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Week Ending: September 2nd , 2006
Alan Franciscus
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August 26th, 2006
Transplant Patients Can Wait Lifetime for Donor
http://www.nevadaappeal.com
Ashley Noel Hennefer
Nevada Appeal News Service
Although the number of those awaiting transplants is rising, the number of donors is not.
More than 90,000 people are waiting for an organ transplant. Every 14 minutes another name is added to the National Waiting List - 16 transplant candidates die every day waiting for an organ. One person can help more than 100 people by becoming an organ donor.
Theresa Tierney from Gardnerville knows just how long that wait can be.
Tierney's twin brother Steve Clapham has end stage liver disease as well as Hepatitis C and has been waiting for a liver transplant for about 18 months.
"Steve was told one time that his liver is functioning at 20 percent," Tierney said.
Clapham lives in San Diego and has Flolan, a drug used to treat primary pulmonary hypertension, injected into him all hours of the day. Pulmonary hypertension is what is holding him back from being placed on the wait list. However, once he receives a transplant, he will no longer need to use Flolan.
"At one time we were considering a live donation because we're twins," Tierney said. "But I have children and a family, and I am in excellent health and he didn't want anything to jeopardize that."
The medical field is constantly increasing its knowledge of science and the human body, and organ transplants are becoming more common. Last year, more than 25,000 lives were saved through organ transplants.
A person is placed on the National Waiting List if they have a condition that will lead to organ failure and are recommended by their doctor to receive an organ transplant. They are then sent to a transplant hospital, which has to accept someone in order to be placed on the list. A person can be eligible for multiple lists depending on needs such as age, medical urgency and organ needed.
Sissy Gansberg has seen the other side of the story.
Gansberg, 41, donated her kidney to her brother, Allan Heim, 42, from Novato, Calif., almost two years ago.
"He called me up one day and pretty much told me he was having kidney failure," said Gansberg, a nurse at Carson Tahoe Regional Medical Center.
Heim was diagnosed with auto immune disease, which is when your body rejects an organ in your body, such as the liver. Sissy said the disease may have been a result of strep throat.
Gansberg and her brother weren't sure how long it would take to find out if he needed a transplant or dialysis. However, Gansberg was tested and found to be a match.
Gansberg's husband had a hard time with it at first.
"I told him I really wanted to do it," she said. "We had always talked about if I died that I wanted to donate my organs."
After a series of tests, they discovered that their other sister was also compatible, but because Gansberg is taller her kidney would be larger, and she was chosen. A transplant was officially decided on, and right before Christmas 2004, Gansberg donated her smaller kidney to her brother.
The operation was successful. However, it didn't stop there. She was told it would take around 4-6 weeks to recover, but it ended up taking more than that.
"My muscles hurt, I was achy. It wasn't much fun," she said of her experience. "The recipient recovers much faster than the donor."
Two years have passed, and both Gansberg and her brother are healthy. There have been no signs of the liver being rejected in her brother's body.
"There are so many people who need organs," Gansberg said. "And a lot of people are scared. It's scary having surgery. But I would do it again."
Becoming an organ donor is simple. When you register or renew your driver's license, you have the option of being an organ donor. When you die, your organs would be donated after death has been legally declared. If you agree, a little red heart next to the words "Organ donor" is printed on your license. Also, another way is by telling your doctor.
On the Net
For information on becoming an organ donor, go to:
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Woman Writes Songs for a Cause
http://www.news14charlotte.com
By: Martie Salt, News 14 Carolina
Kelly Zirbes’ nonprofit group tours the country raising money and awareness.
Kelly Zirbes is a singer with big dreams that reach far beyond a hit song. With her song list, she carries a message about an infection affecting more than 4 million people in the United States.
Her goal is to get people tested and comfortable talking openly about Hepatitis C.
"The stigma is unbelievable in this disease and it shouldn't be,” she said. “People who are sick shouldn't be hiding."
Hepatitis C is a liver-damaging virus spread through contaminated blood and body fluids. Although 80 percent of patients have no signs, others suffer from jaundice, fatigue, nausea and stomach pains.
Kelly Zirbes' goal is to get people tested and comfortable talking openly about Hepatitis C.
A close friend's diagnosis inspired Zirbes more than five years ago to get the word out.
"Every time I do something like this, any time I do an event to raise awareness of Hepatitis C, you know I always think of her," she said.
Zirbes lost her friend but continued with the mission. She started a nonprofit to educate more people.
"I get people who say I’ve never told anyone except you and my doctor," she said.
Zirbes’ nonprofit group tours the country raising money and awareness. Every dollar helps pay for the creation of more postcards and T-shirts supporting her Hepatitis C awareness campaign.
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August 27th, 2006
Another Big Tissue Scandal Rocks Field
http://news.yahoo.com
By MARILYNN MARCHIONE, AP Medical Writer
It could have ended three years ago, when a leaky FedEx box containing an arm and legs turned up in Missouri. Or years before that, when a judge convicted him of embezzling money from the sale of a corpse that belonged to a medical school in California.
But nothing stopped Philip Joe Guyett Jr. from moving steadily eastward, mining gold from the lucrative body parts trade. Federal officials shut down this flesh-and-bone prospector in Raleigh, N.C., earlier this month, saying his products posed a danger to public health.
By then, he had supplied hundreds of tissues for knee repairs, spine surgeries and other medical procedures around the nation, many of them allegedly procured in an unsterile funeral home embalming room.
Despite his conviction, he twice was able to register companies with the U.S. Food and Drug Administration to provide tissue for transplants.
"Here's a convicted felon who could pretty much go anywhere in the country and open a tissue recovery agency," complained one tissue banker who refused to work with him, Ken Richardson of Nevada Donor Network. "That illustrates some of the problems with our existing regulatory structure."
Guyett, 38, denies any wrongdoing, and insists he went out of business on his own accord some months back. No one yet knows how many people received tissue he supplied or what risks they may face. Companies have been quietly recalling his products from doctors and hospitals since early July.
Many who work in this field are outraged by the problem, the second big tissue scandal in a year, following one that led to criminal charges in New Jersey. But a three-month investigation by The Associated Press, published in June, found that lax oversight of the billion-dollar industry allows such situations to occur and puts the public at risk.
Donated cadaver tissue is used in more than a million procedures each year, and most of these operations do a lot of good.
But poor testing or treatment can lead to infections like hepatitis — and even death. Oversight is up to the FDA, but it relies on broad-brush rules. The American Association of Tissue Banks has strict standards, but the FDA does not require companies to join or to abide by these rules.
"In this business what really rules is: Do you have the goods? Can you give the body parts that I need? If you have a sketchy background, that doesn't really make a difference. People just want to get the parts," said Annie Cheney, author of the book "Body Brokers."
Time after time, the smooth-talking, affable Guyett found ways to get the goods.
"Our mission," he said when pitching tissue donation to residents of a suburban Raleigh retirement home last year, "is to give donors and their families an informed choice when considering making an anatomical gift." In a video of the May 2005 talk, his audience, which included funeral directors, is seen applauding at times.
How and when Guyett got into the business isn't clear. Parts of the resume he gave the group sponsoring his talk do not match what others say. Like being an anatomy instructor at Mount San Antonio College in Walnut, Calif., from 1997 to 1999. The school has no record of an instructor by that name, said human resources clerk Nerissa Uiagalelei.
The resume also lists Guyett as a "forensic specialist" from 1993 to 1997 in the Clark County, Nev., coroner's office. But that title isn't used at the Las Vegas agency and Guyett only volunteered there some weekends between 1994 and 1996 and was not a paid employee, said Coroner Michael Murphy.
Guyett's "affiliation with our office appears to be exaggerated," he added.
Undisputed, though, is that Guyett was an administrator at the willed body program at Western University in Pomona, Calif., in 1999 when police charged him with selling a cadaver to another school and keeping the $1,100 payment.
He pleaded no contest to a felony, embezzlement; other charges, unlawful removal of human remains and grand theft, were dropped, said Jane Robison, spokeswoman for the Los Angeles County District Attorney's office. He was fined and sentenced in April 2000, performed six months of community service — highway cleanup — and was given three years' probation.
By the fall of 2003, he was in Las Vegas, registering Donor Referral Services with the FDA as a human tissue business. Soon afterward, Missouri police discovered human limbs in a leaky FedEx container Guyett's company had shipped to a Missouri man who provides body parts for medical research and teaching. Much ado about nothing, Guyett told the St. Louis Post-Dispatch.
"Boxes break," the newspaper quoted him as saying. "If a box leaks and it's carrying a cornea, no one freaks."
At the time, Guyett and his second wife, Jennifer, lived in Henderson, a Las Vegas suburb, in a four-bedroom home bought in November 2002 for $258,676.
But business apparently was slow. Officials at virtually every funeral home and crematorium in Las Vegas told the AP they didn't do business with him, or even know him.
By the summer of 2004, Guyett was planning to relocate.
Larry Parker, president of Cremation Society of the Carolinas, a Raleigh funeral home, got a call from Guyett, whom he didn't know, saying he was thinking of moving to be closer to the East Coast tissue banks he worked with.
By November 2004, Guyett had sold the Nevada house, with a profit of nearly $200,000, moved to Raleigh, and was paying Parker $1,000 for each successful donor family he referred and use of his embalming room.
"If they said, 'yes,' that's as far as we went," and Guyett would take over, interviewing the family about the donor's medical history and suitability for transplant and obtaining consent, said Parker, who added that he had never been involved in tissue procurement before but became convinced "there's a terrific need out there."
Guyett tried to drum up business at a seminar sponsored by the Funeral Consumers Alliance of the Triangle and the American Association of Retired Persons; this was the gathering captured on video. Guyett played a funeral director in a skit involving a family arguing over whether to donate a dead father's organs and tissues. Parker narrated the skit.
Guyett also pursued a related business — recycling titanium screws, implants and pins left over after cremation. Randy Bright, owner of Covenant Cremation Service in Wake Forest, N.C., was among those who let Guyett take these materials.
"There's no money exchanged at all," Bright said. "What are we going to do with them? We had no idea. It didn't cost the family or anything for that. And we didn't really have a way to dispose of them. ... It sounded like a good situation."
When Guyett proposed expanding the recyling business through the Cremation Association of North America, he made business claims that have come into question. He gave Jack Springer, the group's executive director, a list of 10 mortuaries that he said he dealt with regularly. Reached by AP, at least two — Miller-Jones of Hemet, Calif., and Serenity Mortuary Service of Phoenix — said they didn't know Guyett or his company.
"He had never done anything with us," said Timothy Hassett, owner of Serenity.
Likewise, Mike McGhee, general manager of Forbis & Dick Funeral Service in Greensboro, N.C., said he had no idea why Guyett listed his company as one of his business affiliates.
"I have been here for 27 years, and I can assure you that our firm has never had any dealings with this gentleman," he said. "This is abhorrent and repugnant to me," McGhee said of the concerns about Guyett. "I intend to find out why he used our name."
Guyett even claimed a relationship with the federal government, telling the seminar crowd: "Over the last six months, we've recovered over 1,000 tissue specimens that were sent to the National Cancer Institute for research. Eighty percent of those donors were also accepted for transplant allografts."
A cancer institute spokeswoman said neither Guyett nor his firm has been a supplier.
The FDA closed Guyett's Raleigh operations down on Aug. 18.
According to the FDA's order, Guyett altered paperwork on the health history and age of at least five dead donors, eliminating mention of factors like cancer and drug use that might make them ineligible.
In a brief interview last week at his two-story brick home in Wakefield Plantation, a new and upscale subdivision in north Raleigh, the goateed, slightly balding Guyett said the FDA did not force him out, and that he had done nothing wrong.
"I closed on my own free will to pursue other ventures. I'm out of the tissue recovery business as of December," Guyett said.
Yet as recently as three months ago, Guyett repeated requests to David Campbell, owner of Cape Fear Crematory in Stedman, N.C., to use his facility on the outskirts of the Fort Bragg Army base to harvest tissues and medical implants. As he had in the past, Campbell declined, and said, "I'm kind of glad from what I'm seeing in the press these days."
The Guyett case follows that of Biomedical Tissue Services, a now-defunct New Jersey company accused of plundering corpses for tissue without families' permission, including the body of "Masterpiece Theatre" host Alistair Cooke. A former dentist, Michael Mastromarino, and three others face charges in that scandal.
That company, like Guyett's, was not accredited by the tissue bank association. There are more under-the-radar tissue brokers out there than the FDA would like to think, said Areta Kupchyk, a former FDA attorney who helped write tissue regulations and consults with tissue companies.
"He's probably an example of many small-timers around the country," Kupchyk said of Guyett. "They're the ones that are the most dangerous. They get a small niche and they can cause a lot of trouble."
___
Contributing to this story were science writer Seth Borenstein in Washington, national writer Allen G. Breed in Raleigh, N.C., AP writer Adam Goldman in New York, Western regional writer Angie Wagner in Las Vegas, and researcher Judy Ausuebel in New York.
___
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August 28th, 2006
ViroPharma Announces Positive Data from Phase 1b Combination Study of HCV-796 and Pegylated Interferon in Hepatitis C Patients
http://www.finanznachrichten.de/
EXTON, Pa., Aug. 28 /PRNewswire-FirstCall/ -- ViroPharma (Nachrichten) Incorporated today announced preliminary data from a Phase 1b study of HCV-796, a unique, orally dosed hepatitis C virus (HCV) polymerase inhibitor being co-developed with Wyeth Pharmaceuticals, a division of Wyeth . Preliminary antiviral data are available in the dose range of 100 mg BID to 1,000 mg BID of HCV-796 dosed over a 14-day period in combination with pegylated interferon alfa-2b.
These combination data demonstrate antiviral effects of HCV-796 across multiple genotypes of hepatitis C virus, in treatment-naive adult subjects with chronic hepatitis C infection. Across all dose groups, the combination of HCV-796 and pegylated interferon produced a mean viral reduction of between 3.3 and 3.5 log10 (99.95 percent to 99.97 percent) after 14 days of treatment compared to 1.7 log10 with pegylated interferon alone. During the treatment period, there was no evidence of viral rebound with the combination therapy relative to pegylated interferon alone. No dose-limiting toxicities were seen and although safety data remain blinded, tolerability was consistent with that expected from pegylated interferon.
"These data are clearly very promising as HCV-796 in combination with pegylated interferon appears highly potent with substantial antiviral activity across all doses tested," commented Colin Broom, ViroPharma's chief scientific officer. "To date we have not identified any dose-limiting toxicities with HCV-796 and plan to initiate Phase 2 with the 500 mg BID dose, to be followed by further evaluation of the dose response."
Phase 1b Clinical Trial Description
This 14-day randomized, double-blind, placebo-controlled, sequential-group study of ascending multiple doses enrolled subjects with chronic HCV infection who were naive to treatment. Subjects were enrolled in sequential, ascending dose cohorts with a target of 16 subjects (12 subjects receiving HCV-796 and 4 receiving placebo in each cohort). The first cohorts assessed the effect of HCV-796 as monotherapy compared to placebo (data from which were released on November 10, 2005). Subsequent cohorts were comprised of subjects who received pegylated interferon alfa-2b (PEG-Intron; 1.5 ug/kg/dose) on days -1 and 7 in combination with either placebo or HCV-796 (100 mg, 250 mg, 500 mg or 1000 mg) every 12 hours, from days 1 to 14. Sixty-four percent of patients in the combination therapy cohorts were infected with HCV genotype 1. The mean viral load for each treatment group at study entry was >6.0 log10 IU/ml HCV RNA.
Phase 1b Preliminary Antiviral Data
Preliminary data are available through treatment day 14 from subjects in four combination treatment groups (n= 9-11 subjects per group) and on 15 subjects who received pegylated interferon alone.
* Across all combination groups, the mean reduction from baseline in plasma HCV RNA ranged from 2.1 to 2.7 log10 on day 7 and 3.3 to 3.5 log10 on day 14. This compared to a reduction of 1.1 log10 on day 7 and 1.7 log10 on day 14 with pegylated interferon alone. Consistent with known effects of pegylated interferon, response varied by HCV genotype: - For genotype 1, mean reduction from baseline ranged from 1.5 to 2.3 log10 on day 7 and from 2.6 to 3.2 log10 on day 14 in the combination therapy groups compared to 0.9 log10 on day 7 and 1.3 log10 on day 14 for pegylated interferon alone. * Viral reduction greater or equal to 2 log10 at day 14 was achieved in 70 to 90 percent of subjects in all combination groups compared to 43 percent on pegylated interferon alone. * At day 14, 30 to 33 percent of patients in the combination groups receiving greater than or equal to 250 mg BID of HCV-796 achieved viral levels below the quantification limit of 50 IU/mL HCV RNA. Conference Call and Webcast
ViroPharma is hosting a live teleconference and webcast with senior management to discuss the clinical results on August 29, 2006 at 9:00 A.M. Eastern Time. To participate in the conference call, please dial (800) 391-2548 (domestic) and (302) 709-8328 (international). After placing the call, please tell the operator you wish to join the ViroPharma investor conference call.
Alternatively, the live webcast of the conference call can be accessed via ViroPharma's website at http://www.viropharma.com/. Windows Media or RealPlayer will be needed to access the webcast. An audio archive will be available at the same address until September 15, 2006.
About Hepatitis C
Hepatitis C is a blood-borne virus recognized as a major cause of chronic hepatitis worldwide. The World Health Organization estimates that 170 million persons worldwide are chronically infected with HCV, and three to four million persons are newly infected globally each year. According to the U.S. Centers for Disease Control and Prevention (CDC), about four million people in the U.S., or 1.8 percent of the population, are infected with HCV.
Currently, there is no specific antiviral agent directed against HCV that is commercially available, and no vaccine for prevention of HCV infection. Several interferon (IFN) products are available worldwide, but there are substantial limitations to the use of these products when given as monotherapy or in conjunction with ribavirin in the treatment of chronic HCV infection. In addition to the relatively poor treatment response in patients infected with genotype 1 HCV, the most common strain in the U.S., Western Europe and Japan, the considerable side effects frequently associated with the use of IFN can lead to discontinuation of therapy in approximately 20 percent of patients.
About ViroPharma Incorporated
ViroPharma Incorporated is committed to the development and commercialization of products that address serious diseases treated by physician specialists and in hospital settings. ViroPharma commercializes Vancocin(R), approved for oral administration for treatment of antibiotic-associated pseudomembranous colitis caused by Clostridium difficile and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains (for prescribing information, please download the package insert at http://www.viropharma.com/docs/
pulvules_pi.pdf). ViroPharma currently focuses its drug development activities in viral diseases including cytomegalovirus (CMV) and hepatitis C (HCV). For more information on ViroPharma, visit the company's website at http://www.viropharma.com/.
Certain statements in this press release contain forward-looking statements that involve a number of risks and uncertainties, including those relating to the company's anticipated schedule relating to its HCV clinical development program as well as its ability to find an effective small molecule antiviral treatment for HCV disease. Our actual results could differ materially from those results expressed in, or implied by, these forward-looking statements. Conducting clinical trials for investigational pharmaceutical products is subject to risks and uncertainties. The data that is described in this press release is preliminary and full analysis of the data, or further testing such as the planned Phase 2 clinical studies of HCV-796 with pegylated interferon, may not support any or all of the statements in this press release. There can be no assurance that ViroPharma's additional HCV studies will yield positive results, or that ViroPharma will be successful in gaining regulatory approval of any of its HCV product candidates. These factors, and other factors, including, but not limited to those described in ViroPharma's quarterly report on Form 10-Q for the quarters ended March 31, 2006 and June 30, 2006 filed with the Securities and Exchange Commission, could cause future results to differ materially from the expectations expressed in this press release. The forward-looking statements contained in this press release may become outdated over time. ViroPharma does not assume any responsibility for updating any forward-looking statements.
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Tripep Produces Additional Positive Data for Its Hepatitis C DNA Vaccine Using Inovio's DNA Delivery System
http://www.finanznachrichten.de/
Inovio Biomedical Corporation (AMEX:INO) announced today that its partner, Tripep AB of Sweden, has achieved additional positive pre-clinical results showing that its ChronVac-C DNA vaccine combined with Inovio's MedPulser(R) DNA delivery system produced a strong immune response against hepatitis C virus (HCV) in a large animal model. Ongoing toxicity studies of ChronVac-C(R) delivered using Inovio's electroporation-based system revealed that the combination induces a humoral response in rabbits that is comparable to results previously observed in mice.
"These results provide encouragement that the combination of ChronVac-C with the MedPulser DNA delivery system may work well in humans and indicate that our collaboration with Inovio is progressing very well," said Tripep's CEO, Jan Nilsson.
"We are pleased to see continuing positive data from this program and Tripep's ongoing commitment to the development of this DNA vaccine with the goal of initiating a clinical study using Inovio's MedPulser(R) DNA delivery system," stated Avtar Dhillon, MD, Inovio's president and CEO.
About Hepatitis C and ChronVac-C
Hepatitis is a disease characterized by inflammation of the liver. Hepatitis C virus (HCV) is a major cause of acute hepatitis. HCV is spread primarily by direct contact with human blood, the major causes worldwide being the use of unscreened blood transfusions, and re-use of needles and syringes that have not been adequately sterilized. As many as 70% - 90% of newly infected patients may progress to develop chronic infection (WHO: 2002). Of those with chronic liver disease, 5% - 20% may develop cirrhosis. About 5% of infected persons may die from the consequences of long term infection (due to liver cancer or cirrhosis). Globally, an estimated 170 million people are chronically infected with HCV, which represents a reservoir sufficiently large for HCV to persist, and 3 to 4 million persons are newly infected each year. In the US, while new incidences of HCV have dropped dramatically, an estimated 4.1 million (1.6%) Americans have been infected with HCV, of whom 3.2 million are chronically infected (Centers for Disease Control and Prevention: 2006).
HCV infections in the liver do not trigger an immune response very effectively. Certain antiviral therapies, while expensive, are somewhat effective in treating hepatitis C, but there is no vaccine currently available to prevent hepatitis C. ChronVac-C(R) is designed to be a therapeutic DNA vaccine that can stimulate the body's immune system. Animal experiments have demonstrated that ChronVac-C vaccination activates B cells and T-cells (the latter being regarded as the most significant to clearing the chronic infection relating to hepatitis C) that killed cells producing HCV protein. In humans, the ChronVac-C DNA plasmid would be injected into muscle tissue, where vaccinations are usually given, and taken up by muscle cells with the assistance of Inovio's electroporation-based DNA delivery system. These muscle cells would be expected to then produce predetermined proteins that may activate the body's immune system to attack all cells producing HCV proteins.
About Tripep AB
Tripep AB is a Swedish biotechnology research company that develops and commercialises candidate drugs based on patented and proprietary technologies. Its main focuses are research and clinical development of ChronVac-C(R), a therapeutic vaccine against hepatitis C; preclinical research focusing on the development of the therapeutic and prophylactic vaccines against influenza A and HIV; the RAS(R) technology platform. More information is available at www.tripep.se or contact Jan Nilsson, CEO at +46 8 449 8480 or jan.nilsson@tripep.se.
About Inovio Biomedical (Nachrichten) Corporation
Inovio Biomedical Corporation is a late stage biomedical company focused on commercializing its proprietary Selective Electrochemical Tumor Ablation (SECTA) therapy. SECTA is designed to target a significant unmet clinical need: a local treatment for solid tumors, with selective killing of cancer cells while preserving surrounding healthy tissue. Inovio is moving its lead product, the MedPulser(R), through pre-marketing studies for head and neck cancer and skin cancers in Europe, where it has CE Mark accreditation, a U.S. Phase III pivotal study for head and neck cancer, and Phase I trials for pancreatic and breast cancer. Merck, Vical, University of Southampton, and H. Lee Moffitt Cancer Center are using Inovio's gene delivery technology in clinical studies of novel DNA therapeutics delivered using electroporation. Inovio is a leader in developing human therapeutic applications of electroporation, with the industry's most extensive patent portfolio covering in vivo electroporation. More information is available at www.inovio.com.
This press release contains certain forward-looking statements relating to our plans to develop our electroporation drug and gene delivery technology. Actual events or results may differ from our expectations as a result of a number of factors, including the uncertainties inherent in clinical trials and product development programs (including, but not limited to, the fact that pre-clinical results referenced in this release may not be indicative of results achievable from testing in humans), the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of Inovio's technology as a delivery mechanism, the availability or potential availability of alternative therapies or treatments for the conditions targeted by Inovio or its collaborators, including alternatives that may be more efficacious or cost-effective than any therapy or treatment that Inovio and its collaborators hope to develop, evaluation of potential opportunities, issues involving patents and whether they or licenses to them will provide Inovio with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether Inovio can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of our technology by potential corporate or other partners or collaborators, capital market conditions, and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2005, our Form 10-Q for the six months ended June 30, 2006, and other regulatory filings. There can be no assurance that any product in our product pipeline will be successfully developed or manufactured, or that final results of clinical studies will be supportive of regulatory approvals required to market licensed products.
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August 29th, 2006
Blacks Less Apt to Respond to Hepatitis C Therapy
http://www.reutershealth.com
NEW YORK (Reuters Health) - African American adults with chronic hepatitis C virus (HCV) infection are less likely to respond to standard combination therapy with peginterferon and ribavirin, a study confirms.
In a statement, study author Dr. Charles D. Howell of the University of Maryland in Baltimore said the reduced response rate among African American patients is not caused by "the usual predictors," such as patient age, gender, HCV levels prior to treatment, amount of fibrosis in the liver biopsy nor amount of medication taken.
In a multicenter treatment trial, 196 African American and 205 Caucasian American patients with HCV infection and similar baseline characteristics received standard treatment consisting of peginterferon alfa-2a (180 micrograms/week) and ribavirin (1000 to1200 mg/day) for up to 48 weeks.
The response rate was 28 percent in African Americans compared with 52 percent in Caucasian Americans, a significant difference.
Racial differences in viral responses were evident as early as 4 weeks after the start of treatment, the team notes. "Breakthrough viremia" occurred more frequently in African Americans than Caucasian Americans (13 percent vs. 6 percent), but relapse rates were comparable (32 percent vs. 25 percent).
The proportion of the total maximum dose of peginterferon and ribavirin taken was lower among African Americans than Caucasian Americans. However, in multivariate analysis, this did not account for the racial difference in response rates.
The basis for the racial difference in response rates is being addressed by ongoing supplementary studies.
It's estimated that 1.3 percent of the US population, approximately 3.2 million Americans, have chronic HCV infection. HCV is now the leading cause of chronic liver disease and the most common indication for liver transplantation in the US.
SOURCE: Gastroenterology August 2006.
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Nabi Biopharmaceuticals Acquires Exclusive Rights to Novel Plasma Fractionation Technology from ProMetic Life Sciences
http://biz.yahoo.com
-- Technology Expected to Give Company's Hyperimmune Product Candidates Key Competitive Advantages: Increased Yield and Better Product Margins --
BOCA RATON, Fla., Aug. 29 /PRNewswire-FirstCall/ -- Nabi Biopharmaceuticals (Nasdaq: NABI - News) today announced that it has obtained the exclusive rights to use a novel hyperimmune immunoglobulin extraction technology from ProMetic Life Sciences Inc., a global biopharmaceutical company based in Montreal, Canada, in the manufacture of certain of Nabi Biopharmaceuticals' pipeline hyperimmune products. Access to this technology is expected to provide higher yields of Nabi Biopharmaceuticals' Civacir® [Hepatitis C Immune Globulin (Human)] and Altastaph® [Staphylococcus aureus Immune Globulin Intravenous (Human)]. Nabi Biopharmaceuticals also has an option to use the technology with its marketed product, Nabi-HB® [Hepatitis B Immune Globulin (Human)] and Nabi-HB(TM) Intravenous [Hepatitis B Immune Globulin (Human) Intravenous], as well as additional product candidates.
The agreement combines ProMetic's patented plasma proteins purification technology with Nabi Biopharmaceuticals' expertise in the large-scale development and manufacture of hyperimmune products. Nabi Biopharmaceuticals expects to achieve a number of benefits through the utilization of ProMetic's technology, including a more efficient manufacturing process and higher product margins.
"The advantage of the ProMetic technology is that it affords Nabi Biopharmaceuticals the ability to maximize the yield of specific immunoglobulins from a liter of hyperimmune plasma, and, as a result, reduces the cost of manufacturing and increases the capacity for production of some its most promising product candidates," stated Raafat Fahim, Ph.D., senior vice president research, technical and production operations, Nabi Biopharmaceuticals.
Thomas H. McLain, chairman, chief executive officer and president, Nabi Biopharmaceuticals, stated, "This agreement exemplifies our commitment to maximizing Nabi Biopharmaceuticals' core competencies and assets, including our plasma collection centers and manufacturing facility. We look forward to continuing to advance our hyperimmune product candidates, which we believe hold strong commercial promise and for which there is a clear clinical need."
About the Agreement
Under the terms of the agreement, Nabi Biopharmaceuticals obtains the exclusive worldwide rights to use ProMetic's plasma fractionation technology in the development of several of Nabi Biopharmaceuticals' hyperimmune product candidates, including Civacir and Altastaph. In addition, Nabi Biopharmaceuticals obtains an option for the exclusive North American rights to this technology for use with Nabi-HB and in the development of Nabi-HB Intravenous and certain possible product candidates.
Pierre Laurin, ProMetic's chief executive officer and president, stated, "We are pleased to partner with one of the world's leaders in the field of blood-derived products. Nabi HB has over 85 percent of the anti-hepatitis B immunoglobulin U.S. market for the prevention of hepatitis B re-infection in hepatitis B-positive liver transplant patients. We are looking forward to helping, through our technology, in the treatment of diseases for which there are few options available. We expect our Mimetic Ligand(TM) technology will allow Nabi Biopharmaceuticals to obtain higher recovery yields of specific hyperimmunes from plasma."
Nabi Biopharmaceuticals has previously assessed ProMetic's fractionation technology on a pilot scale, which supports its belief that the licensed technology can be used with larger-scale manufacturing operations. These activities are aligned with the company's clinical development strategy, which includes conducting "proof-of-concept" studies to best inform and establish optimal Phase III programs.
About Civacir
Civacir is an investigational human polyclonal antibody product that contains antibodies to the hepatitis C virus (HCV). In February 2006, Nabi Biopharmaceuticals announced that Civacir had been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA). This designation facilitates the development of products that treat serious diseases where an unmet medical need exists. Civacir has also gained Orphan Medicinal Product (OMP) designation in Europe. If a product with OMP designation is the first to receive marketing authorization in Europe for its designated indication, the product will be entitled to 10-year market exclusivity, thereby preventing a similar drug from receiving authorization for the same indication during this period. Civacir also has Orphan Drug Status in the United States. This provides a seven-year period of market exclusivity in the United States when the product is approved.
About Altastaph
Altastaph is an investigational human antibody-based product containing antigens to S. aureus types 5, 8 and 336 and may provide protection against S. epidermidis. Altastaph is being developed as a treatment for patients with persistent S. aureus and S. epidermidis infections and those who do not optimally respond to an antibiotic; a prophylaxis for patients (e.g. ICU patients; emergency surgery patients; and neonates) who are at risk for S. epidermidis and S. aureus infections; and a combination antibody and vaccine regimen designed to prevent recurrence of these infections in hospital patients.
About Nabi-HB Intravenous
Nabi-HB Intravenous is designed to prevent the re-infection of hepatitis B disease in HBV-positive liver transplant patients. Nabi Biopharmaceuticals filed a BLA with the U.S. Food and Drug Administration (FDA) for this intravenous formulation of their marketed product, Nabi-HB. If approved, this formulation would be the only product available in the U.S. indicated for the protection of the transplanted liver from HBV infection in HBV-positive liver transplant patients. The drug has received Orphan Drug Status in the United States and the BLA has been granted expedited review by the FDA.
About Nabi Biopharmaceuticals
Nabi Biopharmaceuticals leverages its experience and knowledge in powering the immune system to develop and market products that fight serious medical conditions. The company has three products on the market today: PhosLo® (calcium acetate), Nabi-HB® [Hepatitis B Immune Globulin (Human)], and Aloprim(TM) (allopurinol sodium) for Injection. Nabi Biopharmaceuticals is focused on developing products that address unmet medical needs and offer commercial opportunities in its core business areas: hepatitis and transplant, kidney disease (nephrology), Gram-positive bacterial infections and nicotine addiction. For a complete list of pipeline products, please go to: http://www.nabi.com/pipeline/index.php. The company is headquartered in Boca Raton, Florida. For additional information about Nabi Biopharmaceuticals, please visit Nabi's website: http://www.nabi.com.
About ProMetic Life Sciences
ProMetic Life Sciences Inc. is a biopharmaceutical company specialized in the research, development, manufacture and marketing of a variety of commercial applications derived from its proprietary Mimetic Ligand(TM) enabling technology. This technology is used in large-scale purification of biologics and the elimination of pathogens. ProMetic is also active in therapeutic drug development with the mission to bring to market effective, innovative, lower cost, less toxic products for the treatment of inflammation and cancer. Its drug discovery platform is focused on replacing complex, expensive proteins with synthetic "drug-like" protein mimetics. Headquartered in Montreal (Canada), ProMetic has R&D and manufacturing facilities in the UK and business development activities in the U.S., Europe, Asia and MENA countries (Middle East and North Africa).
Forward-Looking Statement
Statements in this press release about the company that are not strictly historical are forward-looking statements and include statements about our products in development, the market for such products, and regulatory approval of our product candidates. You can identify these forward-looking statements because they involve our expectations, beliefs, intentions, plans, projections, or other characterizations of future events or circumstances. These forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those in the forward-looking statements as a result of any number of factors. These factors include, but are not limited to, risks relating to the company's ability to advance the development of products currently in the pipeline or in clinical trials; maintain the human and financial resources to commercialize current products and bring to market products in development; obtain regulatory approval for its products in the U.S., Europe or other markets; successfully develop, manufacture and market its products; successfully partner with other companies; realize future sales growth for its biopharmaceutical products; maintain sufficient intellectual property protection or positions; raise additional capital on acceptable terms; re-pay its outstanding convertible senior notes when due. Many of these factors are more fully discussed, as are other factors, in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2005 and Quarterly Report on Form 10-Q for the Quarter ended July 1, 2006 filed with the Securities and Exchange Commission.
Source: Nabi Biopharmaceuticals
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August 30th, 2006
New Perspectives for T Cell-Based Hepatitis C Vaccines Are the Focus of Review
http:// www.therapeuticsdaily.com
Vaccine Weekly - Aug. 30, 2006
2006 AUG 30 - (NewsRx.com) -- A researcher reviews new perspectives for T-cell-based hepatitis C vaccines in a recent issue of the Journal of Hepatology.
According to the review, "Three percent of the world's population is chronically infected with the hepatitis C virus (HCV) and at risk of developing liver cancer. Effective cellular immune responses are deemed essential for spontaneous resolution of acute hepatitis C and long-term protection. Here, we describe a new T-cell HCV genetic vaccine capable of protecting chimpanzees from acute hepatitis induced by challenge with heterologous virus."
"Suppression of acute viremia in vaccinated chimpanzees occurred as a result of massive expansion of peripheral and intrahepatic HCV-specific CD8+ T lymphocytes that cross-reacted with vaccine and virus epitopes," said Carlo Ferrari at the University of Parma.
"These findings show that it is possible to elicit effective immunity against heterologous HCV strains by stimulating only the cellular arm of the immune system, and suggest a path for new immunotherapy against highly variable human pathogens like HCV, HIV, or malaria, which can evade humoral responses," stated the author.
Ferrari published the review in the Journal of Hepatology (New perspectives for T-cell-based HCV vaccines. J Hepatol, 2006;45(1):163-165).
For more information, contact Carlo Ferrari, Division of Infectious Diseases and Hepatology, Azienda Ospedaliero-Universitaria di Parma, I-43100 Parma, Italy. E-mail: cafer@tin.it.
Publisher contact information for the Journal of Hepatology is: Elsevier Science BV, PO Box 211, 1000 AE Amsterdam, The Netherlands.
This article was prepared by Vaccine Weekly editors from staff and other reports.
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Workshop Focuses to Open Hepatitis C Clinic
http://www.sun-herald.com
By DAWN KREBS
Feeling Fit Editor
PUNTA GORDA -- Dr. Mark Asperilla's vision of bringing assistance to those affected by the hepatitis C virus is almost a reality.
According to the Department of Health, in 2005 there were only 218 reported cases in Charlotte County. It is estimated that 1.8 percent of the local population are infected with -- but may not know they have -- the potentially fatal virus.
Representatives of agencies from throughout Southwest Florida met at the Charlotte County Health Department Wednesday morning to discuss the strategic plan for the opening of a hepatitis C clinic, tentatively named the Hope Clinic of Charlotte County. The sobering statistics were included in the strategic plan of the clinic to help illustrate the need for hepatitis C services in the county.
Representatives from the health department, Charlotte County government, pharmaceutical companies, the Charlotte County Medical Society and St. Vincent de Paul Pharmacy gathered to offer their input and ideas.
”Before, it (the planning for a clinic) was scattered and now it's tighter,” Asperilla said. “Strategic planning today is important so we can move forward. The ball is rolling.”
According to the Florida Department of Health, chronic hepatitis C infection is the most common blood-borne infection in the United States. An estimated 4 to 5 million Americans, including approximately 300,000 Floridians, are infected with hepatitis C. The exact numbers of individuals with hepatitis C are unknown, because the disease's symptoms can go unrecognized for a number of years.
”There are many things on the horizon,” said Garry Allshouse, the epidemiology supervisor for the Charlotte County Health Department. “The sooner we get our act together, the better.”
One of the discussion topics focused on the facility's purpose.
”We need to redefine the word 'clinic,'” said Charlotte County Health Department Administrator Steve Mitnick. “We need to be looking at a much bigger goal, one that includes prevention.”
Nonprofit organizations in the community also stand behind the formation of a hepatitis C clinic in the area, including local Knights of Columbus, Rotary clubs and the hepatitis C support group.
Asperilla is scheduled to speak about the clinic at the county's budget hearings, with the earliest one scheduled for Sept. 14.
”I think this is wonderful,” said Debbie Barnes, president of the Tamps Bay Hepatitis and Live Disease Support Group in Gulfport, Fla. “It is exciting to see all of these resources in Charlotte County coming together to make this clinic the best it can be.”
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Japan Court Awards Damages over Hepatitis C Infections
http://www.todayonline.com/
A court has ordered the Japanese government and drugmakers to pay 168 million yen (1.4 million dollars) to 11 people who contracted hepatitis C from tainted blood products.
Wednesday's ruling was the second issued by Japanese courts over the scandal, in which thousands of people allegedly contracted the virus through products meant to stop bleeding during surgeries and childbirth.
The Fukuoka District Court said the government and two drugmakers -- Mitsubishi Pharma Corp. and a subsidiary -- were responsible for the infections through the product fibrinogen.
Presiding judge Keiji Suda said the firms must pay damages for infections after 1985, when they allegedly knew about the risks, and that the government was responsible for infections since 1987.
The latest verdict followed a similar decision in June, when the Osaka District Court ordered the government and Mitsubishi Pharma to pay a total of 2.24 million dollars to nine plaintiffs.
More than 280,000 people are estimated to have been administered with fibrinogen -- produced and sold by Mitsubishi, which was known then as Green Cross Corp., with the state's certificate -- after 1980.
At least 10,000 of those are said to have contracted the disease.
The tainted blood product was widely used at Japanese hospitals until 1988 even though the US government had informed the public of the danger and retracted its certificate in 1977.
Mitsubishi Pharma has been hit by a series of scandals due to its HIV- and hepatitis C-tainted products and was rescued through a merger.
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Pharmexa Receives Approval of Phase II Application with GV1001 in Liver Cancer
http://www.pharmalive.com
Summary: Pharmexa has received the necessary approvals in France to start the Heptovax Phase II trial with GV1001 in liver cancer.
Hørsholm, Denmark, Aug. 30, 2006--Pharmexa has received the necessary approvals in France regarding the Heptovax Phase II trial with GV1001 in liver cancer and will now initiate recruitment of patients. Approvals in Spain and Germany are expected within the next few weeks.
The Heptovax trial is a Pase II trial evaluating the safety and efficacy of GV1001 in advanced hepatocellular carcinoma ("HCC" or "liver cancer"). The trial will enrol patients from 3 centres in Spain, France and Germany.
Trial design
Up to 41 patients with advanced stage liver cancer will receive a single pre-treatment dose of the chemotherapeutic drug cyclophosphamide three days prior to the start of immunotherapy, followed by doses of GV1001 plus GM-CSF three times in the first week, and once weekly in week 2,3,4 and 6. Thereafter, GV1001 plus GM-CSF will be given once a month. All patients will be treated for a minimum of 6 months unless they show symptomatic progression, in which case patients will be discontinued from the trial.
The primary endpoint of the trial is efficacy, measured by objective tumor response (modified RECIST). Secondary endpoints include the safety and immunogenecity of the vaccine. Approximately half of the patients with advance stage liver cancer die within a year and survival benefits in the trial will also be measured.
Depending on the speed at which patients can be recruited, results from the trial will therefore be available early 2008. If the results are positive, Pharmexa plan to initiate a pivotal Phase III trial of GV1001 in liver cancer.
Liver cancer represents a large unmet need
HCC is the fifth most common cancer in the world. More than 600,000 new cases of hepatocellular carcinoma occur worldwide each year with almost as many deaths. In Europe alone, more than 50,000 new cases occur each year. The incidence of HCC, however,
varies a great deal between different countries and regions, occurring significantly more often in Japan than in Europe. Moreover, accumulating evidence indicates that the incidence of liver cancer is rising. HCC is twice as common in men as in women and has a strong association with hepatitis B and hepatitis C infection as well as with cirrhosis. Early and medium stage liver cancers are sub-optimally treated with surgery, radiofrequency ablation and chemoembolization while no treatment options really exist for the disease in its advanced stage. Current chemotherapy treatments are limited by the site of the cancer - the cirrhotic liver - because of dose limiting liver toxicity concerns with these agents.
GV1001: A cancer vaccine targeting telomerase
GV1001 is a peptide vaccine that activates the immune system - primarily the immune system's T-cells - to recognize and kill cancer cells. GV1001 targets an enzyme called telomerase. Telomerase is seldom found in normal cell types but is over expressed in most cancer cells. In scientific circles, telomerase activity is considered a key factor in the process whereby cancer cells lose their normal mortality, which is a common feature for all cancers. In theory, GV1001 could therefore turn out to be a universal cancer vaccine and Pharmexa's development strategy for GV1001 reflects this.
Additional information:
Jakob Schmidt, Chief Executive Officer, telephone +45 4516 2525
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August 31st, 2006
Liver Biopsy Informative in HIV and HCV Coinfection
http://www.medscape.com/
NEW YORK (Reuters Health) Aug 31 - Patients with HIV and chronic hepatitis C virus (HCV) infection may have normal alanine aminotransferase (ALT) levels, but nonetheless they should probably have a liver biopsy, Spanish researchers report in the September 1st issue of Clinical Infectious Diseases.
Dr. Juan Berenguer of Hospital General Gregorio Maranon, Madrid and colleagues found that there may be significant fibrosis in such cases.
The researchers studied 256 patients with HIV and HCV coinfection. Of this group, 24 (9.4%) had an ALT level within the normal range on at least two occasions within a 6-month period.
Clinical data and histological findings showed advanced fibrosis (stage F3 and F4) in 78 (33.7%) of the patients with elevated ALT levels.
This was not true of any of the patients with normal ALT. However, 23 of the 24 in this group (96%) had some degree of fibrosis, and 7 (29%) had F2 stage fibrosis.
There were no differences in a variety of factors including, age, CD4+ cell count and duration of HCV infection among subjects with and without normal ALT levels. On the other hand, a significantly higher proportion of patients with high ALT levels had the HCV 3 genotype than was the case in those with normal ALT levels (26.9% versus 4.2%).
In light of these findings, the researchers suggest liver biopsy in patients with HIV and HCV coinfection who have normal ALT levels, "to determine the extent of liver fibrosis and, consequently, to assess suitability of treatment."
Clin Infect Dis 2006;43:640-644.
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Safe-Injection-Site Supporters Demand Answers from Ottawa
http://www.theglobeandmail.com
SHANNON KARI
With deadline looming, Ottawa says fate of Insite facility to be announced 'shortly'
VANCOUVER -- The federal government was urged yesterday to stop delaying its decision about whether to permit a safe-injection facility in Vancouver to continue operating after Sept. 12.
"It is getting kind of late in the game," said Thomas Kerr, a scientist at the B.C. Centre of Excellence in HIV/AIDS, who has conducted a number of scientific studies about the impact and effectiveness of the Insite facility.
"We have a community that is waiting to find out what is going to happen. We have a large research staff that is wondering whether they are going to continue gathering data in two weeks," Dr. Kerr said. "What we need is an answer."
Prime Minister Stephen Harper was a few blocks from the news conference held by supporters of Insite and declined to provide that answer, even though the facility's exemption from the country's drug laws expires in less than two weeks.
"The safe-injection site decision is the Health Minister's decision," Mr. Harper said after announcing a federal funding commitment for the 2010 Winter Olympics.
"I won't be announcing anything myself on that, on this trip. I anticipate he [Health Minister Tony Clement] will be making an announcement on that very shortly."
The Health Minister travelled to Sweden last week and is believed to have spoken to drug policy officials in that country about the merits of safe-injection sites.
"It is kind of a curious choice because Sweden has no experience with these facilities," Dr. Kerr said. "We don't need to go to Sweden to look for these answers. We have the Vancouver Police Department, Vancouver Coastal Health and many community organizations doing some of the most innovative work in the world."
The pilot project, which has operated for the past three years, permits addicts to inject their drugs in clean surroundings, supervised by trained staff.
The continued operation of the Insite facility has been endorsed by the chief of police in Vancouver, Mayor Sam Sullivan, community leaders and four former mayors.
With the deadline looming for the federal government to make a decision about the site, the RCMP issued a news release this week that said it had concerns and called for more scientific research.
Dr. Kerr explained that there have been 15 scientific studies about the impact of the site and many have been published in prestigious journals such as The Lancet and the New England Journal of Medicine.
"My great disappointment is that the RCMP has failed to acknowledge scientific evidence that the international scientific community has endorsed and accepted," he said.
He noted that the RCMP commissioned two reports from criminologists about the community impact of the safe-injection facility, which were favourable. "Yet we are not hearing about those reports," Dr. Kerr said. "I think it's time to acknowledge that this is a simple medical intervention. A sterile injection is better than an unsterile injection."
Susie Ruttan, a teacher whose son is recovering from drug addiction, also praised the Insite facility. "It just comes down to saving lives. What can possibly be argued against that?"
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Relatives Lose Right to Block Organ Donations in UK
http://www.reutershealth.com/
LONDON (Reuters) - Families will lose the right to block their relatives' wish to donate their organs under reforms, which come into force on Friday.
Currently families can stop doctors from taking their loved ones' organs even if they carried a donor card. About one in 10 planned donations is blocked at present.
"There is a critical shortage of donated organs," said Chris Rudge, Managing Director of UK Transplant, the NHS department that runs Britain's organ donation system. "The wishes of the deceased must be put first."
Doctors have been told to urge families to change their minds if they try to stop the planned organ donation. "We know that in most cases families will agree to donation if they know (that) was their loved one's wish," Rudge added.
The Human Tissue Act was drawn up after the organ scandal at Liverpool's Alder Hey Hospital. Hundreds of babies' organs were removed without their parents' consent between 1988 and 1996. A similar organ retention scandal at the Bristol Royal Infirmary sparked calls for action.
Under the new law, it will be an offence to remove and store human tissue without permission in England, Wales and Northern Ireland. Anyone found guilty could be fined or jailed for three years.
It will also be illegal to remove and test genetic material without consent.
A new body, the Human Tissue Authority, will regulate the removal, storage, use and disposal of organs. "People will be reassured that their wishes expressed while they were alive are now more likely to be followed," said HTA Chief Executive Adrian McNeil.
Health Minister Rosie Winterton said the reforms were a "huge milestone", while the Royal College of Pathologists said it hoped the changes would help restore public confidence in tissue research.
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September 1st, 2006
Gov't to Appeal Court Order to Pay Damages to Hepatitis C Victims
http://asia.news.yahoo.com
(Kyodo) _ The government plans to appeal a court ruling ordering it to pay damages to people infected with the hepatitis C virus after being treated with tainted blood products, Health, Labor and Welfare Minister Jiro Kawasaki said Friday.
The Fukuoka District Court ordered the state and drug companies on Wednesday to pay a combined 168 million yen in damages to 11 of 18 plaintiffs who contracted the virus.
Presiding Judge Keiji Suda said in the ruling that the state failed to implement necessary regulations against infections by November 1980 at the latest, when the risk of a blood product fibrinogen was confirmed, and that the two drugmakers -- Mitsubishi Pharma Corp. and its subsidiary Benesis Corp. -- are also responsible for the infections.
The 18 plaintiffs sought 1.17 billion yen in total, saying they were treated with fibrinogen manufactured by the now-defunct Green Cross Corp. and other blood-clotting drugs after giving birth or undergoing operations between 1977 and 1988, and developed hepatic cirrhosis or chronic hepatitis.
An estimated 2 million people have been infected with hepatitis C across Japan, mainly through tainted blood products, according to medical experts.
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NDRI Receives Josiah Macy, Jr. Foundation Grant
http://www.eurekalert.org
NDRI is pleased to announce the receipt of a starter grant from the Josiah Macy, Jr. Foundation to support the implementation and evaluation of a training program on the hepatitis C virus for clinical and non-clinical staff in 5 New York City outpatient drug treatment programs. NDRI investigators have been active in the development of evidence-based training programs intended to enhance the services delivered in drug treatment programs.
As hepatitis C has taken on greater importance as a public health challenge, it is essential that drug treatment service providers know how to institute effective public health responses. "We believe this grant will assure continued progress in developing a model training program that can be used throughout the Nation," said Dr. Shiela M. Strauss, Ph.D., NDRI principal investigator.
Hepatitis C is the most common blood-borne infectious disease in the United States, with high impact on the underserved population of drug users. Past work in this area by NDRI investigators indicated that an intervention that addresses the knowledge and enhances the communication skills of staff can influence the health-seeking and health-preserving behaviors of patients in the program.
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