dipivoxil) for up to five years of treatment among patients with hepatitis B "e" antigen-negative, presumed precore mutant chronic hepatitis B. In this analysis, which includes the first prospective set of liver biopsies following five years of oral antiviral therapy, treatment with Hepsera resulted in regression of liver fibrosis in 75 percent of patients. Liver fibrosis is a serious consequence of chronic liver inflammation. Study results were presented as a late breaker poster (#LB12) at the 56th American Association for the Study of Liver Diseases Annual Meeting in San Francisco, CA.

"This study offers long-term evidence of antiviral efficacy and clinical benefit among patients with a difficult-to-treat form of chronic hepatitis B," said Stephanos Hadziyannis, MD, Department of Medicine, Henry Dunant Hospital, Athens, Greece, and a lead investigator for Study 438. "Long-term therapy is often the rule for patients with HBeAg-negative hepatitis B, and other oral antiviral therapies either lack long-term data in this population or lead to the development of genotypic resistance at high rates after only a few years. The data presented indicate that Hepsera may be able to reverse signs of liver damage in patients who received up to five years of continuous treatment, with a relatively low rate of resistance."

Dr. Hadziyannis presented efficacy, tolerability, resistance and safety data from an open-label extension of Study 438, in which patients with HBeAg-negative chronic hepatitis B received Hepsera monotherapy continuously for up to 240 weeks.

Liver biopsies at years one, two, four and five (240 weeks) showed continual improvement in inflammation and regression of fibrosis. Eighty-three percent (20/24) and 75 percent (18/24) of patients showed improvement in inflammation and regression of fibrosis following 240 weeks of Hepsera treatment, respectively. Sixty-nine percent (38/55) of patients who received Hepsera for 240 weeks exhibited improvement in liver function, as measured by normalization of serum alanine transferase (ALT) levels. Sixty-seven percent (37/55) of patients had suppression of viral replication, indicated by undetectable levels of serum HBV DNA (less than 1,000 copies/mL). In addition, four patients experienced HBsAg loss. Three of the four patients showed sAg seroconversion (complete loss of HBsAg and the development of antibodies to the HB "surface" antigen) by the end of the evaluation. Data from this study also showed that biochemical, virologic, serological and histological results in the 240-week treatment group were similar to those in a separate cohort of patients treated with placebo for the first year and Hepsera monotherapy for four years (192 weeks), indicating that therapy with Hepsera is associated with sustained improvements in patients with HBeAg-negative chronic hepatitis B.

Two mutations (rtN236T and rtA181V) in the HBV polymerase enzyme have been associated with genotypic resistance to Hepsera. According to a life-table analysis, the cumulative probability of selecting these viral mutations with Hepsera was 0, 3, 11, 18 and 29 percent after 48, 96, 144, 192 and 240 weeks of treatment, respectively. These mutations are indicators of the potential for clinical breakthrough.

The safety profile of Hepsera remained favorable through 240 weeks of treatment. Four patients (3 percent) had a confirmed increase in serum creatinine of greater than or equal to 0.5 mg/dL from baseline by week 240 and of those one patient discontinued the study. One patient had a serum phosphorous level less than 2.0 mg/dL, which was observed after discontinuation of therapy. Serious adverse events were reported in 19 percent (24/125) of patients in the study; none were determined to be related to Hepsera. Three patients (2 percent) discontinued from the study due to adverse events.

About Hepsera
Hepsera, a nucleotide analogue for the treatment of chronic hepatitis B, works by inhibiting HBV DNA polymerase, an enzyme involved in the replication of the virus in the body.

In the United States, Hepsera is indicated for the treatment of chronic hepatitis B in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

Clinical and laboratory evidence of exacerbations of hepatitis have occurred after discontinuation of treatment with antiviral therapies for hepatitis B, including Hepsera. Special warnings and precautions for use are included in the package insert regarding monitoring of renal function, post-treatment exacerbations of hepatitis, and the occurrence of lactic acidosis and severe hepatomegaly with steatosis. The adverse reactions considered at least possibly related to treatment reported in 3 percent or greater of patients in the first 48 weeks in Hepsera pivotal clinical studies were asthenia, headache, abdominal pain, nausea, flatulence, diarrhea and dyspepsia. Patients who received Hepsera beyond 48 weeks reported adverse reactions similar in nature and severity to those reported in the first 48 weeks of treatment with only a slight increase in incidence. By week 96, increases in serum creatinine were observed in patients with chronic hepatitis B and compensated liver disease treated with Hepsera. Changes in serum creatinine were more prevalent in patients pre- and post-transplantation with lamivudine-resistant liver disease and multiple risk factors for changes in renal function who were treated with Hepsera for up to 129 weeks, with a median time on treatment of 19 and 56 weeks, respectively. Dosing instructions for patients with underlying renal impairment and for patients co-infected with HIV are also provided in the package insert, which is available for download online at www.hepsera.com.

About Chronic Hepatitis B
Chronic hepatitis B is a serious disease that can lead to potentially fatal complications such as cirrhosis and liver cancer. More than 400 million people are estimated to be chronically infected with HBV worldwide, with approximately 1.25 million people infected in the United States alone. HBeAg-negative hepatitis B accounts for approximately 14 to 33 percent of chronic hepatitis B cases worldwide.

About Gilead
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.

This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors. These risks and uncertainties could cause actual results to differ materially from those referred to in the forward-looking statements. Risks are described in detail in the Gilead Annual Report on Form 10-K for the year ended December 31, 2004 and in Gilead's Quarterly Reports on Form 10-Q, all of which are on file with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead and Gilead assumes no obligation to update any such forward-looking statements.

Hepsera is a registered trademark of Gilead Sciences, Inc.

For more information on Gilead, please call the Gilead Public Affairs Department at 1-800-GILEAD-5 (1-800-445-3235) or visit www.gilead.com.

Contact:

Gilead Sciences, Inc.
Susan Hubbard, 650-522-5715 (Investors)
Erin Edgley, 650-522-5635 (Media)

Source: Gilead Sciences, Inc.

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Prisons ‘Failing’ on HIV and Hepatitis C
http://www.4ni.co.uk/

Prisons are failing to halt the spread of HIV and hepatitis C, a joint report by two charities has claimed.

The report, conducted by the Prison Reform Trust and the National AIDS Trust, criticised prison healthcare as “inconsistent and often sub-standard”.

The survey found that over half of prisons have no sexual health policy in place. However, researchers found that 9% of male prisoners and 11% of female prisoners have hepatitis C ­ twenty times higher than the rate of the general public.

The HIV rate among male prisoners was also found to be 15 times higher than the rate of the general public.

The report found that some prisoners thought that HIV-positive inmates would be subjected to bullying and discrimination if their health status were known.

Researchers also found that many prisoners did not have access to condoms, disinfecting tablets, clean needles or healthcare information.

Ruth Runciman, Chair of the National AIDS Trust and Deputy Chair of the Prison Reform Trust, said: “Overcrowding and the constant movement of prisoners between establishments create particularly adverse conditions in our prisons for curbing the spread of HIV and hepatitis and there is an urgent need to develop policy and practice to protect individuals and public health.”

The report made a series of recommendations, ahead of the transfer of responsibility for prisoners’ healthcare to the NHS, which is due to be completed by April 2006. The recommendations include: free condoms; access to methadone programmes, disinfecting tablets and needle exchanges; and regular anonymous blood tests to establish levels of HIV and hepatitis C infection.

Juliet Lyon, director of the Prison Reform Trust, said: “Courts sentence people to custody not to inadequate healthcare. The prison population is marked by poor health. It is time the NHS developed good, well-resourced policy and practice to tackle blood-borne disease in prison. Anything else would amount to double punishment and lead to public health risk.”

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Bristol-Myers Posts Baraclude Data
SourceURL:http://biz.yahoo.com

Bristol-Myers Squibb Baraclude Data Shows Lowering of Hepatitis B Levels in More Patients

SAN FRANCISCO (AP) -- Drug maker Bristol-Myers Squibb Co. said Monday that twice as many patients taking Baraclude had their hepatitis B virus levels lowered to undetectable levels compared with those patients taking lamivudine, the active ingredient in GlaxoSmithKline PLC's antiviral treatment Epivir.

After 96 weeks of treatment, Bristol-Myers Squibb said that 80 percent of patients given 0.5 milligrams of Baraclude daily had undetectable levels of the virus compared to 39 percent of patients given 100 milligrams of lamivudine daily.

The study also found that no patients had a noticeable rebound of the virus attributed to Baraclude after two years of treatment. However, in patients who were unresponsive to lamivudine, 9 percent of Baraclude patients taking the drug experienced a rebound of the virus. The company said all patients whose virus rebounded had mutations attributed to previous lamivudine treatment.

Baraclude was approved by the Food and Drug Administration for hepatitis B in March. Representatives for GlaxoSmithKline were not available for immediate comment.

On the New York Stock Exchange, Bristol-Myers Squibb shares fell 26 cents to $21.83, and American depositary receipts of GlaxoSmithKline fell 34 cents to $53.19 in morning trading.

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November 15th, 2005


Hepatitis C Transmission: More on the Link with Drugs and Unprotected Sex
SourceURL:http://www.aidsmap.com/
Liz Highleyman

A variety of factors related to sexual activity and drug use have contributed to an outbreak of hepatitis C among HIV-positive gay men in Southeast England in recent years, according to a presentation by Mark Danta from the Royal Free and University College Medical School at the American Association for the Study of Liver Diseases meeting in San Francisco on November 13.

More than 200 cases of acute hepatitis C virus infection have been diagnosed in HIV-positive gay men seen at the Royal Free Hospital, Chelsea and Westminster Hospital, and University College Hospital in London; an additional twelve cases have been detected in Brighton. AIDS Treatment Update published the first reports about this new sexually transmitted hepatitis C virus epidemic in 2002, and aidsmap has since reported on its developments.

The current study aimed to characterise the mode of hepatitis C transmission using both molecular analysis and a case-control examination of risk factors. The study included 111 HIV-positive gay men with acute hepatitis C recruited since 2002 from HIV units at Chelsea and Westminster (50 cases), Royal Free Hospital (50 cases), and Brighton Hospital (eleven cases). The median age was 36 years, 65% were on antiretroviral therapy, and the mean CD4 cell count at diagnosis was 552 cells/mm3. Most of the men (88%) had hepatitis C genotype 1, 8% had genotype 3, and 4% had genotype 4. About one-third (30%) had been diagnosed with syphilis within the year prior to contracting hepatitis C.

In the molecular analysis, the researchers constructed phylogenetic trees using the E1/E2 sequence of the hepatitis C virus genome to illustrate the relatedness between the men's specific viral variants. The genome patterns clustered into several distinct monophyletic "clades," or lineages, providing strong evidence for common sources of HCV transmission. Because the clusters crossed subtypes and genotypes, the analysis suggested that, "this epidemic is not due to a hepatitis C viral change, but rather behavioural and/or environmental factors," Dr Danta reported.

In the epidemiological study, 60 patients with acute hepatitis C and 130 matched HIV-positive/hepatitis C virus-negative controls completed questionnaires about their risk factors over the twelve months preceding hepatitis C virus diagnosis. Baseline characteristics were similar in both groups, although the case patients were less likely than the controls to be on anti-HIV therapy.

In terms of risk factors, men with acute hepatitis C were more than twice as likely as control subjects to be injecting drug users (17% vs 7%; p = 0.08), although the overall rate was low compared to other hepatitis C virus-infected populations. Cases were also somewhat more likely to have tattoos (60% vs 44%); piercings (70% vs 52%; p = 0.03); and a history of blood transfusion (17% vs 8%). Because most tattooing and piercing was done under sterile conditions, however, Dr Danta suggested that hepatitis C infection was "not really attributable"to these factors.

Similar percentages of men in both groups met sex partners in bars or clubs, at private parties, or in public cruising areas. But men with acute hepatitis C were significantly more likely to meet partners in sex clubs/bathhouses/saunas (approximately 4% vs 1%; p = 0.01) or on the Internet (approximately 49% vs 8%; p = 0.003). The hepatitis C-infected men had a median 30 sex partners in the past year, compared with ten for controls (p = 0.001); in both groups, a majority of these partners were "one-night stands."

Looking at specific sexual practices, hepatitis C-infected men were significantly more likely than control subjects to have engaged in unprotected receptive or insertive anal intercourse (p < 0.001), receptive or insertive fisting (p < 0.001), use of sex toys (p < 0.001), receptive or active analingus ("rimming"), S&M, and group sex; rates of protected receptive and insertive anal intercourse were similar in both groups. The largest difference was seen in the rates of insertive fisting (about three times higher among the hepatitis C - infected men) and receptive fisting (about four times higher).

Men with acute hepatitis C were significantly more likely to have ever had syphilis, gonorrhoea, and non-specific urethritis (all p < 0.01). But overall, most men in both groups had a history of any sexually transmitted infection: 92% for the hepatitis C-infected men and 78% for the control subjects (p < 0.01).

The hepatitis C-infected men were significantly more likely to have had sex under the influence of drugs (92% vs 62%; p < 0.001). Use of various "club drugs" including crystal methamphetamine, ketamine, GHB, and ecstasy was significantly more common among men with acute hepatitis C (p = 0.006 or less). While injecting drug use was uncommon in both groups, hepatitis C-infected men were significantly more likely to have shared paraphernalia for intranasal drug use (approximately 79% vs 49%; p < 0.001).

Summarizing these findings, Dr Danta concluded that various high-risk sexual practices, meeting partners online, the use of "club drugs," and sharing equipment for intranasal drug use are all linked to hepatitis C transmission among HIV-positive gay men. However, because there is considerable overlap among these factors, it is difficult to tease out their relative contributions. Since high-risk sexual and drug use practices appear to be driving this epidemic – as opposed to traditional parenteral risk factors – he recommended that education about safe sex and drug-sharing practices should be the focus of preventive public health interventions.

Reference

Danta M. et al. Evidence for sexual transmission of HCV in recent epidemic in HIV-infected men in South-East England. 56th Annual Meeting of the American Association for the Study of Liver Diseases, San Francisco, abstract 67040, 2005.

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Human Genome Sciences Reports Interim Results of Phase 2 Clinical Trial of Albuferon(TM) in Combination with Ribavirin in Treatment-Experienced Hepatitis C Patients
www.prnewswire.com

ROCKVILLE, Md., Nov. 15 /PRNewswire-FirstCall/ -- Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced the interim results of a Phase 2 clinical trial to evaluate the safety, tolerability and efficacy of Albuferon(TM) (albumin-interferon alpha) in combination with ribavirin (RBV) in patients with chronic hepatitis C who failed to respond to previous interferon alpha-based treatment regimens. The results to date demonstrate that Albuferon in combination with RBV was safe, well tolerated and showed robust antiviral activity.

The results were presented today in San Francisco at the 56th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in an oral presentation entitled "A Phase 2 Study of Albuferon in Combination with Ribavirin in Non-Responders to Prior Interferon Therapy for Chronic Hepatitis C."(1) The trial is a Phase 2, randomized, open-label, multi-center, dose-escalation study, and is being conducted in the United States in patients who have failed to respond to any previous interferon alpha-based treatment regimen. The study design states that approximately 50 percent of the subjects enrolled should be patients who have failed combination therapy that included pegylated interferon alpha plus ribavirin. To date, a total of 115 patients have been enrolled and randomized into 5 Albuferon treatment groups that are receiving doses of Albuferon ranging from 900-1800 mcg.(2) Patients are receiving Albuferon administered subcutaneously at intervals of either 14 or 28 days, with all patients receiving weight-based oral RBV daily at 1000 or 1200 mg in two divided doses. Patients in the trial will receive 48 weeks of treatment, with an additional 24 weeks of follow-up. The primary objective of the Phase 2 study is to evaluate the safety and tolerability of Albuferon in combination with RBV in patients who have not responded to previous treatment with regimens containing interferon alpha or pegylated interferon alpha. The study also is evaluating the efficacy of Albuferon in combination with RBV. The primary efficacy endpoint is sustained virologic response (SVR), defined as undetectable virus at 24 weeks after the end of therapy.

Data were presented today through Week 24 of the 48-week study on 71 patients who were enrolled in parallel and randomized into three Albuferon treatment cohorts: 900 mcg administered subcutaneously every 14 days, 1200 mcg administered subcutaneously every 14 days, and 1200 mcg administered subcutaneously every 28 days -- with all patients receiving weight-based oral RBV daily at 1000 or 1200 mg in two divided doses. 64.8% (46/71) of the study subjects were non-responders to pegylated interferon alpha, and 93% (66/71) were infected with genotype 1 hepatitis C. More than 60% of the study subjects had received more than one prior interferon alpha-based treatment regimen, and the mean duration of prior therapy was approximately 15 months.

At Week 24, 30% of the patients had no detectable hepatitis C RNA viral load. (The primary efficacy endpoint is SVR, defined as undetectable virus at 24 weeks after the end of 48 weeks of therapy.) Antiviral activity was similar for the 14-day and 28-day Albuferon treatment cohorts. Albuferon in combination with RBV was well tolerated. The most common adverse events were fatigue, headache, myalgia and nausea. No significant increase in the severity of adverse events was observed between Week 12 and Week 24, and incidence of adverse events was similar across the three dose cohorts for which data are available. No subject required discontinuation of either Albuferon or RBV for hematological abnormalities. Six subjects developed newly emergent antibodies to interferon alpha; no subject developed treatment-emergent antibodies to human serum albumin. There was no apparent correlation between the emergence of antibodies and antiviral response, adverse events or pharmacokinetics.

David Nelson, M.D., a lead investigator in the Phase 2 study, and Associate Professor of Medicine, Medical Director of Liver Transplantation, and Chief of the Hepatobiliary Diseases Section, University of Florida, Gainesville, said, "The interim data presented today at the AASLD meeting demonstrate that Albuferon in combination with ribavirin was well tolerated and exhibited a robust antiviral activity in this treatment-experienced patient population, with a pharmacokinetic profile that supports dosing at intervals of two to four weeks. We observed that 30% of the patients in the current study had no detectable HCV viral load at Week 24, with little difference in antiviral activity between the 14-day and 28-day Albuferon treatment cohorts. Based on the clinical and preclinical evidence to date(3-11), we look forward to continuing the evaluation of Albuferon in combination with ribavirin at higher doses and over the full term of the current study."

David C. Stump, M.D., Executive Vice President, Drug Development, said, "The interim results presented at AASLD today are strongly supportive of our broadening program of clinical study of Albuferon's potential role as an important therapeutic option for the treatment of hepatitis C.(12) Nearly two thirds of the study population were non-responders to previous treatment with regimens that included pegylated interferon alpha, with more than 60% of the study participants having received more than one prior interferon alpha-based treatment regimen. I am encouraged that approximately 30% of these heavily pretreated patients exhibited no detectable hepatitis C RNA viral load after 24 weeks and that the antiviral activity was robust and similar for the Albuferon treatment cohorts dosed at 14-day and 28-day intervals. The data show that Albuferon in combination with ribavirin was well tolerated, with transient adverse events that were mostly mild to moderate in severity, and with no discontinuations due to adverse events. The rates of newly emergent antibodies to interferon alpha were consistent with those reported for other interferon alpha-based therapies, with no apparent correlation between the emergence of these antibodies and adverse events, antiviral response or pharmacokinetics. We look forward to presentation of additional interim results from the current study, including data from higher-dose cohorts, at an appropriate scientific meeting in the first half of 2006."

The results of a Phase 2 clinical trial of Albuferon monotherapy in interferon alpha-naive patients with genotype 1 chronic hepatitis C were presented in April 2005 at the 40th Annual Meeting of the European Association for the Study of the Liver (EASL).(5-6) Data presented on 56 patients demonstrated that Albuferon exhibited robust antiviral activity in genotype 1 HCV. A mean reduction in HCV viral load of 3.2 log at Day 28 was observed in the combined 900 mcg and 1200 mcg dose cohorts, with 69% of patients (18/26) in these cohorts showing a >2-log reduction in HCV viral load at Day 28. Undetectable viral load was observed at Day 42 (28 days after the second injection) in 23% of patients (6/26) in the combined 900 mcg and 1200 mcg dose cohorts. Robust dose-dependent viral kinetics were observed, with the majority of patients in the 900 mcg and 1200 mcg cohorts exhibiting a second-phase decline in viral load of >0.3 log per week, which has previously been shown to be predictive of sustained virologic response (SVR) in treatment with the pegylated interferons.(13) Reductions in viral load of equal to or greater than 2 log are reported in approximately 42% of genotype 1 HCV patients treated with pegylated interferon alpha products in combination with ribavirin.(14) The results presented at EASL demonstrate that Albuferon remained in the blood substantially longer than is reported for recombinant interferon alpha and pegylated interferon alpha. Albuferon exhibited a median half-life of 148 hours, supporting dosing at intervals of 2-4 weeks. This compares with a reported mean (range) elimination half-life of 80 hours (50-140 hours) for Pegasys and 40 hours (22-60 hours) for PEG-Intron.(15-16) Albuferon was well tolerated with adverse events that were transient and mostly mild to moderate in severity. There were no discontinuations due to reductions in hematologic cell counts. No subjects developed newly emergent antibodies to alpha interferon.

Human Genome Sciences has completed enrollment and initial dosing in a larger Phase 2b clinical trial to evaluate the efficacy and safety of Albuferon in combination with ribavirin in patients with HCV genotype 1 who are naive to interferon alpha-based treatment regimens.(12) A total of 458 patients have been enrolled in the randomized, open-label, multi-center, active-controlled, dose-ranging study, which is being conducted in Australia, Canada, Czech Republic, France, Germany, Israel, Poland and Romania. Patients have been randomized into four treatment groups, three of which receive subcutaneously administered Albuferon (900 mcg at 14-day intervals, 1200 mcg at 14-day intervals, and 1200 mcg at 28-day intervals). The fourth treatment group serves as the active control group and receives weekly 180-mcg doses of subcutaneously administered Pegasys (peginterferon alfa-2a). All patients receive weight-based oral daily ribavirin at 1000 or 1200 mg in two divided doses.

Albuferon is a novel, long-acting form of interferon alpha. It is a Human Genome Sciences drug made possible by the company's proprietary albumin fusion technology, which was used to improve the pharmacological properties of interferon alpha. Recombinant interferon alpha is approved for the treatment of hepatitis C, hepatitis B and a broad range of cancers. Human Genome Sciences is developing Albuferon for use in the treatment of chronic hepatitis C.

Hepatitis C infection is an inflammation of the liver caused by the hepatitis C virus. It is the most common chronic blood-borne infection in the developed world. It is estimated that as many as 170 million people worldwide are infected with hepatitis C virus. This includes nearly four million people in the United States. The hepatitis C virus is transmitted primarily through significant or repeated exposures to infected blood. Intravenous drug use and sexual contact with infected persons account for the majority of new hepatitis C infections. When detectable levels of the hepatitis C virus in the blood persist for at least six months, a person is diagnosed as having chronic hepatitis C.

Human Genome Sciences is a company with the mission to discover, develop, manufacture and market innovative drugs that serve patients with unmet medical needs, with a primary focus on protein and antibody drugs.

For more information about Albuferon, see http://www.hgsi.com/products/albuferon.html. Health professionals interested in more information about trials involving Human Genome Sciences products are encouraged to inquire via the Contact Us section of the company's web site, http://www.hgsi.com/products/request.html, or by calling (301) 610-5790, extension 3550.

HGS, Human Genome Sciences and Albuferon are trademarks of Human Genome Sciences, Inc.

This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements are based on Human Genome Sciences' current intent, belief and expectations. These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are difficult to predict. Actual results may differ materially from these forward-looking statements because of the Company's unproven business model, its dependence on new technologies, the uncertainty and timing of clinical trials, the Company's ability to develop and commercialize products, its dependence on collaborators for services and revenue, its substantial indebtedness and lease obligations, its changing requirements and costs associated with planned facilities, intense competition, the uncertainty of patent and intellectual property protection, the Company's dependence on key management and key suppliers, the uncertainty of regulation of products, the impact of future alliances or transactions and other risks described in the Company's filings with the Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. Human Genome Sciences undertakes no obligation to update or revise the information contained in this announcement whether as a result of new information, future events or circumstances or otherwise.

Footnotes:

1. Nelson DR, et al. A Phase 2 study of Albuferon in combination with ribavirin in non-responders to prior interferon therapy for chronic hepatitis C. 56th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), 2005. Oral Presentation #204.
2. It is important to note that the method of measurement for dose determination in the Phase 2 study of Albuferon in combination with ribavirin in treatment-experienced patients (as well as in other Phase 2 studies of the compound) is different from the method of measurement in the Phase 1/2 study of Albuferon. Accordingly, the 900-mcg dose in the current study is equivalent to a 680-mcg dose in the Phase 1/2 study, and the 1200-mcg dose is equivalent to 900 mcg in the Phase 1/2 study.
3. Liu C, Zhu H, Xu Y, Nelson DR, et al. Albuferon(TM) exhibits efficient anti-HCV activity in cell culture. Digestive Disease Week (DDW) 2005, Chicago. Abstract #S920.
4. (HGSI Press Release) Human Genome Sciences Reports Results of Preclinical Study Comparing Anti-Viral Activity of Albuferon and Three Other Forms of Interferon Alpha Used to Treat Hepatitis C. May 17, 2005.
5. Bain V, et al. A Phase 2 study to assess antiviral response, safety, and pharmacokinetics of Albuferon in IFNalpha-naive subjects with genotype 1 chronic hepatitis C. 40th Annual Meeting of the European Association for the Study of the Liver (EASL), Paris. April 14, 2005. Oral presentation. Abstract #18.
6. (HGSI Press Release) Human Genome Sciences Reports Positive Results of Phase 2 Clinical Trial of Albuferon in Treatment-Naive Patients with Chronic Hepatitis C. April 14, 2005.
7. Moore P, Balan V, et al. Modulation of interferon specific gene expression by Albuferon in subjects with chronic hepatitis C and correlation with anti-viral response. 40th Annual Meeting of the European Association for the Study of the Liver (EASL), Paris. April 14, 2005. Abstract #447.
8. Balan V, et al. Albuferon(TM) -- A Novel Therapeutic Agent for Hepatitis C: Results of a Phase 1/2 Study in Treatment Experienced Subjects with Chronic Hepatitis C. 55th Annual Meeting of the American Association for the Study of Liver Diseases, Boston. November 2, 2004. Oral presentation Abstract #265.
9. (HGSI Press Release) Human Genome Sciences Reports Positive Results of Phase 1/2 Clinical Trial of Albuferon(TM) in Chronic Hepatitis C. November 2, 2004.
10. Balan V, et al. Molecular profiles of drug response in HCV infected patients during the first four weeks of therapy for chronic hepatitis C virus with pegylated interferon containing regimens or Albuferon. 54th Annual Meeting of the American Association for the Study of Liver Diseases, Boston. October 25, 2003.
11. Osborn B, Olsen H, Nardelli B, et al. Pharmacokinetic and pharmacodynamic studies of a human serum albumin-interferon-a fusion protein in cynomolgus monkeys. J Pharmacol Exp Ther 2002: Nov; 303: 540-548.
12. (HGSI Press Release) Human Genome Sciences Completes Patient Enrollment in a Phase 2b Clinical Trial of Albuferon in Combination with Ribavirin in Treatment-Naive Patients with Chronic Hepatitis C. October 25, 2005.
13. Neumann AU et al. The second phase HCV decline slope is the best predictor of sustained viral response during treatment of chronic HCV genotype 1 patients with peg-interferon-a-2b and ribavirin. 53rd Annual Meeting of the American Association for the Study of Liver Diseases, Boston. November 1-5, 2002. Abstract #778. Hepatology 2002: Vol 36 No 4, Pt 2 of 2.
14. Di Bisceglie AM, Rustgi VK, Thuluvath P, et al. Pharmacokinetics and pharmacodynamics of pegylated interferon alfa-2a or alfa-2b with ribavirin in treatment naive patients with genotype 1 chronic hepatitis C. Hepatology 2004;40,4;734a, abstract LB18.
15. PEGASYS(R) Physicians Desk Reference. (Last updated December 2003).
16. PEG-INTRON(R) Physicians Desk Reference. (Last updated February 2005).

SOURCE Human Genome Sciences, Inc.

Web Site: http://www.hgsi.com

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Teacher Claims She Got Hepatitis on Job
www.wnbc.com
Carol Anne Riddell

NEW YORK -- A teacher's aide and a teachers union blamed the lax safety standards of the New York City Board of Education after she was diagnosed with hepatitis-C, which she said she contracted on the job.

"I was diagnosed with hepatitis-C in April of 2003," said Lori Barron. "I was devastated."

Barron said she caught the disease while working with special needs children at a program located inside Beach Channel High School in Rockaway Park, Queens.

She said her students sometimes bit and scratched her, exposing her to their blood. She said she wasn't trained to deal with such potential health risks, nor was she routinely given protective equipment.

"I recall being told directly there were not enough gloves, so use gloves sparingly, or don't use the gloves, because it makes the children feel bad," said Barron.

The United Federation of Teachers says Barron is not alone. According to the union, 128 staff members report being exposed to blood-borne pathogens at work. Of those, 58 were bitten and 64 were scratched.

"There are standards about how to deal with blood in hospitals and schools, and the Board of Education routinely ignores these standards," said Randi Weingarten, president of the United Federation of Teachers. "As a result, both staff and in some instances children have gotten sick."

It is not unusual for special education teachers to be bitten or scratched by students, and teachers also come in contact with bodily fluids and waste of students, Weingarten said at a news conference.

Robyn Harland, a special education teacher at P.S. 233 in the Far Rockaway section of Queens, said teachers have to clean up children covered in diarrhea without gloves or a protective gown.

The New York Department of Labor told NewsChannel 4 that there are violations at Beach Channel, adding the city's Department of Education is being fined more than $2,000 a week.

Officials, however, contend the citation is without merit. In a statement, the Department of Education said the safety of their students and employees is "paramount."

"We have been operating for years according to a detailed plan that includes regular training to prevent exposure to blood-borne pathogens, the distribution of gloves to employees … and hepatitis-B vaccines," the statement said.

In addition, a Department of Education spokeswoman said the city will be distributing protective aprons and sleeves by December.

As for Barron, she still works at the school, but is filing a lawsuit because of her suffering.

"Am I angry?" she said. "You bet. I'm furious. And I will do everything in my power to make sure no other person suffers as I have suffered and continue to suffer."

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Legal Move in Hep C Blood Battle
SourceURL:http://news.bbc.co.uk

Families want answers over the use of contaminated blood

Relatives pushing for a judicial review into hepatitis C deaths from infected blood have asked a court to limit the costs in the event their case fails.

About 550 patients received contaminated blood in Scotland in the 1970s and 1980s.

Their families believe the full truth has never been properly investigated.

Lawyers for three victims have urged the Court of Session in Edinburgh to limit the liability to £50,000, or they may have to abandon the action.

Scottish Executive ministers have refused to order a public investigation.

This legal action for a judicial review is at a very early stage.

'Public interest'

The three families bringing the case had hoped the Health Minister Andy Kerr and Lord Advocate Colin Boyd would agree to the families' expenses being capped at £50,000.

But the minister and Lord Advocate have refused.

The families have stressed they are not asking for any compensation, but said there was a clear public interest in establishing what happened.

They said Scotland was using Hep C contaminated blood some 18 months after England was using a treatment programme which killed the virus.

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Idenix Hepatitis C Pill Shows Promises in Trial
SourceURL:http://www.pharmabiz.com

Valopicitabine combined with pegylated interferon demonstrated significantly greater viral suppression after 12 weeks of treatment compared to retreatment with ribavirin plus pegylated interferon in chronic Hepatitis C, genotype 1 patients who were non- responders to previous therapy. Valopicitabine, a novel polymerase inhibitor, is being developed by Idenix Pharmaceuticals Inc. a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral and other infectious diseases.

Dr. Christopher O'Brien, professor of clinical medicine at the University of Miami and a principal investigator in an ongoing Phase IIb clinical trial of valopicitabine, presented 12-week data from this Phase IIb clinical trial on, November 14, 2005 at the 56th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) held in San Francisco.

"At 12 weeks, the combination of valopicitabine plus Pegasys produced a statistically significant improvement in suppression of Hepatitis C virus (HCV) replication and a significantly higher proportion of patients achieving an early virologic response (EVR) compared to patients retreated with Pegasys and ribavirin," said Dr. O'Brien. "These are promising results, particularly for the many treatment-refractory patients in urgent need of new therapeutic options."

The Phase IIb clinical trial in treatment-refractory patients is designed to evaluate different dosing regimens of valopicitabine in combination with pegylated interferon and to compare this combination with the combination therapy of pegylated interferon plus ribavirin. At 12 weeks of treatment, the two higher-dose arms of valopicitabine plus Pegasys showed significantly greater suppression of serum HCV RNA compared to the ribavirin plus Pegasys retreatment arm, states a company release.

"These encouraging data support continued evaluation of combination treatment with valopicitabine and pegylated interferon in both treatment- refractory and treatment-naive Hepatitis C patients. We look forward to initiating our Phase III programme for valopicitabine in treatment-refractory patients in early 2006," said Nathaniel Brown, executive vice president of clinical development and chief medical officer of Idenix

In the Phase IIb clinical trial, valopicitabine has demonstrated satisfactory safety and tolerance overall. A low percentage of patients on valopicitabine have discontinued due to adverse events. Two serious adverse events were considered attributable to combination treatment with valopicitabine plus pegylated interferon (anaemia and dehydration) and both resolved. To date, there has been no predominant treatment-limiting adverse event or laboratory abnormality observed for combination treatment with valopicitabine and pegylated interferon.

At the end of November, Idenix anticipates reviewing with the FDA the available data from the valopicitabine clinical development programme, including data from this Phase IIb clinical trial during an end-of-Phase II meeting.

Valopicitabine, which is administered orally once a day, is intended to block HCV replication by specifically inhibiting the HCV RNA polymerase, the enzyme that makes new copies of the HCV viral chromosome inside infected cells.

Hepatitis C is an infectious liver disease caused by the hepatitis C virus. The World Health Organisation estimates that 170 million individuals worldwide carry chronic HCV infection, with 3 to 4 million new infections occurring globally each year. It is the most common chronic blood-borne infection in the United States.

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Hepatitis C Patients Fare Better with Pegasys(R) - Study from Poland Shows Significant Difference in Efficacy between Leading Treatments
SourceURL:http://www.itnews.it

WARSAW, Poland, November 15 /PRNewswire/ -- Early results from a new study comparing the efficacy of the two leading hepatitis C treatments suggests that patients may increase their chance of a cure by more than 10% if they are treated with PEGASYS(R) and COPEGUS(R) combination therapy. The study, presented today at the 56th Annual Meeting of the American Association for the Study of Liver Diseases, is one of the first scientifically rigorous research efforts comparing leading treatments to determine which provides the best solution for patients battling hepatitis C [1].

"Patients and the medical community are understandably anxious to have reliable information regarding what treatment is most likely to provide a cure for hepatitis C," said Dr Andrzej Horban, from Infection Disease Hospital in Warsaw who headed the study. "My colleagues and I wished to undertake a study that would clearly answer this question and use a methodology that would inspire confidence in the results."

To date, there have been a number of comparative studies undertaken, but few if any, have generated results which reflect best practices in clinical research. In fact, a number of studies promoted to the public have been retrospective analyses of small research efforts that were designed to address different research questions altogether.

More PEGASYS Patients Respond After Only 12 Weeks of Treatment
The study was undertaken in Poland and involved more than 200 people infected with hepatitis C. All patients were assigned to be treated with either PEGASYS combination therapy or Peg Intron(R) combination therapy. After 12 weeks of treatment, 85% of the PEGASYS patients were responding to therapy as compared to only 74% of the Peg Intron patients. Response to therapy at 12 weeks (defined as either a significant drop in viral load or eliminating the virus completely) is typically an excellent indicator that a patient will be cured of the disease upon completing the full course of therapy.

Local Patient Groups Respond with Enthusiasm
Mr Jaroslaw Chojnacki - The chairman of the Prometeusze Community - said: "although we are still awaiting the final results of this study, the patient community is very pleased that this study has been undertaken in Poland. The results of this study can help infected people a lot. If we are convinced that someone's odds of beating this disease are increased by 10% because they took this drug, it would be important information for us", he said.

Like many countries in Europe, Poland is actively addressing the potential time bomb that is hepatitis C. Official figures state 1.5% of the population may have the virus. However patient groups and treating doctors believe that the figure is much higher.

Reference:

[1] Berak, H et al. "Randomized, Open Label Trial Comparing efficacy and safety of pegylated interferon alfa 2a vs 2b treatment of patients with chronic hepatitis infected with non 2/3 genetypes - 12 week virological response" Presented at AASLD, 2005.

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November 16th, 2005


SciClone Announces Data Presentations at AASLD Regarding ZADAXIN's Activity in Hepatitis B
SourceURL:http://biz.yahoo.com

SAN MATEO, CA--(MARKET WIRE)--Nov 16, 2005 -- SciClone Pharmaceuticals (NasdaqNM:SCLN - News) today announced abstract presentations of pre-clinical and clinical data from two separate studies evaluating the activity of ZADAXIN®, also known as thymosin alpha 1, against the hepatitis B virus (HBV). These abstracts were presented during the annual conference of the American Association for the Study of Liver Diseases (AASLD) in San Francisco, California.

Clinical results were presented from a retrospective study evaluating ZADAXIN's effect on complete response depending upon the genotype, or strain, of HBV infection. This study was conducted by Dr. Yun-Fan Liaw of Chang Gung Memorial Hospital and University in Keelung, Taiwan. Results from this analysis indicate that therapy with ZADAXIN led to a higher response rate in HBV patients infected with genotype B than it did for HBV patients infected with genotype C. This conclusion suggests that the likelihood a patient has of achieving a complete response following ZADAXIN therapy could be predicted if the patient is infected with either HBV genotype B or HBV genotype C.

Pre-clinical results were presented from a study evaluating the effect of ZADAXIN on the production of T helper 1 (Th1) and T helper 2 (Th2) cytokines in white blood cells from e-antigen negative HBV patients. This study was conducted in the laboratory of Dr. Pietro Andreone of the Department of Internal Medicine and Hepatology at the University of Bologna in Bologna, Italy. Results from this study show that ZADAXIN induces a significant increase in the production of Th1 cytokines while simultaneously causing a decrease in the production of Th2 cytokines, which are often associated with persistence of infection. Conversely, interferon alpha alone did not modify the production of Th1 cytokines and led to an increase in the production of Th2 cytokines. Furthermore, ZADAXIN and interferon alpha in combination produced a synergistic effect on the production of Th1 cytokines and reversed the stimulatory effect of interferon alpha on Th2 cytokine production.

About SciClone
SciClone Pharmaceuticals is a biopharmaceutical company engaged in the development of therapeutics to treat life-threatening diseases. SciClone's lead product ZADAXIN is currently being evaluated in two phase 3 hepatitis C clinical trials in the United States and one hepatitis C triple therapy clinical trial in Europe. ZADAXIN also is being evaluated in other late-stage clinical trials for the treatment of hepatitis B and certain cancers. The company's other principal drug development candidate is SCV-07, currently in phase 1 development, which is being evaluated for the treatment of viral and other infectious diseases. For more information about SciClone, visit www.sciclone.com.

Pre-clinical and early clinical data may not be indicative of the results that would be obtained in later stage or larger trials.

Contact:

Corporate information contact:
Becky Horner
Investor Relations
SciClone Pharmaceuticals, Inc.
650-358-3437

Source: SciClone Pharmaceuticals, Inc.

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Hep C Victims' Families Seek Public Inquiry
SourceURL:http://www.redorbit.com

RELATIVES of Hepatitis C victims who died after receiving blood transfusions have launched a legal action to seek a public inquiry into the deaths.

Lawyers acting for the three people yesterday urged a judge to take the unusual step in Scots law of making protective costs orders in the cases - to limit their liability in the event of failure - to let their fight for justice go on.

Aidan O'Neill QC told the Court of Session in Edinburgh:

"They are all quite clear they would not be able to proceed if they were exposed to the risk of having to pay such substantial sums of money."

The court was told that since 1980, 4000 people have been infected with Hepatitis C virus after receiving blood products while under the care of the NHS in Scotland.

Neil Davidson QC, for the Executive, asked Lord Glennie to report the case to a bench of three judges to consider the expenses order if it was to be brought into Scots law. The judge reserved his decision.

Source: Evening Times; Glasgow (UK)

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Xtlbio's Hepatitis C Drug Candidate Succeeds in Trial
SourceURL:http://www.globes.co.il/

One of the two antibodies comprising the company's XTL-6865 was shown to be active in reducing viral levels.

XTL Biopharmaceuticals Ltd. (LSE: XTL; TASE: XTL) presented yesterday data from a pilot Phase I/II clinical trial with Ab68, one of the two antibodies comprising XTLbio's lead Hepatitis C drug candidate -- XTL-6865.

This pilot study was conducted in patients with hepatitis C following liver transplantation. Patients in this study were treated with 20, 40, 80, 120 or 240 mg doses of Ab68. Ab68 was administered once during the transplantation, then up to 3 times during the first 24 hours following the transplantation, then daily during the following 6 days, and then in a decreasing frequency during the following 11 weeks.

During the period of daily dosing (the first 7 days following the transplantation) reduction in viral load from baseline was greater in the two highest dose groups (120 and 240 mg) compared to the placebo group. On day 1 following the transplantation (when Ab68 was administered 3 times) the median reduction in viral load from baseline of the highest dose group (240 mg) was 1-log (90%) greater than the placebo group.

Dr. Thomas Schiano, MD, medical director of adult liver transplantation and director of clinical hepatology at the Recanati/Miller Transplantation Institute at Mount Sinai Medical Center said, "The results presented are very encouraging, as they provide clinical demonstration that Ab68 which is one of the two antibodies comprising XTLbio's lead hepatitis C drug candidate -- XTL-6865 -- has shown activity in reducing viral levels."

The dual antibody product -- XTL-6865 -- is presently in Phase Ia clinical trial in patients with chronic hepatitis C. Results from this trial are expected in the second half of 2006

Established in 1993, XTLbio is engaged in the acquisition, development and commercialization of pharmaceutical products for the treatment of infectious diseases, particularly the prevention and treatment of hepatitis B and C.

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Health Officials Raise Hepatitis C Awareness
SourceURL:http://www.newsreview.info
DANIELLE GILLESPIE, dgillespie@newsreview.info

In the early 1970s, Mike Bunyard decided he wanted to get high on drugs so he poked a needle into his vein.

About 20 years later, in 1992, he discovered that choice