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Week Ending: October 1st, 2005
Alan Franciscus
Editor-in-Chief
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This Issue:
• (UK): 50,000 Londoners Are Addicted to Crack, Says Study
• Prediction of Survival in Patients with Cirrhosis
• Unified System of Naming Hep C Virus Genotypes
• Pharmacists Able to Detect 'Hidden' Hepatitis C in Drug Users
• Living with the Sleeping Dragon
• Coley Up on Hepatitis C Trial Start
• Migenix Completes Hepatitis C Treatment Trial
• SciClone to Report Top-Line Data from First U.S. Hepatitis C Phase 3 Trial by Mid-December 2005
• Dynavax Introduces TOLAMBA(TM) and HEPLISAV(TM) Brand Names for Ragweed Allergy and Hepatitis B Vaccine Products
• Outcomes of Hep C in Latinos and Caucasians
• AVI BioPharma Initiates Hepatitis C Clinical Trial
• Bradenton Doctor Chips Away at Hepatitis C Virus
• Bioenvision's Phase II Trial of Virostat Very Active in Hepatitis C; Phase II Results to Be Presented at UBS Global Life Sciences Conference
• 1 Million Hep C Patients Could Respond to Therapy by 2014
• CALIFORNIA: "Officials Step Closer to Needle Exchange"
• Xtlbio Has Initiated the Phase 1a Clinical Trial of XTL-6865 for the Treatment Of Hepatitis C
• Hepatitis C Caring Ambassadors Program Hosts Pearl Health and Music Fair to Raise Hepatitis C Awareness
• Forest Laboratories, Inc. and Cypress Bioscience, Inc. Announce Results of Phase III Study for Milnacipran as a Treatment for Fibromyalgia
• Hepatitis Suit
• GREECE: Hepatitis C Is on the Rise
• China's Doctors Not up to Scratch on Hepatitis B
• RESOURCE's Recovery Resource Center Receives Federal Funding for a Ground- Breaking Substance-Abuse, HIV/AIDS, and Hepatitis Prevention Program
• World Hepatitis C Awareness Day to Be Observed on October 1
• Failure to Tackle Hepatitis C 'Will Cost UK £8bn'
• European Governments Warned: Take Action on Hepatitis C Now or Risk a Global Epidemic
• Doctors Warn of Hepatitis 'Timebomb'
• Hepatitis C Infection in Scotland Twice UK Average
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September 20th, 2005
UNITED KINGDOM: "50,000 Londoners Are Addicted to Crack, Says Study"
The Guardian (London)
James Meikle
Recently released figures suggest that 46,000 Londoners ages 15-44 - or about 1 percent of that age group - are injecting or smoking crack cocaine, creating serious implications for health and crime in the city. Previous estimates had placed the level of crack addiction at about a quarter of the new figure.
Users who inject crack are exposed to the threat of blood-borne infections such as HIV and hepatitis C. There are also increased risks among crack users of psychiatric problems, like paranoia and depression, and links to violent behavior. Around three in five users also take opiates such as heroin, according to researchers at Imperial College London and Bristol University.
The researchers compiled the figures using several sources for 12 London boroughs. They also sought to assess the scale of the problem among injection drug users. They multiplied the figures to cover the whole city, which suggested that 1.3 percent of the age group used crack.
"Although crack cocaine has been a cause of concern in many countries since the 1980s, there has not been the predicted epidemic across the UK until now," said Imperial College London's Matthew Hickman. "We must be cautious but the analysis suggests there is a substantial problem." Hickman warned against extrapolating the new findings to apply across Britain, noting that different cities have different profiles of drug taking.
Martin Barnes, head of the charity DrugScope, also advised that the latest figures should be interpreted with caution. He said the experience of some local communities and drug agencies supports evidence of a greater crack problem in London as compared with the national picture.
The study, "Capturing Crack Cocaine Use: Estimating the Prevalence of Crack Cocaine Use in London Using Capture-Recapture with Covariates", was published in the early online edition of Addiction, the journal of the Society for the Study of Addiction (doi:10.1111/j.1360-0443.2005.01244.x).
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September 24th, 2005
Prediction of Survival in Patients with Cirrhosis
SourceURL:http://www.gastrohep.com
Hepatic venous pressure gradient has an independent effect on survival in addition to the MELD score, and improves the calibrative ability of MELD, finds the latest issue of Hepatology.
Measurements of portal pressure, usually obtained via the hepatic venous pressure gradient may be a prognostic marker in cirrhosis.
Dr Rafael Bañares from Spain examined the inclusion of hepatic venous pressure gradient with Model for End-Stage Liver Disease (MELD) variables.
The researchers therefore evaluated whether this combination improves survival in patients with cirrhosis, as well as the models prognostic ability.
Retrospective analyses of all patients who had hepatic venous pressure gradient measurements between 1998 and 2002 were considered.
The research team developed proportional hazards Cox models, and evaluated prognostic calibrative and discriminative ability of the model.
1-mmHg increase in hepatic venous pressure gradient had a 3% increase in death risk – Hepatology
In this period, 693 patients had a hepatic hemodynamic study, and the team included 393 patients.
The researchers found that survival was significantly worse in those patients with greater hepatic venous pressure gradient value.
Hepatic venous pressure gradient remained as an independent variable in a model adjusted by MELD, ascites, encephalopathy, and age.
The research team observed that so that each 1-mmHg increase in hepatic venous pressure gradient had a 3% increase in death risk.
The team noted that hepatic venous pressure gradient significantly contributes to the calibrative predictive capacity of the prognostic model.
In addition, MELD score variables and age, were found to significantly contributes to the calibrative predictive capacity of the prognostic model.
However, discriminative ability improved only slightly.
Dr Bañares' team concluded, "Hepatic venous pressure gradient has an independent effect on survival in addition to the MELD score."
"Although inclusion of hepatic venous pressure gradient and age in a survival predicting model would improve the calibrative ability of MELD, its discriminative ability is not significantly improved."
Hepatol 2005: 42(4): 793-801
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September 26th, 2005
Unified System of Naming Hep C Virus Genotypes
SourceURL:http://www.gastrohep.com
The latest issue of Hepatology reports that a framework by which the Hepatitis C databases provides access to data on the virus, will internationally coordinate the assignment of new genotypes and subtypes in the future.
International standardization and coordination of the nomenclature of variants of Hepatitis C virus is increasingly needed.
More is discovered about the scale of Hepatitis C-related liver disease and important biological and antigenic differences that exist between variants.
Dr Peter Simmonds and a colleagues expert in the field of Hepatitis C genetic variability, met to re-examine the status of HCV genotype nomenclature.
The researchers aimed to resolve conflicting genotype or subtype names among described variants of Hepatitis C.
The team also planned to draw up revised criteria for the assignment of new genotypes as they are discovered in the future.
Hep C will be classified into 6 genotypes, representing the 6 genetic groups – Hepatology
The researchers examined the Hepatitis Virus Database from Japan, the Hepatitis C virus database from France, and Los Alamos in the USA.
A listing of all classified variants of Hepatitis C incorporates a number of agreed genotype and subtype name reassignments to create consistency in nomenclature.
The paper also contains consensus proposals for the classification of new variants into genotypes and subtypes.
The researchers working on the paper recognize and incorporate new knowledge of Hepatitis C genetic diversity and epidemiology.
The team made a proposal that Hepatitis C variants be classified into 6 genotypes, representing the 6 genetic groups defined by phylogenetic analysis.
Subtype name assignment will be either confirmed or provisional, depending on the availability of complete or partial nucleotide sequence data.
The team plan to leave subtype name assignment unassigned where fewer than 3 examples of a new subtype have been described.
Dr Simmonds' team concludes, "These proposals provide the framework by which the Hepatitis C databases store and provide access to data on the virus."
"The framework will internationally coordinate the assignment of new genotypes and subtypes in the future."
Hepatol 2005: 42(4): 962-73
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Pharmacists Able to Detect 'Hidden' Hepatitis C in Drug Users SourceURL:http://www.prnewswire.co.uk
MANCHESTER, England, September 26 /PRNewswire/ -- New hope is on the way for intravenous drug users who are, unknowingly, suffering from the Hepatitis C Virus (HCV) according to the preliminary results of a pilot project in Lincolnshire to be launched today (Monday, 26 September 2005) at the British Pharmaceutical Conference in Manchester.
A new four month pilot project, commissioned by the Lincolnshire Drug Alcohol Action Team, offered HCV testing to all clients who attended substance misuse services in two pharmacies. The pharmacies were one setting as part of a multi-agency approach for the delivery of HCV antibody testing within different settings.
The results showed that, of those tested, more than a third (32%) tested HCV antibody positive. These clients were referred on to specialist treatment services if required. They were also offered counselling and advice on safer injecting and how to minimise self-harm.
The Hepatitis C Virus (HCV) is a highly infectious blood borne virus. Left untreated it can lead to serious liver disease including cirrhosis and liver cancer and, potentially, can lead to death(1). However, worryingly, symptoms may not present themselves until the disease develops into a chronic infection.
It is thought that the main transmission route of HCV is through the sharing of blood-contaminated drug injecting paraphernalia by intravenous drug users. Previous studies have shown a 30% prevalence rate amongst this group(2). According to the Pharmacy Based Substance Misuse Services Co-ordinator Debbie Newton, who project managed this new initiative on behalf of Lincolnshire NHS, in-pharmacy detection of HCV is vital for this 'hidden' group who may not access any other treatment services.
"Of those clients, who tested HCV positive, they all appear to have contracted the disease within the last two years," she explains. "Thanks to this new project 78% were referred to secondary services for treatment. Failing to detect and treat HCV could have had serious health consequences for these people."
Mrs Newton conclude:, "This pilot project strongly suggests that it is feasible to deliver a new care pathway for HCV sufferers from a community pharmacy setting, directly into a secondary care service."
References
(1) Department of Health. July 2004. Hepatitis C Action Plan for England.
(2) Department of Health. August 2002. Hepatitis C Strategy for England.
More information
In October 2003, the Department of Health allocated GBP1million in support of the National HCV Strategy, to improve the evidence base on prevalence and incidence rates. Lincolnshire Drug Alcohol Action Team (DAAT) made a successful bid.
The pharmacy was just one setting as part of a multi-agency approach for the delivery of HCV antibody testing within different settings. Results are to be compared at a later date.
Project results
61 clients enquired in pharmacies about the HCV antibody testing service. 28 (46%) were tested and 9 (32%) tested HCV antibody positive. 23 (82%) returned for their results. 11 (39%) were aged 20 - 24 years, 7 (25%) aged 25 - 29 years, 9 (32%) aged 30 - 34 years and 1 aged 42 years. Of the 28 (46%) tested, 16 (57%) had previously been tested HCV antibody negative during the past 2 years and 9 (56%) of those have since tested HCV antibody positive. 4 (44%) were female and 5 (56%) were male, with 2 couples identified with both partners being infected. 7 (78%) of the 9 HCV antibody positives consented to onward referral to a specialist consultant.
The British Pharmaceutical Conference is being held Monday 26 - Wednesday 28 September 2005 at the Manchester International Convention Centre. The conference theme is A common vision for health: Linking science with practice.
Distributed by PR Newswire on behalf of Royal Pharmaceutical Society of GB
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Living with the Sleeping Dragon
SourceURL:http://www.stuff.co.nz
The resilience of hepatitis makes it one of the most common conditions in the world. Cushla Managh finds out how the virus lay dormant in one woman's liver for 25 years before emerging to wreak havoc.
It was the 1970s, a time of excess and experimentation. Tess was in her 20s, a party girl who injected heroin a few times to see what the fuss was all about. All fairly harmless, she thought, till 25 years later she discovered she had been harbouring a disease that threatened her health and possibly her life.
Tess (not her real name) had hepatitis C, also known as "the sleeping dragon". Today she's a quiet-living Wellington professional and single mother to a teenage boy, a far cry from hard-living party days, but in 1999 she learned the consequences of her dalliance with hard drugs when she was diagnosed with hepatitis C.
"There was a lot of cheap Mr Asia heroin around in New Zealand in the 70s and a lot of people were experimenting," she says. "I didn't think I could have (hepatitis C) because I'd tried heroin but I wasn't a junkie. Then a friend who'd similarly dabbled had hepatitis C and I thought, `oh God, I'd better get myself tested'."
A positive diagnosis gained her membership of a not-so-exclusive club. It's been estimated that 70,000 New Zealanders have chronic hepatitis B and a further 28,000 have chronic hepatitis C. Both types can be transmitted through blood and body fluids and both can damage the liver, the organ that John Hornell of the Hepatitis Foundation describes as the body's version of a car filter. The liver stores vitamins, sugar and iron, controls the production and removal of cholesterol, clears the body of waste products, makes clotting factors to stop excessive bleeding, removes bacteria from the bloodstream and releases bile to help us digest food. Not surprisingly, we can survive just a day or so if the liver fails.
With chronic hepatitis B or C infection, the liver becomes inflamed and tries to repair itself by forming tiny scars. As it continues to be damaged, scars form and join together, leading to cirrhosis. Blood is unable to flow freely through the heavily scarred tissue.
Hepatitis B is the world's most common serious liver infection, and it's possible to get it by having unprotected sex, sharing needles or by an infected mother giving birth. Most infected adults are able to get rid of the virus, but some adults, and most infected babies and children, will develop a chronic condition. It's regarded as a particularly nasty condition because it's "silent", able to lie dormant for many years before the sufferer actually starts suffering. Hepatitis C, meanwhile, is transmitted by blood, most commonly through the sharing of needles, though it was notoriously passed on through blood transfusions and blood products before New Zealand began routinely screening donated blood for the virus.
The hepatitis B virus is 100 times more infectious than HIV. Mr Hornell says the hepatitis C virus survives just a few hours outside the body, but the hepatitis B virus can stay alive for two to three weeks. A New Zealand study in the 1990s found the virus in dry particles of sand.
The Hepatitis Foundation says the amount of virus required to infect another person is tiny, and it suspects that in the days before vaccination, many hepatitis B infections were the result of playground contact between children with scratches and sores who unwittingly left infected blood on stones and rough surfaces for other children to catch.
Mr Hornell cites another study, in Scandinavia. Cross-country runners with the virus who were near the front of the race found they had to push their way through brambles. They emerged scratched and bleeding – and some of the runners following behind later contracted hepatitis from the brambles. "It's like Russian roulette: you don't know who will get it. There's no way to tell. You can't tell by looking at someone that they have hepatitis B. People can feel healthy. They're still going to work and carrying on, then one day they wake up and feel terrible."
Mr Hornell says most people diagnosed with the virus choose not to tell others, fearing discrimination.
Tess says she thought "bugger" when she found out she had hepatitis C but considered herself fortunate when a biopsy showed the disease had not ravaged her liver despite the intervening quarter of a century. There was also an element of relief, as the diagnosis finally gave her an explanation for the growing fatigue and unshakeable depression she had begun to experience.
In February this year, she began a six-month course of interferon and ribavirin, a new combination of drugs that has a better success rate than earlier forms of treatment for hepatitis C. Once a week, she would inject interferon in a pre-filled syringe into her thigh, and take tablets daily. For six months, it was like having the flu. "During the treatment, you feel terrible. It's really hard. You have extreme fatigue and you feel sick, depressed. I didn't have the strength to put my hands up to wash my hair. A friend of mine who's been on it calls it rat poison."
Tess struggled to hold her life together during this period, looking after her son and going to work as often as she could. Friends and family rallied and provided the Tess and her son with an evening meal every day.
There were good days as well, she says, and it was definitely worth it. After three months' treatment, she was tested for signs of hepatitis C. To her relief, she was clear. However, she had to continue taking interferon for another three months to make sure the virus was gone.
When the six months was up, she was tested again, and again she tested negative for the virus. Tess says that if tests in six months' time show the same result, she is deemed to be cured.
About a fortnight after the last of the interferon left her body, she says, she felt better than she had in years.
"I felt absolute elation and joy, the preciousness of just feeling all right. I felt so grateful to have had this opportunity (for treatment)."
Tess doesn't regret her drug experimentation of the 1970s, saying there's no point, and that many people who, like her who now lead respectable lives, have similarly found that they have been left with the health consequences of what they did in their youth.
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September 27th, 2005
Coley Up on Hepatitis C Trial Start
SourceURL:http://www.businessweek.com
Shares of Coley Pharmaceutical Group Inc. climbed Tuesday after the biopharmaceutical company said it was starting a new early stage clinical study for its hepatitis C treatment Actilon.
Coley shares were up $1.33, or 8.3 percent, to $17.45 in afternoon trading on the Nasdaq at more than seven times their average trading volume. Shares have fallen from a high of $19.30 since going public in August and have rebounded from a low of $15.02 last week.
The study will involve following 60 hepatitis C patients who have failed the standard treatment of pegylated interferon and ribavirin. Patients will be randomly assigned to one of five treatment groups over 12 weeks: Actilon alone, Actilon with pegylated interferon, Actilon with ribavirin, Actilon with pegylated interferon and ribavirin, or just pegylated interferon and ribavirin.
Researchers will assess the safety and tolerability of the drug combinations as well as how far levels of the virus are reduced in the bloodstream. The company expects initial data to be available by the second half of 2006.
Actilon targets structures found on immune cells called Toll-like receptors, which direct the immune system to fight disease.
About 25,000 to 30,000 new cases of hepatitis C are diagnosed in the United States each year, with about 8,000 and 10,000 dying annually from virus complications like cirrhosis or liver cancer.
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Migenix Completes Hepatitis C Treatment Trial
SourceURL:http://news.yahoo.com
Migenix Inc.(OTC: MGIFF.PK, News) said Tuesday it has completed a Phase IIa monotherapy clinical study of celgosivir in development for the treatment of chronic hepatitis C virus (HCV) infections.
The study, according to the San Diego-based company, met its objectives by confirming the drug was well-tolerated with some evidence of antiviral activity in patients with chronic HCV infection.
"The recent celgosivir monotherapy trial in hepatitis C patients indicates that this agent is safe and there appears to be a modest anti-HCV effect. It should be noted that ribavirin monotherapy did not demonstrate a significant anti-HCV effect alone, but in combination with peg-interferon had a dramatic effect with regards to antiviral efficacy. Celgosivir may have a similar or better effect and we are awaiting a combination trial with great interest," Eric Yoshida, M.D., associate professor of gastroenterology at the University of British Columbia and an investigator in the monotherapy study, stated in a release.
This Phase IIa monotherapy trial was designed to test the safety and tolerability of celgosivir in patients chronically infected with HCV and to evaluate viral load changes as monotherapy at different doses. The trial was conducted at six clinical centers in Canada and enrolled 43 patients randomized to receive celgosivir orally at either 200 mg once daily, 200 mg twice daily or 400 mg once daily for twelve weeks. The patients participating in the study were HCV genotype 1 (a difficult-to-treat strain of hepatitis C) who were treatment naive or intolerant to interferon/ribavirin therapy.
The results of the study demonstrate that celgosivir was well-tolerated with generally mild to moderate, reversible side effects, no serious adverse events and some indication of antiviral activity, according to a company statement.
Shares of Migenix were unchanged at .305 cents.
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SciClone to Report Top-Line Data from First U.S. Hepatitis C Phase 3 Trial by Mid-December 2005
SourceURL:http://biz.yahoo.com
SAN MATEO, CA--(MARKET WIRE)--Sep 27, 2005 -- SciClone Pharmaceuticals (NasdaqNM:SCLN - News) today announced that it expects to unblind and report top-line data by mid-December 2005 from the first of its two U.S. phase 3 hepatitis C virus (HCV) clinical trials evaluating its lead compound, ZADAXIN®, as a novel adjunctive treatment for hepatitis C patients who have failed prior therapy. Previously, SciClone planned to unblind the data from both trials together and report these data in the early part of 2006.
"Earlier access to the results from the first trial will provide us with valuable information for the design, prioritization and implementation of additional product development programs, ZADAXIN regulatory plans, marketing strategy and resource allocations," commented Dr. Ira Lawrence, President and Chief Executive Officer of SciClone Pharmaceuticals, Inc. "SciClone is at a very important point in its history, with final data from this first phase 3 trial available to us by mid-December of this year, as well as preliminary data from a phase 2 malignant melanoma trial run by Sigma-Tau by year-end and final data from the second HCV phase 3 trial released in the early part of 2006."
SciClone's two phase 3 hepatitis C trials are designed to determine the benefit of adding ZADAXIN to pegylated interferon alpha to treat hepatitis C non-responder patients. Complementary in design, the first trial enrolled over 500 HCV non-responder patients without liver cirrhosis, while the second trial enrolled over 500 HCV non-responder patients with early liver cirrhosis. Patients in the second trial have completed therapy and will finish their observation period in December 2005. Biopsies for the last patients enrolled in this second trial will be performed by the end of February 2006 and the data from this trial will be reported in the early part of 2006.
"Of course, at this time we cannot predict whether the results from either trial will be favorable or unfavorable," cautioned Dr. Lawrence. "In general, favorable results from both trials would be needed to proceed with the filing of an NDA."
SciClone's two U.S. phase 3 clinical trials are multi-center, randomized and double-blinded studies. All patients in each trial are assigned to a 48-week course of treatment of either ZADAXIN and pegylated interferon alpha or placebo and pegylated interferon alpha. After completing treatment, the patients are followed for a 24-week observation period. The primary endpoints of both trials are the achievement of a sustained virologic response (SVR), defined as the lack of detectable HCV RNA in the bloodstream measured by PCR test 24 weeks after the completion of 48 weeks of therapy, and improvement in liver histology.
About SciClone
SciClone Pharmaceuticals is a biopharmaceutical company engaged in the development of therapeutics to treat life-threatening diseases. SciClone's lead product ZADAXIN® is currently being evaluated in two phase 3 hepatitis C clinical trials in the United States and one hepatitis C triple therapy clinical trial in Europe. ZADAXIN also is being evaluated in other late-stage clinical trials for the treatment of hepatitis B and certain cancers. The company's other principal drug development candidate is SCV-07, currently in phase 1 development, which is being evaluated for the treatment of viral and other infectious diseases. For more information about SciClone, visit www.sciclone.com.
The information in this press release contains forward-looking statements including our expectations regarding the timing of availability of clinical trial data. Words such as "expects," "plans," "believe," "may," "will," "anticipated," "intended" and variations of these words or similar expressions are intended to identify forward-looking statements. Actual results could differ materially and adversely from those expressed in any forward-looking statements as a result of various factors, including unexpected difficulties in compiling or analyzing data, and the availability of information from third parties. as well as other risks and uncertainties described in SciClone's filings with the Securities and Exchange Commission. The availability of phase 3 trial data, even positive data, by itself, does not ensure that the company can successfully file an NDA or ultimately attain regulatory approval.
Contact:
Corporate information contact:
Becky Horner
Investor Relations
SciClone Pharmaceuticals, Inc.
650-358-3437
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Dynavax Introduces TOLAMBA(TM) and HEPLISAV(TM) Brand Names for Ragweed Allergy and Hepatitis B Vaccine Products SourceURL:http://biz.yahoo.com
BERKELEY, Calif., Sept. 27 /PRNewswire-FirstCall/ -- Dynavax Technologies Corporation (Nasdaq: DVAX - News) announced the selection of TOLAMBA(TM) and HEPLISAV(TM) as brand names for its ragweed allergy immunotherapy (formerly, AIC) and hepatitis B prophylaxis products, respectively. Both TOLAMBA and HEPLISAV are in Phase 3 trials. TOLAMBA and HEPLISAV are based on Dynavax's proprietary immunostimulatory sequence (ISS) technology that reprograms the immune system through specific targeting of Toll-Like Receptor 9 (TLR-9) to stimulate an innate immune response. The company believes that TOLAMBA and HEPLISAV are the most advanced TLR-9 agonist-based products in clinical development today.
"We believe that TOLAMBA and HEPLISAV represent potential significant medical advances as well as large commercial opportunities for Dynavax," said Dino Dina, MD, president and chief executive officer. "These first-generation ISS-based products have potential as the foundation upon which we intend to build our allergy and vaccine franchises and to establish Dynavax's leadership in TLR-9-based treatments."
TOLAMBA has been shown to reduce allergy symptoms and the need for other allergy medication in clinical trials to date. TOLAMBA is currently completing a two-year Phase 2/3 clinical trial in adults, and a Phase 3 trial in ragweed allergic children was initiated in June 2005. Dynavax anticipates initiating a pivotal Phase 3 trial in the first half of 2006, pending the outcome of the Phase 2/3 trial and discussions with the US Food and Drug Administration (FDA). Dynavax believes that TOLAMBA represents a potentially new standard of care for the treatment of ragweed allergy. Medical management of seasonal allergic rhinitis is a multibillion-dollar global market. Ragweed is the single most common seasonal allergen, affecting up to 75% of those with allergic rhinitis in the United States, or 30 million Americans. Dynavax believes that a significant market opportunity exists for TOLAMBA in the treatment of ragweed allergic individuals currently undergoing conventional immunotherapy or using multiple prescription or over-the-counter (OTC) medications. In addition, the product may also have the potential to delay or prevent the "allergic march" from allergic rhinitis to asthma.
HEPLISAV has demonstrated statistically significant superior seroprotection in clinical trials to date when compared to the industry standard HBV vaccine, GlaxoSmithKline's Engerix-B®. In June 2005, Dynavax initiated the first of two pivotal Phase 3 trials for HEPLISAV and anticipates initiating a second pivotal Phase 3 trial in early 2006. Dynavax is pursuing a broad clinical and regulatory strategy, designed to demonstrate safety and efficacy of HEPLISAV in multiple age groups. The company's initial commercialization strategies will focus on high-value, underserved populations. These populations include pre-hemodialysis patients, HIV and HCV positive patients, other populations with compromised immune systems as well as professionals in healthcare and law enforcement for whom achieving seroprotection quickly is critical.
About Dynavax
Dynavax Technologies Corporation discovers, develops, and intends to commercialize innovative products to treat and prevent allergies, infectious diseases, and chronic inflammatory diseases using versatile, proprietary approaches that alter immune system responses in highly specific ways. Our clinical development programs are based on immunostimulatory sequences, or ISS, which are short DNA sequences that enhance the ability of the immune system to fight disease and control chronic inflammation. Dynavax's pipeline includes: TOLAMBA, a ragweed allergy immunotherapeutic, currently in a large-scale Phase 2/3 clinical trial, and in a supportive clinical trial in ragweed allergic children; HEPLISAV, a hepatitis B vaccine that is currently in a pivotal Phase 3 clinical trial; a cancer therapy currently in a Phase 2 clinical trial; and an asthma immunotherapeutic that has shown preliminary safety and pharmacology in a Phase 2a clinical trial.
Dynavax cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements, including without limitation all statements related to the therapeutic and commercial potential and development timelines of TOLAMBA and HEPLISAV; statements concerning the company's other clinical programs and its ability to demonstrate the potential of its ISS technology. Words such as "believes," "anticipates," "plans," "expects," "intend," "will," "slated," "goal" and similar expressions are intended to identify forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Dynavax that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Dynavax's business including, without limitation, risks relating to: the outcome of the ongoing Phase 2/3 clinical trial of TOLAMBA and plans to initiate a pivotal Phase 3 clinical trial; the outcome of the ongoing Phase 3 clinical trial of HEPLISAV and plans to initiate a second Phase 3 clinical trial in early 2006; the progress and timing of clinical trials for the company's other products in development; difficulties or delays in developing, testing, obtaining regulatory approval of, producing and marketing its HBV and other products; the scope and validity of patent protection for its products; competition from other pharmaceutical or biotechnology companies; its ability to obtain additional financing to support its operations; its ability to maintain effective financial planning and internal controls; and other risks detailed in the "Risk Factors" sections of Dynavax's Annual Report on Form 10-K filed on March 18, 2005 and Dynavax's quarterly report on Form 10-Q filed on August 9, 2005. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Dynavax undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof.
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September 28th, 2005
Outcomes of Hep C in Latinos and Caucasians
SourceURL:http://www.gastrohep.com
Latinos were infected younger, more frequently HIV coinfected, and more likely to meet criteria for antiviral therapy, however less likely to initiate treatment than Caucasians, finds October's American Journal of Gastroenterology.
The natural history of chronic Hepatitis C and treatment response are different between blacks and Caucasians, but little comparable data is available about Latinos.
Dr Ramsey Cheung and colleagues conducted a cross-sectional secondary analysis in 24 VA medical centers enrolled in a prospective study.
The researchers investigated differences between 421 anti-Hepatitis C-positive, treatment-naïve, Hepatitis C-viremic Latinos and 2510 Caucasians.
Latino ethnicity was associated with early discontinuation of treatment – American Journal of Gastroenterology
The team found that Latinos were infected at a younger age and were less likely to have blood contact during combat, surgery, and needle stick injury.
The research team also noted that Latinos were more frequently HIV coinfected and prior HAV infection.
Latinos were more likely to be treatment candidates, but less likely to actually initiate treatment.
The researchers noted that liver histology showed no difference in fibrosis or fibrosis rate, but steatosis was more common in Latinos.
The team reported that 88 Latinos and 481 Caucasians were subsequently treated with interferon-ribavirin.
Body mass index, duration of infection, baseline tests, liver histology and genotype distribution were similar after interferon-ribavirin.
Compared with Caucasians, the team noted that Latinos discontinued treatment prematurely more often.
The researchers also noted that, compared with Caucasians, Latinos tended to have lower sustained virological response rates.
Multivariate analysis found Latino race and history of recent alcohol use to be associated with early treatment discontinuation.
The researchers found that genotype and viral load but not ethnicity were associated with sustained virological response rates.
Dr Cheung's team commented, "Latinos were infected younger, more frequently HIV coinfected, and more likely to meet criteria for antiviral therapy."
"However, Latinos were less likely to initiate treatment and had a trend toward lower sustained virological responase rates than Caucasians, but not in severity of liver disease."
"Latino ethnicity was associated with early discontinuation but not as an independent predictor of sustained virological response."
Am J Gastroenterol 2005: 100(10): 2186
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AVI BioPharma Initiates Hepatitis C Clinical Trial
SourceURL:http://home.businesswire.com
PORTLAND, Ore.--(BUSINESS WIRE)--Sept. 28, 2005--AVI BioPharma, Inc. (Nasdaq:AVII), today announced the initiation of an exploratory safety and efficacy clinical trial using its proprietary NEUGENE(R) antisense compound AVI-4065. The multicenter study will assess the safety, tolerability, pharmacokinetics and viral response to daily subcutaneous administration of AVI-4065 among healthy volunteers and patients with chronic active hepatitis C virus (HCV).
"There is a large, unmet medical need for effective HCV treatments, as the current treatment regimen is successful in less than half of the patients infected with genotype 1 HCV, the most common form of the virus in the U.S.," said Denis R. Burger, Ph.D., chief executive officer of AVI. "In addition, the de facto treatment regimen of nonspecific antivirals pegylated interferon and ribavirin is expensive, has a plethora of side effects, and is not well tolerated by many patients. The ability of our NEUGENE antisense to specifically target the HCV virus may offer a safer and more efficacious drug for patients."
The multicenter clinical trial will include 80 subjects: 40 healthy adult volunteers in the first phase of the study and 40 patients with chronic active HCV in the second phase. In the first phase, up to four dosage levels will be evaluated to confirm the safety of desired serum drug levels. In the second phase, 40 patients with chronic active HCV will be enrolled, including patients who are drug-naive and patients who have failed conventional interferon and ribavirin treatment. This phase of the trial will assess the safety, tolerability, pharmacokinetics, biological responses and HCV virological effects of AVI-4065 over a minimum of 14 days of treatment. Patients will be monitored following treatment to assess a sustained HCV virological response to AVI-4065.
Mark Holodniy, M.D., F.A.C.P., professor of medicine at Stanford University School of Medicine and director of the Department of Veterans Affairs Public Health Research & Consultation Program located at the Veterans Affairs Palo Alto Health Care System in Palo Alto, Calif., will serve as the principal investigator for the trial. Dr. Holodniy said, "I am pleased to participate as an investigator at one of many study sites in the rigorous clinical testing of AVI's lead compound targeted for the HCV virus. The study should provide a better understanding of the compound's safety, pharmacokinetics, and potential biological effects against HCV."
HCV is a single-stranded RNA virus. Because HCV and other single-stranded RNA viruses have relatively simple genetic structures, they are attractive targets for AVI's NEUGENE antisense, which is designed to target conserved portions of the viral genetic code that are not likely to mutate over time.
About Hepatitis C
Chronic HCV infection causes an inflammation of the liver that can result in the development of cirrhosis, liver cancer or liver failure. According to the World Health Organization, approximately 170 million people worldwide are chronically infected with HCV. It is the most common chronic blood-borne infection in the developed world and the leading cause of liver transplants in the United States. The CDC estimates that approximately 3.9 million Americans have been infected with HCV, of whom 2.7 million are chronically infected.
The Hepatitis Foundation International estimates that between 8,000 and 10,000 people die annually in the United States from HCV-related cirrhosis or liver cancer. The current treatment for HCV, 24 to 48 weeks of therapy with pegylated interferon alpha and ribavirin, is successful in less than half of the patients infected with genotype 1 HCV, the most common form of the virus in the U.S. Furthermore, this treatment has numerous side effects, some of them severe, which make it difficult for almost half of initially treated patients to tolerate the recommended dosages and duration of treatment.
About AVI BioPharma
AVI BioPharma develops therapeutic products for the treatment of life-threatening diseases using third-generation NEUGENE antisense drugs. AVI's lead NEUGENE antisense compound is designed to target cell proliferation disorders, including cardiovascular restenosis, cancer and polycystic kidney disease. In addition to targeting specific genes in the body, AVI's antiviral program uses NEUGENE antisense compounds to combat disease by targeting single-stranded RNA viruses, including West Nile virus, hepatitis C virus, dengue virus and Ebola virus. More information about AVI is available on the company's Web site at http://www.avibio.com.
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including, but not limited to, the results of research and development efforts, the results of preclinical and clinical testing, the effect of regulation by the FDA and other agencies, the impact of competitive products, product development, commercialization and technological difficulties, and other risks detailed in the company's Securities and Exchange Commission filings.
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Bradenton Doctor Chips Away at Hepatitis C Virus
http://www.heraldtribune.com/
KATHLEEN MCLAUGHLIN
kathleen.mclaughlin@heraldtribune.com
Medical office runs 10 to 20 drug trials a year
BRADENTON — When Eliot Godofsky started treating viral hepatitis in 1996, about 10 percent to 15 percent of patients could be cured.
After the introduction of some new drugs, that rate is up to 50 percent.
Godofsky likes those numbers, but he knows they could be even better. “HIV is controllable. Hep-C is potentially curable.”
That’s why his Bradenton-based medical office — the nation’s largest infectious disease practice specializing in viral hepatitis — runs 10 to 20 drug trials a year.
Private practice physicians get involved in clinical research for many reasons: money, experience with cutting-edge treatment, access to drugs for patients.
Godofsky says his prime motivator is fundamental: “The benefit to me is to cure people who thought they were incurable.”
The 46-year-old came to Bradenton to join Michael Bach, a pioneer in HIV/AIDS treatment who died of melanoma in 1998.
Bach & Godofsky, M.D. PA, which now employs six other doctors, still staffs the HIV/AIDS clinic that Bach opened in Manatee County. But Godofsky has expanded the scope of the practice and become an expert on viral hepatitis. Part of that includes doing early-stage drug trials, such as the one for Peregrine Pharmaceuticals that began Aug. 29.
He hopes to help find something that will work for the roughly 50 percent of people who don’t respond to treatment, which involves a yearlong course with debilitating side effects.
The virus
The hepatitis C virus is more widespread than HIV, but it gets relatively little attention.
About 4 million people in the United States are infected with hepatitis C, while about 1 million have HIV.
No national fund like the one established by the Ryan White CARE Act for HIV pays for hepatitis drugs. Treatment, not including lab work, costs about $20,000 per year, Godofsky said.
There are a lot of drugs under research for hepatitis C, but there is not a high-profile, independent center testing them head-to-head, said Lisa Ball, executive director of the Hepatitis Resource Network, a doctors education group.
Sharing needles is the most common cause forof the illness, representing 60 percent of new infections. Although commonly associated with illegal drug use, hepatitis crops up unexpectedly in many middle-aged people because the disease can stay in the body for 10 to 20 years without causing anything more than flu-like symptoms, said Michelle May, the nurse practitioner who runs clinical trials for Godofsky.
Some patients trace their risk back to recreational cocaine use, in which they shared straws, May said.
One woman’s only identifiable risk factor was the fact that she was a seamstress. She might have pricked her finger on a needle used by someone else.
A lot of people don’t realize they can be cured. Some go through the treatment, only to find themselves among the “non-responders.”
“The worst part of my job is helping them through 12 months of therapy, then six months later having to call and say, ‘Your virus is back,’” May said.
There are 12 to 15 companies trying to develop new drugs, and many of them contact Godofsky’s office for trials.
Godofsky thought Peregrine’s drug, Tarvacin, looked promising. The small California company realized the antibody treatment it was developing for cancer tumors might work against hepatitis and other viruses.
The Bradenton doctor agreed to the trial because the drug seems to have low toxicity, and it’s a novel approach: Patients will get one intravenous injection of the antibody, which might block the virus from invading liver cells and remove the virus from the body.
Supporting treatment
Godofsky was drawn to research as an intellectual pursuit, but he has become an expert on the ins and outs of using it to support the practice. He gave a presentation on it last year at the annual meeting of the Infectious Diseases Society of America.
Listed among the reasons for doctors to get involved in trials was “cost-effective income production.”
The medical office gets “good” reimbursement for patient visits and lab reviews with limited billing and collections overhead. Doctors spend no time with managed care, Godofsky notes.
One of his tips on setting up a budget for a clinical trial was “do not be afraid to negotiate.”
“Physicians are not usually terrific businessmen,” but can be, Godofsky says.
Research is not a profit center, Godofsky acknowledges, but by using it he can support the staff required to care for the disease.
Treating viral hepatitis requires a lot of patient monitoring and education.
It can also be very complicated. About 10 percent of viral hepatitis sufferers also have HIV. Doctors know little about how the drugs used to treat the two viruses separately might interact.
Making a living at that kind of medicine is difficult, said Ball, the executive director of the Puyallup, Wash.-based Hepatitis Resource Network.
“There’s no procedure, so it’s not particularly well-reimbursed,” she said. “But patients have lots of questions.”
Many doctors don’t want to be involved.
Godofsky is on the board of directors of the organization, which was started in 1997 to raise awareness of hepatitis C among physicians.
Infectious disease doctors proved to be more interested in the disease than liver or intestinal doctors, Ball said. They are used to dealing with trying to get paid for the time they spend consulting, and many, like Godofsky, do it for the intellectual challenge.
Bach is what brought Godofsky to Bradenton: “He had that zest or lust for research.”
After his partner died, Godofsky said, he worked seven days a week, 20 hours each day for the subsequent year and a half. “I kept the research going. I kept the HIV care going. I gradually added more and more doctors.”
Now the seven doctors, including Godofsky, cover the three hospitals in Manatee County and the Michael Bach Treatment Center. They also work with Infectious Disease Associates of Sarasota.
Bach and Godofsky also runs a wound care center and a large outpatient IV clinic. The IV clinic, which is open every day, sees 80 to 100 people each day.
Godofsky estimates that he has a patient base of about 1,000 and that he accepts about 300 new patients a year.
Patients
May, the nurse practitioner who runs trials for Godofsky, does not have to recruit patients, even for early phase trials where the focus is on establishing safe doses, not treatment.
“They clamor to do these phase-one trials,” she said. “They want to make something good out of something bad.”
Fort Lauderdale resident Philip Younger is the kind of patient who would benefit from a breakthrough drug. He’s among the 50 percent who didn’t respond to treatment, even after three courses.
The 56-year-old was diagnosed with the disease in 2000 and soon started treatment: three shots a week of one drug, interferon, and six pills a day of another, ribavirin.
Younger, hurt on his job moving furniture, took work as as telemarketer to accommodate the side effects: headaches, fever, muscle aches and loss of appetite. He went on three medications to counteract the insomnia and depression.
During that time, Schering-Plough came out with an improved drug, he tried that, too. Younger went through 15 months of treatment, but the virus came back six months after the treatment ended.
Younger tried another company’s drug. That didn’t work, either.
“It’s a freaky virus,” he said.
Younger, who now works for a patient advocacy group called Hep-C Alert, said the treatment at least bought time for his liver, which showed no cirrhosis in his latest biopsy.
“I live right, eat right, hope for the best and counsel people on hepatitis,” he said.
Younger said that if he could take the time off work, he would join a trial now.
“I’ve always said I would shoot toothpaste if it would get rid of this virus,” he said.
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Bioenvision's Phase II Trial of Virostat Very Active in Hepatitis C; Phase II Results to Be Presented at UBS Global Life Sciences Conference
SourceURL:http://home.businesswire.com/
UBS Global Life Sciences Conference
NEW YORK--(BUSINESS WIRE)--Sept. 28, 2005--Bioenvision (Nasdaq NM:BIVN) today announced interim results from the ongoing investigator sponsored Phase II clinical study of BIVN-401 (Virostat) in adults with refractory, chronic Hepatitis C Virus infection (HCV). The results will be presented today by Dr. Christopher Wood, Bioenvision's CEO, at the UBS Global Life Sciences Conference in New York.
BIVN-401 was given to 25 patients with genotype 4 hepatitis C who had failed a prior treatment, including interferon in many of the patients. Sixteen (64%) of the patients had cirrhosis. BIVN-401 was given orally for 100 days and measurement of the viral load was made at 50 days.
At 50 days, 22 (88%) patients had shown a reduction in viral load of greater than 70%. Of these responders, 14 (64%) had a clearance of greater than 90%, with 4 responders having complete viral clearance.
7 of the 25 patients have had viral load measured at 100 days. 6 of these patients show continued reduction in viral load and the seventh patient, who had been 1 of the 3 non-responders at 50 days, had a greater than 90% reduction in viral load.
No major adverse events were noted in the trial.
"Virostat is a highly active anti-viral agent and we are delighted with the responses in this difficult to treat group of patients" said Dr. Wood, who added "currently, large-scale trials are designed in developing countries and a regulatory strategy is being planned for Europe and the U.S."
Dr. Wood added, "This continues our pattern of developing drugs that satisfy unmet medical needs and strengthens our portfolio outside of oncology. Demonstrating Virostat's potential against a worldwide disease was an important step".
About BIVN-401 (Virostat)
BIVN-401 (Virostat) has shown broad activity against a range of viruses in vitro, in particular envelope viruses. Bioenvision has worldwide rights to market BIVN-401 as an anti-viral agent.
About Hepatitis C
Hepatitis C (HCV) is a major cause of acute hepatitis and chronic liver disease, including cirrhosis and liver cancer. The WHO estimates 170 million persons are chronically infected and 3 to 4 million persons are newly infected each year. About 80% of newly infected patients progress to develop chronic infection. Bioenvision's clinical study was conducted in patients with genotype 4 HCV which is poorly sensitive to standard interferon and interferon-ribavirin combination (J Viral Hepat. 2005 Jul;12(4):380-5).
About Bioenvision
Bioenvision's primary focus is the acquisition, development and distribution of compounds and technologies for the treatment of cancer. Bioenvision has a broad pipeline of products for the treatment of cancer, including: Clofarabine (in co-development with Genzyme Corporation), Modrenal(R) (for which Bioenvision has obtained regulatory approval for marketing in the United Kingdom for the treatment of post-menopausal breast cancer following relapse to initial hormone therapy), and other products in clinical trials. Bioenvision is also developing Virostat for Hepatitus C and anti-infective technologies, including the OLIGON technology; an advanced biomaterial that has been incorporated into various FDA approved medical devices. For more information on Bioenvision please visit our Web site at www.bioenvision.com.
Certain statements contained herein are "forward-looking" statements (as such term is defined in the Private Securities Litigation Reform Act of 1995). Because these statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Specifically, factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to: risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and in Bioenvision's compounds under development in particular; the potential failure of Bioenvision's compounds under development to prove safe and effective for treatment of disease; uncertainties inherent in the early stage of Bioenvision's compounds under development; failure to successfully implement or complete clinical trials; failure to receive marketing clearance from regulatory agencies for our compounds under development; acquisitions, divestitures, mergers, licenses or strategic initiatives that change Bioenvision's business, structure or projections; the development of competing products; uncertainties related to Bioenvision's dependence on third parties and partners; and those risks described in Bioenvision's filings with the SEC. Bioenvision disclaims any obligation to update these forward-looking statements.
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1 Million Hep C Patients Could Respond to Therapy by 2014
SourceURL:http://www.medadnews.com
NEW YORK, September 27, 2005- In 2004 around 366,000 patients infected with chronic hepatitis C (CHC) responded to pegylated interferon + ribavirin therapy, with 110,000 estimated in the key US market. However recent research by independent market analyst Datamonitor* (DTM.L) predicts that this number could increase three fold globally by 2014 due to increases in the rate of diagnosis and treatment. The most dramatic changes will occur if the new hepatitis C (HCV) protease and polymerase inhibitors reach the market in 2011.
The HCV virus was first characterized in 1989 and for the most part is transmitted by blood-to-blood contact, especially through transfusion (prior to widespread screening) and the sharing of needles among intravenous drug users (IVDUs). The WHO estimates that the average worldwide prevalence of HCV infection is around 3% or 170-200 million people, and variation between regions can be substantial. Areas of low prevalence (1-2.4%) tend to be within richer economies including the US, Japan, most European countries and Scandinavia whereas areas with high HCV prevalence (10%+) are located in Asia and Africa. Egypt is a notable case having a prevalence of 12%, translating into approximately 7.2 million infected individuals.
A hidden ticking time bomb
HCV remains a serious threat to present and future public health. In the US, HCV is the most common blood-bourne viral infection with an estimated 3.9 million individuals infected, 70% of which have chronic infection (1). HCV infection is assymptomatic for 90% of its history, a characteristic that not only hampers epidemiological survey of the disease, but also suggests a large number of individuals are unaware of their infection and are not receiving treatment, says Datamonitor infectious diseases lead analyst Dr John Savopoulos. "Currently 40% of chronic liver disease and 80% of hepatocellular carcinoma (HCC) is estimated to be HCV related, with the virus being the most common cause of liver transplantation in the US."
Because the peak of HCV infection occurred during the 1970s-80s, the rate of patients presenting with HCV associated complications is expected to increase dramatically over the next 10? years. In fact, the US Centers for Disease Control (CDC) projects a four-fold increase in the number of those infected for 20 years with CHC from 750,000 to 3 million individuals from 1990-2015. Studies also suggest liver related mortality due to HCV will increase 180% in this timeframe, with HCV related direct medical costs estimated to reach $10.7billion by 2019. Clearly, better therapies for HCV eradication or those that can regress or stabilize liver disease are desperately needed.
Pharmaceutical companies Roche and Schering-Plough manufacture the latest generation of HCV treatments or pegylated-interferons known as Pegasys (peg-interferon 2a) and PEG-Intron (peg-interferon 2b). When used in combination with the broad-spectrum antiviral ribavirin (RBV), these molecules can eradicate the HCV virus in around 50% of cases. Eradication is defined as a sustained virological response (SVR) where HCV remains undetectable in a patient’s blood 24-weeks after cessation of treatment, Dr Savopoulos says. “Although not exclusively used for HCV treatment, pegylated interferons (and ribavirin) form the bulk of an estimated $2b global market for HCV treatments predicted to grow to around $4b in 2013.” Datamonitor research suggests that in the US 70 “200,000 patients per year receive pegylated interferons for HCV-therapy (compliant with the full course).”
A blunt edged tool, a growing “non responder” pool
The success of HCV combination therapy is highly genotype dependent. SVR is achieved in up to 88% of patients with genotypes 2 and 3 and but only around 48% of those infected with the less responsive "difficult-to-treat" genotypes 1, 4, 5 and 6. Importantly, up to 75% of Americans are infected with genotype 1 which is thought to be more aggressive with regard to disease progression, associated with more severe liver disease and a higher risk for hepatocellular carcinoma. Patients not achieving SVR are known as "non responders" and have few recommended options, Dr Savopoulos says. "Datamonitor estimates there are around 35- 100,000 non-responders to therapy per year in the US, which are predicted to number 1.4m by 2014. Without further intervention this pool will exceed the number of new diagnoses by 2013."
New treatments in the long term?
The limitations of current HCV therapy and the growing non-responder pool provide the necessary stimulus for new product development. Datamonitor estimates there are currently around 22 compounds within clinical development falling into four main classes: the immunomodulators, interferons, small molecule antivirals and host enzyme inhibitors. More importantly, over the last year major manufacturers have openly put money on the table to join the race in finding better treatments. Novartis has established strong relationships with Idenix (NM283, valopicitabine) and Anadsys (Isatoribine, other immune enhancers); Pfizer acquired Idun for the caspase inhibitor IDUN-6556; Roche spent around $150m investing in Pharmasett's HCV compounds (PS-6130); Schering-Plough moved closer to Migenix's Celgosivir (MX-3253) and Gilead have recently entered the fray with GS-9132.
Because most new experimental compounds are at an early stage of development, it is still unclear how they might be used in light of the current standard of care. However Datamonitor's research with leading HCV experts consistently found that new agents will raise current levels of awareness, thus impacting on the current rate of diagnosis and treatment. In some cases with difficult-to-treat patients, specialists might even be delaying current therapy:
"Because as we have new drugs, we will have more opportunities and of course, that's what many patients are waiting for." EU Opinion Leader
"If they, again, have mild disease and very low elevations of LFTs and a bad genotype people are deferring therapy, because I think there's a realization that probably by 2008, 2009 there's going to be some new compounds which do much better." US Opinion Leader
In the US, only 20-25% of all HCV infections are actually diagnosed -- a key obstacle to limiting the impact of the disease, Dr Savopoulos says. "Therefore a key message is that this predicted era of new treatments will in effect bring more patients into the treated pool, allowing more to respond to therapy regardless of whether treatment is significantly enhanced or not."
New uses of pegylated interferons in medium term?
As well as longer term new product launches, there is the possibility that some selected ongoing trials may bring further options that benefit difficult-to-treat HCV patients. Trials such as the HALT-c and COPILOT are investigating the possibility that keeping patients on prolonged interferon or maintenance therapy may reduce progression of liver disease. Other trials, such as the Roche sponsored REPEAT trial will investigate whether patients that fail to respond to PEG-Intron after 12 weeks will respond if treated with Pegasys. Datamonitor's HCV epidemiology model has assessed the possible impact of these events on various disease parameters taking into account comments from HCV experts:
"If this is independent, so interferon alpha acts independently of the viral load, then it [maintenance interferon] may be an option for patients in the next upcoming 5-10 years and this time, we will perhaps need them, the interferon maintenance therapy because we do not already have five drugs to make a combination therapy with antiviral drugs to inhibit the viral replication on a long term basis." EU Opinion Leader
"Also I think you have to say would the patient put up with that [maintenance interferon]. And I think you have to look much more, not just to the benefits, but the problems of toxicity. In the UK, cost of long term interferon is costly, it's a costly drug, and we wouldn't actually be able to pay for it." EU Opinion Leader
The main results from pegylated interferon maintenance and retreatment trials are due in 2007. If positive they should drive further uptake of PEG-Intron and Pegasys which most believe have peaked for HCV use in the key US market after a decline in 2004, Dr Savopoulos says. "Nevertheless Roche, after gaining further indications in HCV/HIV coinfection and chronic hepatitis B (EU and USA), has reported that over the first half of 2005 they maintained their market leadership in pegylated interferon with sales growth of 15%."
"This current data supports Datamonitor's long term outlook that unless a generic pegylated interferon reaches the market and/or a cocktail of safe HCV antivirals proves more effective, the current standard of care is here to stay for a good many years," he says.
* Hepatitis C epidemiology model
(1)NHANES III Datamonitor’s Hepatitis C epidemiology model features patient flow analysis of the HCV population over 10 year forecast period. The model includes segmentation by line of therapy along with quantification of responder, non repsonder and re treatment pools.
Dr John Savopoulos, Datamonitor infectious diseases lead analyst is available for comment
To arrange an interview or for further details regarding the report contact Matthew Dick in the Datamonitor Press Office on + 44 20 7675 7824, or email mdick@datamonitor.com
For US, please call Suzanna Eygabroat on +1 585-374-6326 x17 For Asia-Pacific, please call Denis Mason on +61 2 9006 1526.
Datamonitor plc (DTM.L) is a premium business information company specialising in industry analysis. We help our clients, 5000 of the world's leading companies, to address complex strategic issues. Through our proprietary databases and wealth of expertise, we provide clients with unbiased expert analysis and in-depth forecasts for six industry sectors: Automotive, Consumer Markets, Energy, Financial Services, Healthcare, Technology. Datamonitor maintains its headquarters in London and has regional offices in New York, San Francisco, Sydney, Tokyo, Frankfurt, Shanghai and Hong Kong. See www.datamonitor.com for further details.
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CALIFORNIA: "Officials Step Closer to Needle Exchange"
Fresno Bee
Barbara Anderson
On Tuesday, Fresno County's Board of Supervisors asked health officer Dr. Edward Moreno and health department staff to determine whether intravenous drug use in the county has become a public health crisis. Should Moreno find such a crisis exists, supervisors could declare a public health emergency, a power authorized under a 1999 state law. That would allow the county to legalize needle-exchange programs designed to reduce the spread of HIV and hepatitis C virus (HCV) among injection drug users (IDUs).
Supervisors have previously stopped short of either asking the county health officer to study the issue or approving needle exchanges. But Sup. Henry R. Perea said Tuesday: "It's time for this board for once and all to deal with this issue."
Citing a study showing that Fresno has the highest number of illegal IV drug users per capita of any large, metropolitan US city, a county grand jury report recently asked the board to create a legal needle-exchange program. A county review of that report found Fresno has a large number of IV drug users who are at risk of HIV and HCV. According to the county Department of Community Health, 75 percent of Fresno IDUs are HCV-infected.
The county also agreed with the grand jury's conclusion that needle exchanges do not encourage the use of illegal drugs or increase crime.
At present, the Fresno Needle Exchange illegally distributes needles to drug users once a week near Roeding Park.
On the basis of Moreno's report, supervisors can approve or reject a legal needle-exchange program, said Perea, but they must not turn a blind eye to the illegal exchange that is already occurring. "We cannot have it both ways," he said. "We have to assert a leadership position on this issue."
Moreno said he could submit the report to the board within a month.
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September 29th, 2005
Xtlbio Has Initiated the Phase 1a Clinical Trial of XTL-6865 for the Treatment Of Hepatitis C
Source: XTL Biopharmaceuticals
XTLbio has initiated the Phase 1a clinical trial of XTL-6865 for the treatment of hepatitis C
Rehovot, Israel, 29 September 2005 - XTL Biopharmaceuticals Ltd (“XTLbio”) (LSE: XTL; NASDAQ: XTLB) today announced that it has initiated the Phase1a clinical trial of XTL-6865 for the treatment of hepatitis C (“HCV”). This trial is being conducted under an investigational new drug application (“IND”), filed with the Food and Drug Administration (“FDA”) in April this year. The trial is a multi-center trial and will be conducted in the US and Israel.
XTL-6865 is being developed to prevent HCV re-infection following a liver transplant and for the treatment of chronic HCV disease. XTL-6865 is a combination of two fully human monoclonal antibodies (Ab68 and Ab65) against the hepatitis C virus E2 envelope protein. A single antibody version of this product was tested in a pilot clinical program that included both Phase I and Phase II clinical trials and provided preliminary evidence of anti-viral activity in humans. Michael Weiss, XTLbio’s Chairman, commented: “Earlier this year, we set the initiation of clinical trials with XTL-6865 as a significant corporate milestone for 2005. We are very pleased to have accomplished this milestone, and look forward to the further advancement of this important product in our HCV portfolio”
Contacts:
XTLbio
Jonathan Burgin, Chief Financial Officer Tel: +972 8 930 4440
About XTL Biopharmaceuticals Ltd.
XTL Biopharmaceuticals Ltd. (XTLbio) is a biopharmaceutical company developing drugs against hepatitis. Established in 1993, XTLbio became a public company in 2000 and its ordinary shares are listed on the Official List of the UK Listing Authority and are traded on the London Stock Exchange under the symbol XTL and on the Tel Aviv Stock Exchange, Israel, and ADR’s, representing 10 ordinary shares each, are traded on The NASDAQ Stock Market under the symbol XTLB.
Cautionary Statement
Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the US Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially, and therefore affect interest by investors in our securities, are the following: the results of prior trails with XTL-686are not necessarily indicative of the results we may have in the Phase 1a and 1b trials; and other risk factors identified from time to time in our reports filed with the various regulatory bodies. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not intend to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.xtlbio.com. The information in our website is not incorporated by reference into this press release and is included as an inactive textual reference only.
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Hepatitis C Caring Ambassadors Program Hosts Pearl Health and Music Fair to Raise Hepatitis C Awareness
Source: Hepatitis C Caring Ambassadors
OREGON CITY, OR -- (MARKET WIRE) -- 09/29/2005 -- The Hepatitis C Caring Ambassadors Program (HCCAP) is pleased to announce the upcoming Pearl Health and Music Fair, an event to raise hepatitis C awareness in the Portland metropolitan community. The event will be held October 8, 2005 from 10:00 AM to 6:00 PM in the historic Pearl District at the Natural Capital Center, 721 NW 9th Avenue in Portland. The Pearl Pharmacy has partnered with HCCAP for this event, which will include free hepatitis C counseling and testing, and free hepatitis A and B vaccine for at-risk persons. Information will be also be provided on cardiovascular disease, diabetes, and thyroid health; targeted screening will be available for these conditions for a nominal fee. A free concert will be held during the event on the roof of the Natural Capital Center featuring the local talents of the Lea Krueger Band, Johnnie Ward, Folkrum, and Los Angeles' Kelly's Lot. Free food and beverages donated by local vendors will round out this fun and informative event.
An estimated 174,000 people in Oregon and Washington are among the 3.9 to 4.5 million Americans already infected with the hepatitis C virus (HCV). Hepatitis C is the most common chronic, blood-borne infection in the United States, and is the leading cause of chronic liver disease among Americans. "Hepatitis C has been dubbed 'the silent epidemic' because the majority of people with HCV are unaware of their status. In the absence of a fully funded national and state response to diagnose and assist people with HCV, HCCAP is committed to raising hepatitis C awareness, educating and testing those at risk, and referring people for proper medical care," said HCCAP Manager Lorren Sandt.
Event co-host and owner of The Pearl Pharmacy Rich Silverman notes, "This important event brings together people and organizations committed to creating sustainable health care paradigms based upon education, prevention, and empowerment. We believe that the drugging of a symptom is not a sustainable form of health care. We offer our clients information about health care options that allow them to take control of their own health."
Motivated by concern for the thousands of people affected by the recent hurricanes along the Gulf Coast, HCCAP, The Pearl Pharmacy, and Hep C Aware will host a sister event the evening of The Pearl Health and Music Fair. "In The Key-of-C," a musical concert featuring local musical artists, will be held at the Goble Tavern on Highway 30 in Rainier, Oregon from 9:00 PM to close. Proceeds will benefit the American Red Cross.
For additional information about the Pearl Health and Music Fair or the In The Key-of-C benefit concert, contact Lorren Sandt, 1-877-737-4372 or click here
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Forest Laboratories, Inc. and Cypress Bioscience, Inc. Announce Results of Phase III Study for Milnacipran as a Treatment for Fibromyalgia
Source: PRNewswire
Preliminary Results Support Continuation of Development Program
NEW YORK, September 28, 2005 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. and Cypress Bioscience, Inc. today announced that preliminary top-line results from an 888 patient randomized, double-blind, placebo-controlled pivotal Phase III study support the continued development of milnacipran as a treatment for fibromyalgia (FMS). Although the results did not achieve statistical significance at the p<0.05 level the planned development program for milnacipran, which includes an ongoing Phase III study and a soon to be initiated additional Phase III study by Forest Laboratories, will continue. At this time the Companies have only been able to review initial top-line results and further analyses must be completed in the coming months to confirm these development plans.
Preliminary Study Results
The primary endpoint of this trial was a composite response rate of an assessment of pain as measured by the Patient Experience Diary (PED)(1) and an assessment of overall impression of patient wellbeing as measured by the Patient Global Impression of Change (PGIC)(2). Using the Last Observation Carry-forward (LOCF)(3) analysis, p-value for patients receiving 200 mg per day of milnacipran was 0.058. This result is supportive of continued development of milnacipran as a treatment for fibromyalgia
In an analysis using the FDA-recommended Baseline Observation Carry- forward (BOCF)(4) analysis the p-value for patients receiving 200 mg per day of milnacipran was 0.048. Although the BOCF analysis yielded statistically significant results, the FDA may not accept this as a registration study.
The magnitude of the treatment effect observed in the three-month study results was maintained at the six-month analysis (p=0.053 and 0.067 for LOCF and BOCF analyses respectively), indicating a durable response to milnacipran treatment.
An additional endpoint of fibromyalgia syndrome, which is a composite of the primary endpoint as well as a physical function assessment, was also evaluated. The results of this analysis were not statistically significant compared to placebo at either the three or six month timeframe.
Upon further analysis, the Companies will be in a position to better assess what impact these results will have on the timing of a New Drug Application (NDA).
Tolerability
Milnacipran was generally well tolerated, with the majority of patient withdrawals occurring early in the trial. The adverse event profile was generally consistent with that seen in the previous worldwide experience with milnacipran, as well as in the Phase II trial. The most common adverse events leading to withdrawal among the milnacipran treated patients were nausea 6%, heart rate increase 2%, headache 2%, and depression 2%.
About Milnacipran
Milnacipran is the first of a new class of agents known as norepinephrine serotonin reuptake inhibitors, or NSRIs, which exerts its effect by preferentially inhibiting the reuptake of norepinephrine over serotonin, two neurotransmitters known to play an essential role in regulating pain and mood. It has been approved for the treatment of non-pain indications in 32 countries and has been used safely by more than 3 million patients during more than six years of commercial availability outside the U.S. Milnacipran is being developed for fibromyalgia in the United States market jointly by Forest and its licensor, Cypress Biosciences, Inc
About Fibromyalgia (FMS)
FMS is a chronic and debilitating condition characterized by widespread pain and stiffness throughout the body, accompanied by severe fatigue, insomnia and mood symptoms. According to the of Rheumatology, FMS is estimated to affect six to twelve million people in the United States. FMS is most often diagnosed in the primary care setting and in addition is the second most commonly diagnosed condition in rheumatology clinics in the United States after osteoarthritis. Despite the high prevalence and severity of this syndrome, there are no treatments specifically approved for FMS in the United States or elsewhere. For more information about fibromyalgia, visit http://www.fmsresource.com.
About Cypress Biosciences, Inc.
Cypress is committed to be the innovator and leader in providing products that improve the treatment of Functional Somatic Syndromes, including Fibromyalgia Syndrome (FMS), and other Central Nervous System conditions, such as Obstructive Sleep Apnea (OSA). Cypress' strategy involves acquiring/in- licensing central nervous system active compounds and developing them for new indications.
In August 2001, Cypress licensed from Pierre Fabre Medicament its first product for clinical development, milnacipran. In January 2004, Cypress entered into a collaboration agreement with Forest Laboratories for the development and marketing of milnacipran.
This press release, as well as Cypress' SEC filings and web site at http://www.cypressbio.com, contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 including statements about the potential of milnacipran to treat FMS and our continued development of milnacipran. Actual results could vary materially from those described as a result of a number of factors, including those set forth in Cypress Annual Report on Form 10-K, the most recent Quarterly Report on Form 10-Q and any subsequent SEC filings and including, but not limited to, the fact that because we did not achieve statistical significance on our primary endpoints, that the FDA may not accept this trial as one of the two pivotal trials required for NDA approval, that the FDA may not allow us to use the BOCF analysis and that upon further analysis of this trial, that we and Forest may elect not to continue development of milnacipran.
About Forest Laboratories, Inc.
Forest Laboratories' growing line of products includes: Lexapro(R) (escitalopram oxalate), an SSRI antidepressant indicated for the initial and maintenance treatment of major depressive disorder and for generalized anxiety disorder in adults; Namenda(R)(memantine HCl), an N-methyl-D-aspartate (NMDA)- receptor antagonist indicated for the treatment of moderate to severe Alzheimer's disease; Benicar(R)*(olmesartan medoxomil), an angiotensin receptor blocker indicated for the treatment of hypertension; Benicar HCT(R)(olmesartan medoxomil hydrochlorothiazide), an angiotensin receptor blocker and diuretic combination product indicated for the second-line treatment of hypertension; Campral(R)*(acamprosate calcium), a glutamate receptor modulator, indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation in combination with psychosocial support; and Combunox(TM)(Oxycodone HCl and Ibuprofen), an opioid and NSAID combination indicated for the short-term management of acute, moderate to severe pain. Further information is available at http://www.frx.com.
Except for the historical information contained herein, this release contains "forward-looking statements" within the meaning of the Private Securities Reform Act of 1995. These statements are subject to risks and uncertainties that affect our business, including risk factors listed from time to time in the Company's SEC reports, including the Company's Annual Report on Form 10-K for the fiscal year ended March 31, 2005 and on form 10-Q for the period ended June 30, 2005. Actual results may differ materially from those projected.
* Benicar(R) is a registered trademark of Sankyo Pharma, Inc.; and Campral(R) is a registered trademark under license from Merck Sante s.a.s., subsidiary of Merck KGaA, Darmstadt, Germany.
(1) Patient Experience Diary (PED) is patient self-reported pain data collected via an electronic diary system which asks patients to document random, daily and weekly pain levels
(2) Patient Global Impression of Change (PGIC) is a patient reported periodic assessment of their perception of change in their condition.
(3) Patient Global Impression of Change (PGIC) is a patient reported periodic assessment of their perception of change in their condition.
(4) Baseline Observation Carry-forward (BOCF) is an analysis that requires the patient remain active in the trial to be evaluated for response. If a patient withdraws from the trial for any reason they are classed as a non-responder irregardless of their pain and global scores at the time of withdrawal.
CONTACT: Charles Triano, Vice President, Investor Relations of ForestLaboratories, Inc., +1-212-224-6714, ; or Sabrina Martucci Johnson, Chief Financial Officer of Cypress Bioscience, Inc.,+1-858-452-2323, x131, charles.triano@frx.com sjohnson@CypressBio.com
Web sites:
http://www.frx.com
http://www.cypressbio.com
http://www.fmsresource.com
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Hepatitis Suit
SourceURL:http://www.wowt.com
Doctor fled country
Jury selection is underway in a Fremont, Nebraska civil suit tied to the largest outbreak of hepatitis C in the country.
Ninety nine people contracted the disease while undergoing cancer treatments three years ago. Cheryl Gentry died of liver complications.
"You don't go from one patient to another and reuse a needle," said Jan Nemecek, Gentry's sister.
Gentry was a patient at a Fremont clinic who contracted hepatitis C while undergoing cancer treatment.
"She thought her cancer was back when she started feeling tired again," said Nemecek. "Well, that was hepatitis C.
Gentry died soon after.
Ninety eight other cancer patients also contracted hepatitis C at the same clinic. The doctor, Tahir Ali Javid, leased space in the Fremont area medical center.
Javid has since gone on to improve his career, fleeing to Pakistan and becoming the acting Pakistani minister of health.
This, despite having his medical license revoked by the state of Nebraska in 2003 for negligence in the hepatitis outbreak.
He failed to follow basic infection control procedures and abandoned patients when he fled the country.
Javid's current position within the Pakistani health system causes many people to believe he won't be in court to face malpractice charges.
His nurse, Linda Prochaska is also named in the civil suit, but Nemecek says Javid is ultimately responsible.
"He's taking the easy way out and I think he needs to come back and I think he needs to at least apologize to all the people that lost loved ones or people who are affected now by this hepatitis 'c'," said Nemecek. "I would sure like to talk to him."
Reporter's question: What would you say? "What were you thinking? You have a responsibility when you received your doctorate degree that you have a responsibility to do the best that you possibly can for your patients. What were you thinking?"
Prochaska is accused of using the same saline bag and syringes on multiple patients.
Jury selection began Wednesday. Opening statements are scheduled to begin Monday.
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Greece: Hepatitis C Is on the Rise
SourceURL:http://www.mpa.gr
Thessaloniki
The number of hepatitis C cases in Greece shows a progressive increase as a result of the arrival of immigrants from the former Soviet Union, according to figures presented by Thessaloniki's Papanikolaou Hospital.
Papanikolaou Hospital Gastroenterology Clinic director and Greek Society for the Study of Liver Georgios Kitis stated to ANA-MPA that a total of 550 people sought treatment at outside-patient units in 2004. Twenty of them came from former Soviet Union countries, 30 were Albanian and the rest were Greek.
A total of 250 patients received treatment for chronic hepatitis C, 100 from the former Soviet Union, 10 Albanians and the rest Greek.
Mr. Kitis characterized the hepatitis B virus as a class-related virus because it clearly depends on the people's living standards stressing that 20 years ago the patient percentage was 3.5 to 5, while in the past few years it has dropped to 2.5%. In general, hepatitis C is less common compared to hepatitis B which is more easily transmitted.
The figures on hepatitis C were made public on the occasion of Hepatitis C Day on October 1.
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China's Doctors Not up to Scratch on Hepatitis B
SourceURL:http://news.yahoo.com
BEIJING (AFP) - A majority of Chinese doctors do not have adequate knowledge of hepatitis B and how to treat and prevent the life-threatening viral liver infection.
A survey found that only two-thirds of 290 doctors specializing in infectious diseases were fully aware of hepatitis treatment procedures, the China Daily said Thursday.
Four in five of 334 doctors not specialising in infectious diseases incorrectly thought that hepatitis B was congenital and could not be effectively prevented.
China has an estimated 120 million chronic hepatitis B carriers, equivalent to the combined populations of France and Britain.
Many show no symptoms and do not pose a threat to co-workers, but the huge group of carriers, roughly 10 percent of China's population, are locked out of jobs and suffer discrimination in social life.
Some 52 percent of the patients said they faced discrimination in employment and education.
Hepatitis B is spread through the exchange of bodily fluids, such as contaminated blood, unprotected sex, shared needles and infected mother-to-newborn contact.
Vaccination has proven to be an effective way to stop the spread of the virus.
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RESOURCE's Recovery Resource Center Receives Federal Funding for a Ground- Breaking Substance-Abuse, HIV/AIDS, and Hepatitis Prevention Program
SourceURL:http://biz.yahoo.com/
MINNEAPOLIS, Sept. 29 /PRNewswire/ -- RESOURCE's Recovery Resource Center (RRC) has just received a $1.7 million, five-year contract from the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) to reduce the incidence of substance-abuse, HIV/AIDS, and hepatitis among communities of color and individuals re-entering the community after serving time in correctional facilities.
"This is a ground-breaking project for a number of reasons," said Heidi Kammer, director of RRC services. "First of all, it is innovative because it recognizes that substance abuse, HIV/AIDS and hepatitis are closely related. Second, it is a partnership among three local organizations with demonstrated expertise in different aspects of these problems -- RRC in the area of chemical abuse, Minnesota AIDS Project in HIV/AIDS prevention, and Access Works in hepatitis prevention. Third, the project targets the groups within our community at highest risk for these devastating illnesses. Fourth, the project will bring SAMHSA Rapid HIV Testing to a Minnesota non-clinical setting for the first time."
SAMHSA is funding the Twin Cities HOPE (Health through Outreach & Prevention Education) Project, because research indicates that the Twin Cities metro area is experiencing an increase in HIV/AIDS cases and that communities of color (especially African Americans and American Indians) and re-entry populations are especially at risk of contracting HIV/AIDS and hepatitis.
In addition to the three core partners, the project has commitments from an additional 16 public, private and faith-based organizations, which will be involved in mobilizing various communities to provide education, prevention, testing and treatment services.
Intensive outreach and education will be done through detox centers, chemical-health treatment centers, churches, faith-based organizations, culturally specific organizations, correctional facilities, community events, and street outreach.
"Having five years of funding will permit us to carry out an intensive, broad-based, multi-faceted campaign that can really reduce the incidence of these serious public health issues in our community," Kammer said. "This new project builds on RRC's past work in this area and on the experience and expertise of the Minnesota AIDS Project, Access Works, and many other private, public and faith-based organizations."
RRC is the chemical-health division of RESOURCE -- a multicultural nonprofit organization that provides employment, training, chemical-health and mental-health services to over 13,000 Minnesotans a year. RRC was one of the first chemical-health treatment programs in Minnesota to bring on-site HIV/AIDS education and testing to its clients.
Public, private and faith-based organizations that have committed themselves to be actively involved in the project are the Hennepin County Community Health Department, Ramsey County Public Health Department, Minnesota Department of Human Services Chemical Health Division, Minnesota Department of Health, Minnesota Office of Minority & Multicultural Health, Minnesota Department of Corrections, Minnesota Office of Justice Programs, Council on Crime & Justice: HELP Project, HIV Services Planning Council, The Red Door, Room 111, CUHHC Clinic, Hennepin Council Medical Center, Hennepin County Human Service Department - Chemical Health, Minnesota Council of Churches, and Federal FORUM & Faith-based CALL.
Source: RESOURCE
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World Hepatitis C Awareness Day to Be Observed on October 1
SourceURL:http://www.pharmabiz.com
Our Bureau, Mumbai
Hepatitis C patients from across the world will come together to spread awareness on the disease, by observing October 1, 2005 as Hepatitis C Awareness Day.
The objective of the World Hepatitis-C awareness day is to draw the attention of people towards the gravity of the virus that has emerged as a major global healthcare problem, infecting approximately three per cent of the world’s population.
Hepatitis C, which was once relatively unheard of, today affects 170 million people worldwide and over 10.9 million people in India. Every year the number of those newly infected with the Hepatitis C virus (HCV) is on a rise by three to four million worldwide. National trends indicate a sizeable concentration of Hepatitis C cases in North Eastern India. Among the metros, 4 lakh Delhiites are suffering from Hepatitis C and Mumbai accounts for 3 lakh cases. Gujarat also carries a patient load of 3.37 lakh.
Going by sheer numbers, Hepatitis C has outpaced the HIV/AIDS menace in India. Moreover, approximately 30 percent of HIV patients also simultaneously suffer from Hepatitis C.
The groups at risk for acquiring the disease include, intravenous drug users, haemodialysis patients, and health-care workers with exposure to blood and blood products, transfusion and transplant recipients and people with tattoos.
Dr. Niranjan Banka, Chief of Gastroenterology and Hepatology, Bombay Hospital said, "Screening of blood for the Hepatitis C virus was made mandatory only from 1 June, 2001. Majority of people who have received blood transfusion prior to this period are most vulnerable to get the virus. People from the high-risk groups should be conscientious about Hepatitis C. They must get their blood screened by a liver function test and an anti-HCV test."
Hepatitis C is a blood-born viral infection of the liver that was first identified only in 1989. Few people realise that they are infected as the symptoms are non-specific (such as fatigue) and people tend to become aware when their disease is quite advanced.
Today the most common route of transmission is use of unsterilised needles (such as those used in tattooing and by intravenous drug users) and syringes.
It is the most infectious virus having 50% chronicity and is responsible for large number of patients affected with cirrhosis. If not treated early may require liver transplant or may further develop to liver cancer. It is largely asymptomatic and has a tendency to cause chronic liver disease.
Low levels of awareness about the disease and treatment options do not allow the existing treatment options available to be fully utilised. Also, unlike Hepatitis B there is no known vaccine available to protect a person against Hepatitis C. Since 2001 Government has it mandatory for blood banks to screen the blood for Hepatitis C. Research reveals that only 6% of the blood banks in India screen the blood for hepatitis C.
"Today, with innovations in technology such as pegylated interferon alfa-2a, between to 80-90% of people with Hepatitis C can be successfully treated. Data of four years follow-up has shown that 98% of patients are still disease free. However we believe that first and foremost it is essential to raise awareness and detection to combat the spread of the disease," informed Dr. G. L. Telang, Managing Director, Roche Scientific Company India Pvt. Ltd.
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September 30th, 2005
Failure to Tackle Hepatitis C 'Will Cost UK £8bn'
SourceURL:http://news.scotsman.com/
BRITAIN is the worst country in Europe at treating the deadl | 
