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Week Ending: July 28th , 2007
Alan Franciscus
Editor-in-Chief
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This Issue:
July 22nd, 2007
Tainted Blood
New Statesman (U.K.)
By William Hilderbrandt
Infected blood, the American filmmaker, and allegations of a government cover-up.
William Hilderbrandt reports from the Archer Inquiry.
Kelly Duda spent eight years of his life making a documentary chronicling how thousands of people around the world were negligently infected with HIV and viral hepatitis from blood transfusions. The American filmmaker was in Westminster telling his story to the independent inquiry that aims to uncover the British government's part in a scandal that led to thousands of infections and deaths.
In the 1970s the British government began importing blood products in part sourced from American prisons in an attempt to cut costs and to tap into a larger blood bank.
However, patients were not informed of where the blood was coming from and tragically went on being 'treated' with the hepatits or HIV infected samples for more than two decades. Lord Robert Winston has dubbed the tragedy as "the worst treatment disaster in the history of the NHS".
Duda is a bit of a maverick. His flat American accent stood out at the inquiry but not as much as his character. Everything he does is infused with a sense of urgency and speed but juxtaposed by a slightly unnerving smirk. By the time he was done testifying to Lord Archer of Sandwell's Inquiry, those in the audience who weren't familiar with his work had been swayed that the scandal was even worse than they realised - an idea that seemed impossible only one hour earlier.
David Fielding sat in the audience, already familiar with Duda he hoped the film-maker could instill more force into the inquiry. Fielding contracted Hepatitis C from the contaminated blood and his brother, who recently died of AIDS, had contracted HIV. He said Duda helped shine a light on the topic and reveal that it was more than just malpractice: "I don't think my brother was merely a victim. I don't think he just got sick. I think he was murdered."
This sentiment was common in the crowd of victims and family members who heard Duda reveal the origins of the contaminated blood. In his film Factor 8: The Arkansas Prison Blood Scandal, he explains how the Arkansas prison system was able to support itself entirely without taxpayer money and run at a profit due to its plasma programme experimentation.
Doctors harvested large quantities of plasma from inmates – that's despite tthe fact prison populations are considered high-risk populations for disease infection - and sold them to pharmaceutical companies. The prisons made money by selling in such vast quantities, and the drug companies saved by paying far less since the blood was from less than desirable sources.
Duda claimed there was a culture of corruption embedded in the prisons as inmates were in charge of testing the products and had incentive to falsify results and increase prison profits.
Once the samples left the prison, tested or not, they were sent to drug companies. Then the samples were mixed and stirred in large vats before producing various plasma products.
All it takes is one infected sample of HIV or hepatitis to infect the lot. Duda said no one in the chain, from the moment the blood was extracted to when products were injected into patients, made proper efforts to prevent it being administered.
This blood was then shipped around the world - as far as South America and Japan, but throughout Europe as well. In the UK alone nearly 5,000 haemophiliacs contracted Hepatitis C, and 1,200 of these people were also infected with HIV. Nearly a thousand of these infected have already died without the government admitting any wrongdoing or even acknowledging a need to fund a public inquiry.
The victims think a public inquiry is a long-shot but many, it seems, would be happy with an apology and an explanation.
Della Ryness-Hirsch has a son who contracted hepatitis C and wasn't informed about it until years later. She said she knew about the blood being imported and confronted hospital staff about seeking alternative options. The result: across her son's medical record the hospital staff wrote "neurotic mother".
"When you take on the medical establishment you are dealing with the very people who hold your loved one's care in their hands. And that is a very, very frightening situation," she said.
A conspiracy theory has developed among some of the victims that says the government in alliance with the US was looking for guinea pigs to intentionally infect and subsequently use new medicines on. But Duda dismissed this and said the heart of it is greed and financial interest.
"If they were weighing the risk, then they knew the risk. They knew where they were getting the blood from and they knew the samples weren't virally deactivated. They chose commerce over safety."
Still the story has made few ripples in the UK media, and many victims fear the government is waiting for them to die and ignore this four-decade old saga.
But Duda plans to be back. "No one can undo what has happened. All you can do is help inform them as to how and why it happened, and then with that information hopefully shining light on it, it is there for the record so that things like this cannot happen again."
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Liver transplants one step closer
http://www.argusleader.com
By Megan Myers
memyers@argusleader.com
McKennan adds specialist for follow-up care
When a liver transplant brings you back from the brink of death, each new day is a blessing.
"I'm still at the stage where if you hit me with a truck, I'd still have a good day," said Alan Wasserman, who received a new liver last year at the Mayo Clinic in Rochester, Minn.
Making his days even better is the fact that Sioux Falls soon will accommodate Wasserman for follow-up appointments as Avera McKennan builds a liver transplant program of it's own.
It's the next step in McKennan's program, which now performs kidney, pancreas and bone marrow transplants. The goal, officials say, is offering sick patients more opportunities for care closer to home. Now, patients in the region who need liver transplants must travel to Omaha, Rochester, Minneapolis, Denver or elsewhere.
Receiving treatment for liver disease and a transplant can almost be a full-time job for a patient and his or her family, said transplant program director Beth Plahn.
"It can be a real hardship, when you're looking at extended periods of time away from home," she said.
17,000 patiently wait
A variety of conditions can lead to liver failure and the need for a transplant.
Cirrhosis caused by hepatitis C is the leading cause. Cirrhosis occurs when scar tissue builds up in the liver, making the organ unable to do its job of cleaning the blood, storing energy and helping to digest food.
About 580 people are waiting for donor livers in the region that includes the Dakotas, Minnesota, Wisconsin and Illinois, according to the United Network for Organ Sharing. Nearly 17,000 people are on waiting lists nationwide.
"Any additional opportunities for these individuals to get a transplant is really critical and important," said Susan Mau Larson, regional spokeswoman for organ procurement organization LifeSource.
In Wasserman's case, hepatitis C infection led to cirrhosis and then liver cancer. His first indication of cirrhosis came in 2000, when he began spitting up blood.
"I first thought it was a bleeding ulcer," said Wasserman, who works for McKennan's information technology department.
He went first to a gastroenterologist in Sioux Falls and then was referred to Mayo. Doctors there put Wasserman on the waiting list for a transplant.
In late 2005, Wasserman went from sick to much sicker and learned the cirrhosis had led to liver cancer.
"I was dying at that point; the liver was gone," he said. "I wanted to go home and basically curl up in a corner and die."
In March 2006, as Wasserman laid in his hospital bed at Mayo, a donor organ became available. A young man had been killed in a drunken driving accident, and his liver became Wasserman's new lease on life.
"I've got my life back," he said.
Liver doctor
Wasserman plans to see McKennan's new hepatologist, Dr. Narayanan Menon.
Menon, formerly at Mayo, is South Dakota's first hepatologist, and he's an integral part of the creation of the liver transplant program.
After recruiting another full-time hepatologist to join Menon, the program can work to secure liver transplant surgeon Dr. Jeffery Steers, who spearheaded the liver transplant program at Mayo Clinic in Jacksonville, Fla.
Steers already is part of McKennan's existing transplant staff on a part-time, contract basis, Plahn said. Steers wasn't available to comment for this article.
The program also must pass a national certification process.
Landing a surgeon such as Steers would be a major coup for McKennan's program, said Dr. Michael Sorrell, co-founder of the Nebraska Medical Center's adult liver and small bowel transplantation program in Omaha.
McKennan would "have a head up on most programs that start up, for sure," Sorrell said. "If they get an incredibly famous, well-known surgeon, he will generate patients."
The success of any transplant program, Sorrell said, depends heavily on the ability to refer in patients and secure organs, and that probably will be a challenge for McKennan at first.
"That's a bugaboo for all of us," he said. "One of the suppositions when we started the program was that Nebraska was too small a state to sustain a liver transplant program by itself ... unless we could draw regionally and nationally."
Sanford USD Medical Center also entered the transplant business this year with its first kidney transplant. Program director Janet Mize-Jugert said there aren't plans to expand to other organs, but Sanford's focus on growing its pediatric services could lead to a concentration on children's transplant services.
Care closer to home
Some health care providers in the area outside Sioux Falls say having a local liver transplant program and a full-time hepatologist in Sioux Falls will help them better care for their own patients.
"It can be a huge deterrent for a patient to think about having to go four hours away to the closest facility and the expense and lack of family being present," said Tracy Baum, a certified nurse practitioner at the Flandreau Santee Sioux Clinic.
McKennan's policy of providing charity care to patients who can't afford to pay might help some transplant patients, too. That's especially relevant for Native American patients who receive care from the severely underfunded federal Indian Health Service and who need to be transferred out for more critical care, Baum said.
"Many types of services simply aren't available for our patients," she said.
"Transplant is one of those things that can be very, very expensive, and so having the possibility of some procedures and services available for our patients where cost isn't going to be as much of an issue is very important."
Reach Megan Myers at 331-2257.
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Our 10m Hepatitis patients could create an epidemic: experts
http://www.dailytimes.com.pk/
Staff Report
KARACHI: Pakistan is currently home to around 10 to 12 million patients suffering from Hepatitis B and C, Pakistan Society for the Study of Liver Diseases (PSSLD) president, Dr S. M. Wasim Jafri, said Saturday during a press conference to announce the inception of the PSSLD.
There has, however, been no specific countrywide study to determine the prevalence of Hepatitis in Pakistan, Dr Jafri said, and the statistics he quoted are aggregates of separate studies focusing on specific areas. The overall prevalence of the disease in Pakistan, as per these studies, is around 10 to 15 percent, the PSSLD president said, adding that in some areas, such as the Seraiki belt (lower Punjab and upper Sindh), this prevalence increases to around 40 to 50 percent.
Given these high figures, it is imperative that awareness about preventive measures and treatment options be disseminated among the masses, and this, Dr Jafri said, is one of the purposes of the PSSLD. The main objective of the society is to compile appropriate epidemiological data and then delve into the operational phase of the research. Interventions will be organised at various levels to bring about a decrease in the prevalence of the disease in Pakistan. The other major objective of the PSSLD is to develop awareness programmes focussing on the “end users” (people living in areas with a high prevalence of various strains of Hepatitis). The purpose of these programmes would be to sensitise the public, and to develop appropriate guidelines to help people manage different types of Hepatitis.
The PSSLD will also collaborate with professionals in the country, as well as counterparts from other SAARC countries. The society is also organising World Hepatitis Day in Pakistan on July 28. Among the programmes organised for this day is a day-long workshop which will be held at 10:00 a.m. at the Aga Khan University auditorium.
“Our own research, along with those of other practitioners shows that there is a large pool of 10 to 15 million Hepatitis patients in Pakistan. These patients will infect others around them, initiating a vicious circle of disease of epidemical proportions,” Dr Jafri said.
Hepatitis B and C are usually transmitted through sexual intercourse, transfusion of unscreened blood, unsterilized surgical instruments, and the reuse of old syringes, doctors at the press conference said. Hepatitis A and E, on the other hand, are transmitted through food and contaminated water. “People need to understand the difference here, and they need to realise that Hepatitis is not only transmitted through ‘dirty water’,” PSSLD treasurer, Dr Ashfaq Ahmed, said. “We find instances of Hepatitis A and E even in more affluent countries. In Pakistan, we have entire epidemics.”
The government has recently incorporated Hepatitis vaccination in the EPI programme, which is a notable step, doctors said. “There’s a vaccination course for Hepatitis, comprising three injections which should be administered at birth. Also, pregnant women should be screened for Hepatitis B. If the mother has Hepatitis B, the child should be given an immunoglobulin at birth in order to prevent infection,” they said.
Early detection of the disease also increases the probability of complete recovery. No one can claim, however, that the patient will absolutely be cured; there are a lot of factors which count here,” Dr Jafri said.
Other factors which make people more susceptible to the disease are marriages within the family, crowded living conditions, and a non-existent infrastructure for health, especially in feudal areas such as the Seraiki belt. “The incidence of Hepatitis in those regions is around 40 to 50 percent now. It could increase to 70 or 80 percent in the future. The situation is bound to get worse if action is not taken,” Dr Jafri said.
The transmission methods for Hepatitis B, C and D are very similar to those for HIV/AIDS, doctors said in reply to a question. “One strategy would be to add a list of these diseases to HIV/AIDS advertisements printed by the government. Money is being spent anyway on these ads. They can capitalise on it by adding Hepatitis B, C and D in there too, since the methods of transmission are very similar,” PSSLD general secretary, Prof. Saeed Hamid said. “Other strategies would be to involve the indigenous press. What we’ve discovered through our studies is that people in general, even in remote areas, are very concerned about their health. Everyone knows what ‘kaala yarqaan’ and ‘peela yarqaan’ is. So we’ve reached that stage. The next step would be to educate them about what to do: treatment options, etc.”
This raised a question about the cost of the treatment, and the lack of knowledge among general practitioners. Workshops should be held for this, doctors at the press conference said. “The PSSLD has conducted a number of workshops for doctors from around the country. Two were held this year alone,” they said. There were follow-ups through email, etc. There has, however, been no assessment of ethical practices among the participants of these workshops, they conceded. “But our teams have a general know-how about the participants, and they know that most of the participants conform to ethical practices,” Dr Hamid said.
“I was recently invited to a seminar held in Islamabad under the Prime Minister’s Programme on the Prevention of Hepatitis. We made a number of suggestions about team management, disease prevention, etc,” Dr Jafri said. “We’re hopeful that these suggestions will be incorporated into the implementation strategy of the programme.”
The PM’s programme has been on for approximately two years, however, and Dr Jafri was asked about his assessment of it. “It is not possible to rate it right now,” he replied. “Treatment for Hepatitis takes six months to a year, generally – longer for different strains. Follow-up checks have to be maintained for a number of years after the treatment is complete. I will probably get to know about the results five years after the programme was started. There is no question, however, that the programme will not be successful. It was started when we didn’t have any other programmes for Hepatitis, so there has to be some level of success. The amount of success – mild, low, high, etc – is yet to be seen, though.”
There are less than 100 hepatologists (liver specialists) in Pakistan, Dr Jafri said. If gastroenterologists are added to this, the number goes beyond 500. Eighty percent of the PSSLD is made up of doctors working in the government sector. A high level of interaction between the State and private practices is therefore expected, leading to higher chances of success, the PSSLD president said.
Doctors quoted the example of Taiwan to prove that Hepatitis B is totally preventable. “Taiwan had the highest prevalence of Hepatitis B (20 percent). Fifteen years ago, a vaccination programme was initiated, and in 2007, the prevalence there is less than one percent. Similar strategies should be used in Pakistan, too,” they said.
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July 23rd, 2007
Arius Begins Anticancer Preclinical Toxicology Program
http://www.therapeuticsdaily.com
Arius Research Inc. has initiated the first study in the formal preclinical toxicology program for its lead anti-CD44 drug candidate, which is under development for the treatment of breast, prostate and liver cancers. Arius expects to file an IND (investigational new drug) application and begin human clinical trials in 2008.
"We have initiated a preclinical dose-finding toxicology study for our CD44 targeting antibody, which will generate important safety data to be included in our application to the FDA for permission to begin studies in cancer patients," said Dr. Susan Hahn, director drug development at Arius. "Previous studies with ARH460-16-2 have clearly demonstrated very potent inhibition of cancer cell growth in a number of test model systems including a type of breast cancer that cannot be treated with currently available antibodies or hormone therapies."
Arius is developing its novel CD44-targeting antibody for the treatment of solid tumours such as breast, prostate and liver cancers. Published research shows that certain cells in a cancer tumour behave differently from the rapidly dividing cells that are killed by standard cancer treatments. These cells survive standard therapies and are suspected of causing the spread of cancer even after patients appear to have responded to conventional treatments. CD44 can be used as a way of identifying these lethal, cancer stem cells and CD44 can also be the target for drugs to kill them and ultimately improve patient survival. CD44 has been shown to identify cancer stem cells in leukemia, breast, prostate, and head and neck cancer.
"This is an exciting time for Arius as we establish the path for bringing our first therapeutic antibody into clinical development," said Dr. Robert Gundel, chief scientific officer of Arius. "A novel antibody that targets cancer stem cells as part of its mechanism of action represents a new approach to cancer treatment with the potential of better efficacy and less toxicity for patients."
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July 24th, 2007
Pegylated Interferon Alfa-2a and Ribavirin Effective in HIV-Positive Patients With Acute Hepatitis C: Presented at IAS
http://www.docguide.com
By Rachel Parratt
SYDNEY, AUSTRALIA -- July 23, 2007 -- At the end of 24 weeks of treatment with pegylated interferon alfa-2a (PEG-IFN) and ribavirin (RBV), 89% of HIV-positive patients with acute hepatitis C achieved viral load <50 copies/mL, researchers reported here at the 4th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention (IAS).
This highly effective response rate was achieved despite a high proportion of patients with the GT1 genotype, in whom treatment for chronic HCV is less than 30% successful, the researchers noted.
The study enrolled 124 patients with acute hepatitis C as part of the Australian Trial in Acute Hepatitis C (ATAHC). ATAHC, funded by the National Institutes of Health, is a prospective cohort study following HCV outcomes in both HIV-negative and -positive individuals in 19 centers around Australia.
HIV-positive patients with acute hepatitis C are less likely to clear HCV spontaneously. Once chronic HCV is established these individuals have poorer treatment outcomes and higher risk of liver disease progression compared with individuals who are only infected with HCV.
In their study, Gail Matthews, MBChB, MRCP, Lecturer, Viral Hepatitis Clinical Research Program, National Centre in HIV Epidemiology and Clinical Research, University of New South Wales, Sydney, Australia, and colleagues administered PEG/RBV for 24 weeks in 18 of the 27 HIV-positive patients coinfected with HCV.
These patients were HCV antibody positive within 6 months of being recruited, and had either a negative HCV antibody test with 2 years of being tested positive, or an episode of hepatitis. Baseline risk factors for acquiring HCV included known HCV positive status of partner for six patients, unknown partner status for five patients, and injecting drug use in seven patients.
By week 4, a negative result for HCV RNA using a quantitative assay was observed in 93% of patients, and a rapid virologic response (<50 c/mL) was achieved in 56% of patients.
At the end of treatment, 89% of patients had an HCV viral load <50 c/mL. Overall, the sustained virologic response rate, defined as negative HCV RNA, was 72%. Dose reduction was only performed in one patient and 78% of patients received more than 80% of injections.
The authors concluded, "Treatment for [acute hepatitis C] in HIV-positive patients is safe and highly effective."
[Presentation title: Pegylated Interferon Alfa-2a (PEG-IFN) + Ribavirin (RBV) in HIV Infected Individuals Within the Australian Trial of Acute Hepatitis C (ATAHC) Achieves End of Treatment Response (ETR) in Over 80% of Individuals. Poster MOPEB045]
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Samaritan Licenses Exclusive Rights to Infectious Disease Compounds From Georgetown University
http://money.cnn.com
LAS VEGAS, July 24, 2007 (PRIME NEWSWIRE) -- Samaritan Pharmaceuticals, Inc. (AMEX:LIV), a developer of innovative drugs, announced today that it has entered into an exclusive license agreement with Georgetown University for "Benzamide Compounds" patent rights to treat HIV and numerous other infectious diseases.
The underlying licensed patent application describes using Benzamide compounds as an innovative new method to treat the HIV virus and other infectious diseases, such as Avian Influenza A, Influenza A & B, and Hepatitis B & C. Under the terms of the agreement, Samaritan will have exclusive worldwide rights to develop, manufacture and commercialize Benzamide compounds in exchange for royalties.
Dr. Janet Greeson, C.E.O. and President of Samaritan stated, "We are especially pleased to cover our Hepatitis C drug with this patent and license. NIH has been studying SP-10T1 for efficacy with Hepatitis C and has discovered it is displaying 96.3% inhibition, in comparison to injectable alpha-interferon's 97%, which is extremely promising for us since SP-10T1 is an oral drug which is considered to provide a substantial benefit over the injectables on the market for Hepatitis C patients."
Samaritan Pharmaceuticals: "Transforming Today's Science Into Tomorrow's Cures..."
Samaritan Pharmaceuticals is a life science company focused on commercializing innovative drugs to relieve the suffering of patients with Alzheimer's, Cancer, Heart disease, and Infectious disease. Samaritan's business strategy is to partner its later stage drugs after Phase II (proof of concept) human studies and has executed its first partnership for its PII, HIV drug SP-01A, with Pharmaplaz, Ireland. The FDA has authorized an investigational new drug (IND) # and a Phase I for its Alzheimer's drug Caprospinol and Samaritan has several other drugs it is advancing to enter (IND) status. In addition, Samaritan's sales arm has acquired the marketing and sales rights to sell ten revenue-generating products in Greece and various Eastern European countries.
Website, http://www.samaritanpharma.com . Please register so we can notify you of upcoming conference calls, news and events.
Disclaimer
The company disclaims any information that is created by an outside party and endorses only information that is communicated by its press releases, filings, and Website. This news release contains forward-looking statements that reflect management's current beliefs about the potential for its drug candidates, science, and technology. However, as with any biopharmaceutical under development, there are significant risks and uncertainties in the process of development and regulatory review. There are no guarantees that products will prove to be commercially successful. For additional information about the factors that affect the company's business, please read the company's latest Form 10-K filed April 13, 2007. The company undertakes no duty to update forward-looking statements.
CONTACT: Samaritan Pharmaceuticals, Inc.
Richard Brown
(702) 735-7001
RichardBrown@SamaritanPharma.com
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Detecting hepatitis C early is important
http://www.theunion.com
By Chuck Jaffee
Lucinda Porter is a clinical coordinator at the research division of Stanford University Medical Center in Palo Alto and lives with the hepatitis C virus, or HCV. She’ll give a talk on how to live with the disease at a hepatitis C support group meeting scheduled for 4 p.m. Wednesday at Sierra Nevada Memorial Hospital, Room 110, of the Outpatient Center. To confirm, call 274-6124. For more information about hepatitis C, visit www.hcvadvocate.org and www.nchepc.org.
Porter answers some questions about the disease.
Q: How would you summarize living with HCV?
A: Being a patient is a vulnerable position. Being sick is scary, and being scared about being sick is awful. A person may have to live with hepatitis C but doesn’t have to live with fear.
Q: You told me you contracted HCV from a blood transfusion but prefer not to tell people how you got it. Why?
A: Many of those with hepatitis C contracted it from injection drug use, so there is a stigma attached to it. I prefer to focus on the virus rather than how people caught the virus.
Q: Can HCV be life-threatening?
A: Yes, if it progresses. However, the vast majority of those with hepatitis C will not die because of it.
Q: What does the virus do to people?`
A: It attacks the liver. Many of the 5 million people in this country don’t know they have HCV and find out late in the game that the virus is harming their livers. If they are diagnosed, they can avoid or delay cirrhosis of the liver. They can also prevent spreading it to others.
Q: How does a person get HCV?
A: Blood-to-blood contact with HCV-positive blood. Hepatitis C is the most prevalent blood borne virus — one shared needle can give it to you. Other ways are blood transfusions — prior to 1992, and occupationally. It is possible, but rarely, transmitted sexually and during childbirth from a mother with HCV.
Q: Can you get it from the air, doorknobs, casual contact or sex?
A: Essentially, it’s only through blood-to-blood contact and certainly not through kissing or any kind of casual contact.
Q: Can you get it from alcohol or drugs or smoking?
A: It is especially important to stay away from these things if you already have HCV, but these behaviors do not give a person hepatitis C unless they are sharing the needles and drugs with someone who has HCV.
Q: What are the most important things a person with HCV should tend to?
A: Be informed. Don’t give it to anyone else. Take care of your liver. Don’t drink alcohol. Get hepatitis A and B vaccines.
Q: What would you say is the most significant advance that helps people with hepatitis C?
A: When I first joined this field, treatment was hard and had a low success rate. The good news is that the success rate is up to about 50 percent and is more manageable. The bad news is that the success rate is still only about 50 percent.
Q: What is the treatment and what are the side effects of treatment?
A: Treatment, which includes self-injection combined with pills, typically goes on for almost a year. Most people tolerate it, but do suffer a bunch of side effects at various times: Fatigue; depression; dry mouth, skin, and eyes; head, muscle and joint aches. Worse are psychological changes including moodiness, irritability and decreased concentration. Whether people seek treatment or not, detecting the virus early and doing something about it is the best way to minimize the burden of hepatitis C.
Q: You’ve been working with communities to raise awareness for many years. What is your biggest satisfaction?
A: Seeing others regain their courage and start living again.
Chuck Jaffee lives in NevadaCity. He conducted this interview with Lucinda Porter, a fellow member of Sierra Writers (www.sierrawriters.org).
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Naomi Judd shares life story in Pikeville
http://www.news-expressky.com
BY LORETTA TACKETT
STAFF WRITER
“You gotta know where your beliefs come from,” said Naomi Judd, speaking at Pike County Chamber of Commerce's 50th anniversary Friday. “I know where I came from.”
The Kentucky native born Jan. 11, 1946 in Ashland as Diana Ellen Judd shared some of her beliefs with approximately 600 at 74 tables at the Eastern Kentucky Exposition Center.
Her story is one filled with struggles and successes, both fueling the spirit for which Judd is famous.
Diana Ellen Judd got pregnant her senior year of high school and had Wynonna Judd on graduation night, she told chamber guests. On Sunday's episode of “Naomi's New Morning,” appearing at 11 a.m. on the Hallmark Channel, she told guests her school - like most in Kentucky at that time - wanted the pregnant teenager to leave school.
“They didn't want me to be a bad example,” Judd said.
Judd moved to Hollywood and was living on Sunset Street at age 24 with two babies - her future singing partner Wynonna Judd and actress Ashley Judd - and could barely keep a jar of peanut butter on the table with her minimum wage job, she told chamber guests.
Married to a man she didn't love, and trying to raise two girls, Judd said she learned her brother died and her parents divorced within a short period of time.
After getting a restraining order against her “ex-con” husband who was a heroine addict, Judd said she went to a cheap hotel where the clerk was kind enough to give her a room.
“My face was so grotesque,” Judd said about the results of her last incidence as a victim of domestic violence, adding she asked herself, “What are you doing in Hollywood?
“That's how you figure out what your values are. You're not gonna get what you don't think you deserve.
“I packed my stuff and moved to Kentucky. Kentucky saved my life once again.”
An excerpt from her latest book, “Naomi's Guide to Aging Gratefully,” reveals Judd changed her name after she moved from Hollywood and became a nurse. Naomi was the name of a “slow and unlovely girl” Judd went to school with at Crabbe Grade School in Ashland, a girl Judd says, like her, “did nothing to earn the looks and IQ with which she was born.”
“Looking back, this early decision to change my first name in recognition of that other Naomi - who still reminds me to be grateful - has helped preserve my sanity,” Naomi wrote.
“My patients didn't care what my face looked like, how old I was, or how much I weighed,” she wrote.
Telling chamber guests she gave 8-year-old Ashley C.S. Lewis' Chronicles of Narnia,” and 12-year-old Wynonna a plastic guitar, Judd said Wynonna picked up the guitar and discovered her passion.
“During the period, I realized I wanted to go to UK Medical School, but I knew I had to stay with Wynonna, so I started singing harmony,” Judd said. “My gig is to support.”
The mother and daughter duo climbed the country charts in the early ‘80s, claiming 20 top 10 hits - 15 of which were number ones - and were undefeated as a duo for eight consecutive years at all three major country music awards shows. Together The Judds won five Grammy awards, while Naomi won her own in 1991 for writing the country song of the year, “Love Can Build a Bridge,” which also became a TV movie about The Judds in 1995.
In 1991, Judd learned she would have to let her daughter pursue a solo career, as she was diagnosed with the potentially fatal liver disease hepatitis C.
“The doctor told me I had three years to live,” Judd said Friday.
The Judds “Farewell” tour was the top grossing act of 1991 and their farewell concert was the most successful music show ever in cable pay-per-view history, according to Wikipedia.
“The reason I'm here today is because I'm from strong stock,” Judd said about being cured of hepatitis C, calling herself a “documented miracle.”
She acts as a spokesperson for the American Liver Foundation, started the Naomi Judd Education and Research Fund in 1991, using her name to raise awareness about the disease and funds for research.
The former domestic violence victim and single mom on welfare is now the mother of two successful daughters and a humanitarian active in groups like Mothers Against Drunk Driving, Women's World Peace Initiative, and the Safe School Summit. She returns home to Ashland every Fourth of July for the Judd's Annual Food Drive to stock the Appalachia Pantry.
On her Web site www.naomijudd.com, Judd says, “I'm not an expert in anything except making mistakes, but I do have a Ph.D in the school of hard knocks. I'm a road scholar and America is my research lab and I'm just a student of human nature.”
Judd attributes her optimism and success to her roots.
“I'm a ninth generation Appalachian,” she told chamber members. “You gotta know where your beliefs come from.
“When you come from a little town like Pikeville or Ashland, you have a sense of belonging and it serves you well.”
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July 25th, 2007
IAS: Hepatitis C clusters reveal international transmission among HIV-positive gay men
www.aidsmap.com
Liz Highleyman
Clusters of acute hepatitis C in the United Kingdom and elsewhere in Europe provide further evidence that sexual transmission is occurring internationally among HIV-positive gay men, researchers reported Tuesday at the Fourth International AIDS Society Conference on HIV Treatment, Pathogenesis and Prevention.
Six years ago, sexual transmission of HCV among gay men was almost completely under the radar, with many physicians believing that it was a very rare occurrence.
Beginning in the early 2000s, however, doctors in large cities in the UK and Europe (including the Netherlands, Germany and France) started seeing outbreaks of acute hepatitis C, mostly among HIV-positive men who have sex with men. There have now been nearly 400 such cases reported in London and Brighton alone, and similar outbreaks have since been observed in Australia and the United States.
As aidsmap has previously reported, these acute HCV infections appear to be sexually transmitted, and have been linked to risk factors including unprotected anal sex, fisting, multiple partners, group sex practices, concurrent sexually transmitted infections, and non-injection recreational drug use.
Given the mobility of gay men between European cities like London, Amsterdam and Berlin, an international group of researchers decided to investigate patterns of HCV transmission in northern Europe.
Mark Danta from the UCL Institute of Hepatology in London and colleagues recruited 190 HIV-positive men who had been diagnosed with acute HCV infection between 2000 and 2006. Of these, 107 were from the UK, 51 were from the Netherlands, 24 were from Germany, and eight were from France.
All were men who have sex with men, with an average age of about 38 years. Between two-thirds and three-quarters of the men in the various countries were taking HAART, and the mean CD4 cell count ranged from about 400 to about 600 cells/mm3.
Using blood samples, the researchers compared parts of the NS5B sequence of the HCV genome and constructed phylogenetic trees to better understand the linkages between these cases.
Phylogenetic testing compares viral gene sequences with a control group in order to determine the likelihood that samples from the study group are related. Although phylogenetic testing is not considered a reliable way to prove that one individual has infected another, it can provide suggestive information about clusters of infection.
Half the men were infected with HCV genotype 1a, followed by genotype 4d (23%), with the remainder distributed between genotypes 3a (7%), 1b (5%), and 2 (2%). Genotype information was not available for 24 men (13%), who were excluded from further analysis. Compared with the overall distribution of HCV genotypes in northern Europe, the proportion with genotype 4 was unusually high.
The phylogenetic analysis revealed ten clusters that together accounted for 88% of all the HCV isolates, ranging in size from three to 36 individuals. Seven of the ten clusters contained sequences from more than one country, and four contained isolates from more than two countries. One of the two genotype 4d clusters -- which comprised 31 men and was the second largest cluster overall -- included samples from all four countries.
The researchers concluded that this phylogenetic analysis reveals a large HCV transmission network among HIV-positive gay men in Europe, and that travel between countries presumably plays an important role in transmission. Further, they noted, international mixing increased with larger cluster size, indicating rapid spread of regional outbreaks to neighbouring countries.
They recommended that national public health agencies should implement targeted prevention strategies, including HCV screening for high-risk HIV-positive men who have sex with men, to reduce the spread of hepatitis C in this population.
During the discussion following the presentation, Greg Dore from Sydney said that researchers were now analysing gene sequences from gay men with acute hepatitis C in Australia. Danta urged American researchers to collaboration as well, in an effort to learn whether outbreaks in these countries may be linked to those in Europe.
Reference
Danta M et al. Evidence of international transmission of HCV in pan-European study of HIV-positive men who have sex with men (MSM). Fourth International AIDS Society Conference on HIV Treatment and Pathogenesis, Sydney, abstract TUAB201, 2007.
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Discounting InterMune
http://www.fool.com/
By Brian Lawler
With the dearth of data that drugmakers release to investors about their compounds, it's understandable that investors can be a little jittery when a drug gets delayed. Shares of InterMune (Nasdaq: ITMN) fell more than 7% yesterday after an analyst predicted possible safety concerns causing a possible delay with the drugmaker's lead drug, hepatitis C drug candidate ITMN-191.
I used "possible" twice because everything the analyst stated in his report was conjecture about the reason why InterMune and partner Roche haven't started the phase 1b pharmacokinetic and efficacy study for ITMN-191 yet.
As recently as the May first-quarter earnings release, InterMune had stated that the phase 1b study would start in the third quarter with study results released in the fourth quarter, possibly at a medical conference in October or November.
There's no word yet on whether InterMune is sticking to this timeline. But even if there is a delay with ITMN-191, it shouldn't be too much of a concern for investors. InterMune has previously stated that it was revising the phase 1b study after learning more about the potency of the drug from the just-completed phase 1a safety study and from knowledge gained from Vertex Pharmaceuticals' (Nasdaq: VRTX) studies with its HCV compound.
Early-stage hepatitis C efficacy clinical trials typically track a small cohort of 30 to 70 patients over a 15-day period to track the initial viral load reductions and pharmacokinetics of the drug candidate at different dosages. With Roche's deep pockets and experience running clinical trials with the second-highest grossing HCV drug, Pegasys, the ITMN-191 phase 1b efficacy study won't have any problems enrolling patients or being completed in a timely manner.
For instance, the initial ITMN-191 phase 1a safety study clinical trial, which was done in 74 healthy volunteers, took less than five months from its initiation in December 2006 to the announcement of its completion in May. I'd be surprised if the phase 1b trial took as long, considering that it will be tested in a much more motivated patient population and the study results won't take long to analyze.
Shares of both InterMune and rival Vertex have lost over a third of their value since their 52-week highs. Investors looking to buy into the next blockbuster class of hepatitis C treatments on the cheap just got their chance.
InterMune and Vertex are Rule Breakers selections. You can check out all our recommendations as well as get access to our message boards and exclusive content with a 30-day free trial.
Fool contributor Brian Lawler owns shares of InterMune, but no other company mentioned in this article. The Fool has a disclosure policy.
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Korean mummies may provide clues to combat hepatitis B
http://www.eurekalert.org
Mummies that have recently been unearthed in South Korea may provide clues on how to combat hepatitis B, according to Prof. Mark Spigelman of the Kuvin Center for the Study of Infectious and Tropical Diseases at the Hebrew University of Jerusalem.
This is the first time that samples of hepatitis B have ever been found on a mummified body. When the virus was discovered in the liver of a 500 year old child, researchers at Dankook University and Seoul National University invited Hebrew University Prof Spigelman to South Korea to verify the findings.
Spigelman and the Liver Unit at Hadassah University Hospital-Ein Kerem in Jerusalem are now part of an international team to conduct research on the mummies, bringing together experts from Dankook University, Seoul National University and University College London.
Spigelman known for his pioneering studies of ancient diseases (palaeoepidemiology) found on mummified bodies from Hungary to Sudan, in his quest to provide answers to the development of diseases affecting us today, such as tuberculosis, leishmania and influenza. The South Korean mummies are particularly well preserved, and could provide crucial information in the evolution of the hepatitis B virus.
An international killer
Hepatitis B causes liver problems and can lead to liver cancer or liver failure, killing approximately one million people each year.
In South Korea, the need to manage the virus is particularly significant, as twelve percent of the population are hepatitis carriers (compared with a world average of five percent). In China, the virus is one of the leading causes of cancer.
Korean mummies?
Until recently, no one even knew that mummies existed in Korea. Korea's ancient tradition of ancestor worship and the belief that at death, the soul rises up and the body has to go back to its natural components, without interference by external elements, meant that mummification was in fact anathema in Korean culture. However, with the take-over of the neo-Confucianist Joseon Dynasty in 1392, changes were made to the former Buddhist burial practices.
The burial process involved laying the body on ice for three to thirty days during mourning, placing the body inside an inner and an outer pine coffin, surrounded by the deceased's clothes, and the covering he coffin in a lime soil mixture. "In some cases, this inadvertently resulted in extremely good natural mummification," says Spigelman.
The building boom in South Korea has meant that many cemeteries have had to be relocated. It is this process which led to the discovery of the mummified bodies.
Know your enemy
The researchers intend to study the genome of the 500 year old virus to see if there have been any significant changes over this time. Spigelman asks: "Five hundred years ago, was it hepatitis B" Could it be that later on, it split from 'X' and became A and B" Was it already evolved" That's what we don't know."
"This is a 'know your enemy' expedition to see if we can get information that can help today's - and tomorrow’s - sufferers," says Spigelman. He believes that knowing what a virus did 500 years ago helps us understand what it will do as it continues to evolve, and will ultimately alter the practice of public health officials in combating it.
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Father-to-child hepatitis B transmission reported
http://news.yahoo.com
NEW YORK (Reuters Health) - Molecular evidence indicates that father-to-child transmission is an "important route" of hepatitis B virus (HBV) infection in Japan, Japanese researchers warn in the Journal of Medical Virology.
"At present, only high-risk infants born to chronic HBV-infected mothers are given HBV vaccine," note Dr. Hitoshi Tajiri, of Osaka General Medical Center, and colleagues. The investigators say their report provides "substantial evidence" that fathers can and often do transmit HBV to their children.
Performing a number of genetic analyses, including analyses of two coding regions (S and X gene) of the HBV genetic structure, Tajiri's group showed that eight children from five families contracted HBV from their fathers.
The genetic similarity of the five sets of fathers and children was "quite high," between 99.3 percent and 100 percent, they report. Further examination revealed that "all five sets of fathers and children were grouped into the same cluster."
Based on their findings, Tajiri and colleagues "strongly" recommend that Japan's public health agencies "re-examine the current policy of prevention of HBV transmission for children as soon as possible so that universal vaccination against HBV infection is immediately instituted in Japan for all children, as WHO has recommended."
It's also "intriguing," they note, that all of the mothers from the five families studied seemed to have contracted HBV infection, most likely via sexual relations with their husbands, and were cured.
All of them were negative for hepatitis B surface antigen and positive for anti-HBV antibodies, indicating they did not have HBV infection but were previously exposed to the virus.
This suggests that "spouses of HBV-infected husbands should also be protected against HBV infection," the investigators write.
SOURCE: Journal of Medical Virology, July 2007.
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Vertex Shares Rise on Telaprevir Outlook
http://www.forbes.com
NEW YORK - Vertex Pharmaceuticals Inc. shares jumped Wednesday as Wall Street kept a positive outlook on the company's developing hepatitis C drug, despite a wider second-quarter loss.
The stock gained $2.64, or 8.9 percent, to reach $32.36 in afternoon trading. Shares have traded between $25.61 and $45.38 over the last 52 weeks.
Late Tuesday, the company said it lost 91 cents per share during the second quarter, or 74 cents per share excluding one-time charges. Wall Street expected a loss of 69 cents per share. Vertex said the wider loss was mostly due to an increase in costs for midstage studies of telaprevir, aimed at treating hepatitis C.
Bear Stearns (nyse: BSC - news - people ) analyst Samad Akhtar reaffirmed a "Peer Perform" rating, saying recent study data on the relapse rate of patients compared favorably to treatments already on the market.
"While we are encouraged by the low relapse rate seen thus far," he said, "we await further clarity on the outcome of the discussions with the Food and Drug Administration regarding the design of the Phase III clinical trial."
Deutsche Bank (nyse: DB - news - people )-North America analyst Jennifer Chao reaffirmed a "Buy" rating but lowered her price target to $35 from $53. She said interim study data was generally consistent with previous data and said the drug candidate has "blockbuster" potential, meaning it could eventually have annual sales of more than $1 billion if approved.
JP Morgan analyst Richard Smith reaffirmed a "Overweight" rating, say telaprevir is on track to enter a late-stage clinical trial by the end of the year. CIBC World Markets analyst Dr. Brian Abrahams also took a positive outlook on the drug's prospects, reaffirming a "Overweight" rating for the company.
The company has scheduled a meeting with the FDA to discuss the protocols for the Phase III clinical trial.
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July 26th, 2007
Hepatitis C helicase unwinds DNA in a spring-loaded, 3-step process
http://www.eurekalert.org
Using single-molecule fluorescence analysis, Institute for Genomic Biology professor Sua Myong and physics professor Taekjip Ha led a team that discovered the mechanism by which the hepatitis C helicase unwinds...
The process by which genes are duplicated is mysterious and complex, involving a cast of characters with diverse talents and the ability to play well with others in extremely close quarters. A key player on this stage is an enzyme called a helicase. Its job is to unwind the tightly coiled chain of nucleic acids – the DNA or RNA molecule that spells out the organism’s genetic code – so that another enzyme, a polymerase, can faithfully copy each nucleotide in the code.
Researchers at the University of Illinois, Yale University and the Howard Hughes Medical Institute have shed new light on how the Hepatitis C helicase plays this role, using a technique developed at Illinois that can track how a single molecule of RNA or DNA unwinds. Their research findings appear tomorrow in the journal, Science.
Getting at the underlying mechanisms of replication is no easy task. Structural studies involve crystallizing the DNA-protein complexes to see how they interact. Biochemists look at the agents of a reaction, the energy used and how much time lapses between steps. Such studies measure the behavior of hundreds of thousands of molecules at a time, and the results describe a whole population of reactions.
Using single-molecule fluorescence analysis, the research team tracked how the hepatitis C helicase, NS3, unwound a duplexed DNA molecule tagged with a fluorescent label on each strand of its double-stranded region. (The NS3 helicase is primarily involved in unwinding the single-stranded RNA of the hepatitis virus, but it can also act on DNA. This suggests that the helicase plays a role in unwinding double-stranded host DNA during infection. The duplex created for the experiment included both single- and double-stranded DNA; fluorescent labels were located in the double-stranded region.)
By tracking the gradually increasing distance between the two marked nucleotides as the strands separated in an unwinding event, the researchers were able to measure the rate at which the unwinding occurred. What they found was that the DNA unwound in discrete jumps: Three nucleotide pairs (base pairs) had to be unhitched from one another before an unwinding event occurred.
“It’s like you’re adding tension to a spring,” said U. of I. physics professor Taekjip Ha, a researcher on the study and an affiliate of the Institute for Genomic Biology and the Howard Hughes Medical Institute. “You are loading the spring with small mechanical movements until finally you have accumulated enough tension on the DNA-protein complex to cause the rapid unwinding of three base pairs.”
Such reactions are energetically intensive, requiring the input of adenosine triphosphate (ATP) a cellular fuel source. The researchers observed that three ATP molecules were consumed in each unwinding reaction, indicating that three “hidden steps,” each involving the unhitching of one base pair, occurred for each unwinding event.
Although one molecule of ATP contains enough energy to unwind as many as 10 base pairs, the researchers said they were not surprised by the high-energy costs of the reaction.
“Helicases work hand in hand with polymerases in replication, so it makes sense that the helicase would work on one base pair at a time,” said Institute for Genomic Biology professor Sua Myong, lead author on the study. “It’s a very systematic, one-base-pair translocation that may help the polymerase accurately copy genes one base at a time.”
The helicase must also navigate around a lot of obstacles: proteins and other co-factors that are involved in replication. This requires extra energy. Ha compared the energy needs of the NS3 helicase to those of a sport utility vehicle.
“It’s not fuel efficient but in principle it could also go off-road, carry some luggage or maneuver around barriers,” he said. “So it may actually make sense to develop a low-efficiency motor because then you have extra energy to do extra work when needed.”
Myong noted that NS3 is the only helicase in the viral genome, and that it is already being targeted in pharmaceutical studies to combat Hepatitis C infection. It also belongs to the largest of four helicase superfamilies, so the new findings could have relevance across many organisms.
###
Funding for this research was provided by the National Institute of General Medical Sciences at the National Institutes of Health.
Editor’s note: To reach Sua Myong, e-mail: smyong@uiuc.edu.
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Development Discontinued for ANA975, an Early Stage Compound for Treatment of Hepatitis C Virus Infection
http://biz.yahoo.com
Conference Call Scheduled for Friday, July 27 at 8:30am EDT
SAN DIEGO, July 26 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS - News) today announced that it and Novartis have decided to discontinue the development of ANA975, a phase 1b compound for the treatment of hepatitis C virus (HCV) infection. The parties have determined that the results received to date from the ongoing 13 week toxicology study together with the results observed in the previous 13 week toxicology study do not support further clinical evaluation of chronic daily dosing of ANA975 in hepatitis C patients.
"Although we are disappointed to discontinue development of ANA975, our animal toxicology results have convinced us that chronic daily dosing of this compound is inappropriate for further clinical development," said Lawrence C. Fritz, Ph.D., president and chief executive officer of Anadys. "However, we remain optimistic that TLR7 agonists offer therapeutic potential as effective immunomodulators in multiple disease areas, albeit using alternative dosing schedules, and our plans to develop ANA773 for cancer treatment continue unabated," Dr. Fritz said.
Anadys continues its development of ANA773, another TLR7 agonist prodrug distinct from ANA975, and expects to file an IND by the end of 2007. Anadys plans to evaluate ANA773 in Phase 1 clinical trials for the treatment of advanced cancer. This program is independent of the Novartis collaboration and is not affected by the decision to discontinue development of ANA975.
First and Second Toxicology Study Results
In June 2006, Anadys and Novartis suspended dosing in their 28-day phase 1b clinical trial of ANA975 in HCV infected patients due to then recently obtained information from pre-clinical 13-week toxicology studies. No clinical observations contributed to this decision. Preliminary analysis of the toxicology information revealed various new observations which appeared consistent with intense immune stimulation in animals. Subsequently, the FDA put the ANA975 IND on full clinical hold. In November 2006, Anadys and Novartis initiated a second 13-week toxicology study to understand better the observations from the first toxicology study and to assist in determining a future course of action for the program.
Analysis of available data from the second 13-week toxicology study, together with the results from the initial 13-week toxicology study led the parties to determine that: 1) chronic daily dosing of ANA975 was unlikely to provide an adequate therapeutic index; and 2) additional preclinical evaluation would be necessary to determine if alternate dosing schedules of ANA975 would support a safety margin sufficient for further development of this compound for the treatment of patients chronically infected with hepatitis C.
About TLR-7
Toll-like receptor 7 (TLR7) is a pattern-recognition receptor that activates the innate immune response. Stimulation of TLR7 induces the release of interferon-alpha and other type I interferons from immune cells, the release of various pro-inflammatory cytokines, the upregulation of co-stimulatory molecules and the development of an adaptive immune response. Small-molecule TLR7 agonists have been shown to have broad antiviral and anticancer effects in preclinical models and in some clinical settings.
Webcast of Conference Call
Anadys will host a conference call tomorrow at 8:30 a.m. Eastern Daylight Time to discuss the discontinuation of ANA975 development in HCV. A live webcast of the call is available online at http://www.anadyspharma.com. A telephone replay will also be available approximately one hour after completion of the call. To access the telephone replay, dial 888-286-8010 (domestic) or 617-801-6888 (international), passcode 38857175. The webcast and telephone replay will be available through August 10, 2007.
About Anadys
Anadys Pharmaceuticals, Inc., http://www.anadyspharma.com , is a biopharmaceutical company committed to advancing patient care by discovering, developing and commercializing novel small molecule medicines for the treatment of viral diseases and cancer. The Company's programs focus on Toll-Like Receptor-based small molecule product candidates and direct antiviral compounds that inhibit key steps in viral proliferation. The Company has core expertise in medicinal chemistry coupled with cell biology and structure-based drug design, and is developing compounds for the treatment of hepatitis C infection, hepatitis B infection and cancer.
SafeHarbor Language
Statements in this press release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, references to the belief that TLR7 agonists offer therapeutic potential as effective immunomodulators in multiple disease areas, the believed effect of using alternate dosing schedules, as well as the timing and plans for filing an IND for ANA773 and pursuing development activities with ANA773 in advanced cancer. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause Anadys' actual results to be materially different from historical results or from any results expressed or implied by such forward- looking statements. In particular, the results of in vitro studies and initial in vivo studies may not be predictive of future results, and Anadys cannot provide any assurances that any of its product candidates will not have unforeseen safety issues, will have favorable results in future clinical trials or will receive regulatory approval. In addition, Anadys' results may be affected by other factors. In particular, there is no guarantee regarding Anadys' future involvement with, or value recognition from, the ANA380 program. Anadys' results may be further affected by risks related to its collaborative relationships with Novartis and LG Life Sciences, competition from other biotechnology and pharmaceutical companies, its effectiveness at managing its financial resources, its ability to successfully develop and market products, the level of effort that its collaborative partners devote to development and commercialization of its product candidates, difficulties or delays in its pre-clinical studies or clinical trials, difficulties or delays in manufacturing its clinical trials materials, the scope and validity of patent protection for its products, regulatory developments involving future products and its ability to obtain additional funding to support its operations. Risk factors that may cause actual results to differ are more fully discussed in Anadys' SEC filings, including Anadys' Form 10-K for the year ended December 31, 2006 and the "Risk Factors" section of Anadys' Form 10-Q for the quarter ended March 31, 2007. All forward-looking statements are qualified in their entirety by this cautionary statement. Anadys is providing this information as of this date and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
Source: Anadys Pharmaceuticals, Inc.
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Biolex Therapeutics Announces Positive Phase 2a Results for Hepatitis C Product Candidate Locteron(TM)
http://biz.yahoo.com
PITTSBORO, NC--(MARKET WIRE)--Jul 26, 2007 -- Biolex Therapeutics today announced successful initial results from the SELECT-1 Phase 2a clinical trial of Locteron(TM), the first controlled-release interferon alfa being developed for the treatment of chronic hepatitis C. In the 12-week Phase 2a trial, the combination of the highest dose of Locteron evaluated and the antiviral drug ribavirin achieved an early virologic response (EVR) in 100% of the hepatitis C patients treated. Importantly, the study results also indicated that patients receiving Locteron experienced side effects that were less frequent and less severe than those previously reported in clinical trials for the currently marketed pegylated interferons and for albumin-fused interferon (Albuferon(TM)) currently under development. Biolex is co-developing Locteron with its partner OctoPlus N.V.
SELECT-1 (Safety and Efficacy of Locteron: European Clinical Trial-1) was designed to evaluate a range of up to four doses of Locteron administered once every two weeks in combination with ribavirin in a total of 32 treatment-naïve hepatitis C patients with the genotype-1 variant of the virus. The SELECT-1 protocol calls for patients to be treated for 12 weeks with the Locteron/ribavirin combination, and the repeat-dose study will assess viral response, safety and tolerability for each dose cohort. Under the protocol, dosing was commenced in January 2007 for the first three eight-patient cohorts of the study, the 160, 320 and 480 microgram (µg) doses, and dosing of the 640 µg cohort was to be triggered based on an assessment of safety and tolerability for the first three dose cohorts. As a result of a favorable safety and tolerability review for the first three dose cohorts, dosing of patients in the 640 µg cohort commenced in May 2007 and results are expected to be available in the fourth quarter of 2007.
"We are very pleased with the results from SELECT-1 as they support our original hypothesis for Locteron, that a controlled-release interferon alfa has the potential to provide a high level of efficacy while resulting in an improvement in side effects and patient tolerability," said Mr. Jan Turek, Biolex President and Chief Executive Officer. "Even in advance of completion of the highest-dose cohort in the study, SELECT-1 has highlighted two doses that appear to provide a combination of efficacy and improved tolerability. We believe that the need for improved patient tolerability will become even greater with the emergence of new antiviral products. These emerging antiviral products are associated with additional side effects, further adding to the potential for Locteron to be the interferon of choice for future combination therapy as a result of its potential for improved patient tolerability."
SELECT-1 Antiviral Results
The study has been completed for the 160, 320 and 480 µg dose cohorts of the study. The 12-week antiviral results for the two Locteron doses that were most effective, the 320 and 480 µg doses, compare favorably with results previously reported in clinical trials for the currently marketed pegylated interferon alfa products and for Albuferon. At the conclusion of the study, 12 weeks of treatment, the results for the 160, 320 and 480 µg dose cohorts were as follows:
- A dose response was observed in the study, with patients treated with the 320 and 480 µg doses of Locteron demonstrating a greater reduction in hepatitis C virus than the patients treated with the 160 µg dose at all measurement times. Average viral reduction after 12 weeks of treatment for the 320 and 480 µg doses was 4.5 and 4.2 logs, respectively, compared to 1.8 logs in the lowest dose of 160 µg.
- After 12 weeks of treatment, plasma hepatitis C RNA was reduced to undetectable levels ( < 28 IU/ml) in 63% (5/8) and 63% (5/8) of the patients in the 320 and 480 µg dose cohorts, respectively, compared to 13% (1/8) of the patients in the lowest-dose group of 160 µg.
- The percentage of patients who achieved early virologic response (EVR), defined as at least a two-log reduction in hepatitis C virus after 12 weeks of treatment, was 88% (7/8) and 100% (8/8) in the 320 and 480 µg dose cohorts, respectively, compared to 38% (3/8) of the patients in the lowest-dose group of 160 µg. Achievement of EVR has been broadly established to be a pre-requisite for long-term response.
SELECT-1 Safety and Tolerability Results
The following Locteron side effect and patient tolerability results were observed during the 12 weeks of treatment for the 160, 320 and 480 µg dose cohorts:
- Locteron was safe and well tolerated.
- There were no serious adverse events.
- The vast majority (over 90%) of the adverse events that were experienced were rated as mild.
- Dose reductions were limited to one patient each in the 320 and 480 µg dose cohorts with none in the 160 µg dose cohort.
- No patients discontinued treatment.
The majority of the side effects experienced by patients treated with Locteron in the SELECT-1 study in the 160, 320 and 480 µg dose cohorts appear to be less frequent and less severe than the side effects reported in previous clinical trials for pegylated interferons and Albuferon. For example, only one patient in the SELECT-1 study receiving Locteron experienced an adverse event rated as severe, indicating an improvement over previously reported results in clinical trials for Pegasys® and Albuferon as illustrated in Figure 1.
Although many of the side effects experienced by patients in the SELECT-1 trial and clinical trials for other interferon products are subjective in nature, the occurrence of fever is an objective point of comparison and is a marker for the family of adverse events characterized as flu-like symptoms and. Fever, characterized by a temperature reading of at least 38 degreesC, occurred in only one (4%) of the Locteron patients in SELECT-1, notably lower than other interferon products as illustrated in Figure 2.
Furthermore, the rates of other side effects previously reported in clinical trials for pegylated interferons and Albuferon, such as chills, diarrhea, dizziness, headache, irritability, and nausea, also appeared to be lower in patients treated with Locteron in SELECT-1. All other side effects experienced by patients treated with Locteron in SECLECT-1 were predominantly mild and appeared as a group to be comparable with other interferon products.
Locteron Overview
Locteron combines BLX-883, a recombinant interferon alfa produced by Biolex in its patented LEX System(SM), with PolyActive(TM), an advanced controlled-release drug delivery technology developed by OctoPlus. Locteron is the first controlled-release interferon alfa under clinical development for the treatment of hepatitis C and is designed to improve patient care through a more favorable side-effect profile and more convenient patient dosing. Locteron is configured to allow dosing once every two weeks, an improvement in patient convenience compared to currently marketed pegylated interferon alfa products that require dosing every week. More importantly, Locteron's controlled-release mechanism results in the gradual release of interferon alfa to patients over the duration of two weeks. This controlled-release mechanism is designed to cover inter-dose troughs while reducing the frequency, duration and severity of side effects, including flu-like symptoms, commonly experienced by patients treated with currently marketed pegylated interferons and with Albuferon.
Biolex and OctoPlus plan to commence SELECT-2, a Phase 2b trial of Locteron in 2008 after assessment of the final results from the SELECT-1 Phase 2a trial, expected to occur in the fourth quarter of 2007. The 12-week results of the Phase 2b trial will be used as the basis for dose selection for the commencement of the Phase 3 development program.
Locteron is an investigational therapeutic candidate and has not been approved for sale by the United States Food and Drug Administration or by any international regulatory agency.
About Biolex Therapeutics
Biolex Therapeutics is developing and commercializing therapeutic proteins based on its proprietary LEX System(SM), an expression system that enables the commercially viable production of hard-to-make proteins and the optimization of monoclonal antibodies. The Company is developing a proprietary pipeline of biologic product candidates that have known mechanisms of action and have the potential to provide a reduced risk profile while targeting large, proven pharmaceutical markets. Biolex's lead candidate, Locteron(TM), under joint development with OctoPlus N.V., is in Phase 2 clinical development as a controlled-release interferon alfa for the treatment of hepatitis C. The Company's second product candidate, BLX-155, is a direct-acting thrombolytic, designed to break up blood clots in patients with diseases or conditions such as acute peripheral arterial disease, deep vein thrombosis and hemodialysis graft thrombosis. In addition, the potential capabilities of the LEX System has led to collaborations with Centocor, Medarex, Genmab and other leading pharmaceutical and biotech companies. Biolex is a venture capital-backed company located in the Research Triangle region of North Carolina, United States. For additional information, please visit Biolex's web site at www.biolex.com .
Contact:
Media:
Michelle Linn
Linnden Communications
508-419-1555
Investors:
Dale Sander
Chief Financial Officer
858-663-6993
Source: Biolex Therapeutics
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July 27th, 2007
'UNCLE' JOHN TURNER, 1944-2007
http://www.chron.com
By JOEY GUERRA
Musician helped shape the landscape of Texas blues
Drummer "Uncle" John Turner, who helped shape the Texas blues scene, died Thursday in Austin from complications related to hepatitis C. He was 62 years old.
The Port Arthur native was childhood friends with fellow blues icon Johnny Winter. They teamed with bassist Tommy
Shannon for some of Winter's landmark early recordings and played at Woodstock in 1969.
"Uncle John was my dearest friend. He was more than a brother to me," said Shannon. "He's the one who actually talked Johnny Winter into playing blues."
Turner and Shannon moved to Austin in 1970, where they formed Krackerjack, which featured young guitarist Stevie Ray Vaughan.
Through the years, Turner performed with a series of legendary blues and rock acts, including B.B. King, Jimi Hendrix, Freddie King, Muddy Waters and Lightnin' Hopkins.
A benefit for Turner, featuring Sonny Boy Terry, Texas Johnny Brown, the Hightailers and Jerry LaCroix, was held July 22 at Dan Electro's Guitar Bar in Houston. It was meant to raise funds for a liver transplant.
"Uncle John Turner was, to me, the gatekeeper of the blues," said Terry, a Houston-based blues player.
During his days as a struggling harmonica player, Terry said he spent a year rooming with Turner in Houston.
"He really mentored me on Louisiana and Texas blues — all the deep-dish authentic stuff. He was a real mystical cat who I will always love."
A benefit concert Wednesday in Austin will go on as scheduled. Winter and Shannon are scheduled to perform, and profits will be used to offset medical bills and funeral arrangements.
Turner is survived by his wife, Morgan. Memorial services are pending. For more information, visit uncathon.com.
joey.guerra@chron.com
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Many remain untested
http://www.edmontonsun.com
By Jeremy Loome, Edmonton Sun
Some 40% of 2,900 former patients of the Vegreville hospital contacted by the province have yet to be tested despite potential exposure to HIV, Hepatitis B and C and other communicable, deadly diseases.
That led to calls from the opposition parties yesterday for the Alberta government to do more to impress the importance of testing upon the former patients.
Liberal critic Laurie Blakeman went a step further, saying the fact that other residents could be at risk of a communicable disease means the government should make the testing mandatory.
"If the individuals say, 'Leave me alone, I don't want to know if I've got a fatal disease', OK, fine," she said. "But if that person is moving through society and has contact with others, and has a communicable disease, there is a larger onus on government to make sure that person has been notified and that they are able to warn other people in their life."
Meanwhile, a Tory MLA whose committee gave a glowing review of the St. Joseph's Hospital after two separate inspections - despite an outbreak of uncontrolled infectious disease - now says he can't recall the inspection or the glowing review.
But Len Mitzel, the MLA for Cypress - Medicine Hat, vowed to get to the bottom of why the provincial Health Facilities Review Committee not only approved of the operations at St. Joseph's but highlighted allegedly stirling efforts to prevent infections from spreading. That's despite an investigation released Wednesday by the Health Quality Council of Alberta, citing dozens of blatantly obvious infection risks and bungled management practices.
"That doesn't make sense to me at all," said Mitzel. "And I don't have the advantage of having the notes in front of me, and it did 200 reviews a year. This one's not coming up to me at all."
Mitzel suggested, however, that a faulty review wouldn't be his fault, even though he was chair at the time, because the committee isn't involved in the actual on-site review team that goes to each facility.
The committee's current chairman, Drumheller-Stettler MLA Jack Hayden, said he still thinks the Health Facilties Review Committee has merit, even though this is the second embarrassing incident in which it has given a questionably positive review.
Its earlier glowing perspective on Alberta's long-term care system was slammed by the auditor general in 2004, at which time the government was told the committee doesn't have the technical expertise to do its job.
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Obesity 'No. 1 liver issue'
http://www.thestar.com
Joseph Hall
Medical Reporter
Liver Quick Facts
- The liver performs nearly 500 functions in the body, including the production of energy, the elimination of toxins from the blood, infection control and the storage and transportation of iron.
- Hepatitis B and C affect more than half a million Canadians and more than 500 million worldwide. That compares with 50 million who have contracted HIV globally.
- Symptoms of liver disease include jaundiced skin and eyes, dark urine, abdominal swelling and pain, incessant itchiness and nausea, loss of appetite and fatigue
It's been given the chopped liver treatment for far too long now.
The liver, one of the body's most important and vulnerable organs, has languished in relative medical obscurity as hearts, lungs, breasts, bones and a host of viral and genetic diseases have crowded it out for recognition and funding.
But almost one in 10 Canadians will suffer from ailments of the blood-cleansing, energy-producing organ during their lifetimes, according to the Canadian Liver Foundation.
And a new foundation campaign to promote liver health and awareness - through television beer commercial spoofs, among other things - is aiming to bring a growing number of liver problems into the medical and public spotlight.
"Liver disease is poorly understood and receives woefully inadequate public and financial support," said foundation president Gary Fagan.
"We hope that we can make this a top of mind issue for Canadians," he said.
Cancer and heart disease currently receive 10 to 15 times more money each year for research, Fagan estimated.
Yet nearly one in 10 Canadians will face a liver ailment in their lifetimes, he said - a number in keeping with some of the country's most common diseases.
Part of the reason for this, he said, is that liver disease has suffered from the widespread and unsympathetic notion that it is often self-inflicted, with alcohol-induced cirrhosis being the most well-known organ ailment.
But there are more than 100 types of liver disease, only one of which is caused by alcohol abuse, said Fagan.
"There is a stigma and often-times a joke about liver disease. Everybody (including many doctors) who talks about liver disease . . . starts talking about how much you drink," Fagan said.
Yet the most common and fastest growing form of liver ailment - affecting more than 1.4 million Canadians - is related to the growing obesity crisis, Fagan said.
Known as fatty liver disease, it is marked by a buildup of fat in the organ and can be caused by both poor nutrition and exercise habits and by drinking. It is often a precursor to cirrhosis.
But Fagan said the percentage of fatty liver disease caused by obesity has now surpassed the proportion due to alcohol abuse.
"Fatty liver due to obesity has become the number one (liver) health issue," he said.
And liver ailments can strike people of all ages, including infants, with few current available cures outside of transplantation.
Melissa Harris, of Napanee, was 35 weeks pregnant with her first child when she began to suffer from nausia, heartburn, fatigue and swelling back in November, 2006.
Assured, however, that these were commonplace symptoms of a third trimester, she made due with an antacid to take care of her stomach upheavals.
Within a week, she had lost her baby and slipped into a coma - after being diagnosed with a rare ailment known as acute fatty liver pregnancy. The disease, which resembles cirrhosis, affects about one if 15,000 pregnant women and can completely destroy the organ function.
"The doctors asked me did I do drugs or drink and a I said 'of course not'," the 31-year-old schoolteacher now says. "It's just not always related to alcohol."
Harris also said the campaign's goal of prompting doctors to think "liver" in the face of more obvious diagnoses is crucial.
"I would just like to say to people in the medical field . . . if there are these symptoms, do a liver function test," she said.
Harris, who came out of the comma after two weeks, was on the brink of having a liver transplant - with her compatible husband as the scheduled donor. Prior to that early 2007 surgery, however, she began to experience a regeneration of her own organ.
A major problem with liver diseases - one the campaign hopes to address - is that they rarely present themselves symptomatically until huge damage has already been done.
"The heart of the issue is that a lot of people who have liver disease have not been diagnosed with it," Fagan said."The liver is an amazing organ that doesn't always tell someone that they've got a problem."
Fagan said doctors must learn to investigate liver function in a routine way with their patients.
And early intervention can play a crucial role in reducing mortality, as the organ's capacity to regenerate itself is almost miraculous, Fagan said.
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