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October 26, 2005

More HCV Treatment News Coverage

The Los Angeles Times is one of the largest daily newspapers in the U.S. Their interest in HCV is indicative of a growing awareness of the extent of the disease in this country.

The article clearly focuses on the hope of safer, more effective treatments than what is now available.

Science & Medicine | Los Angeles Times Examines Study Results of Three Experimental Hepatitis C Treatments

[Oct 25, 2005]

More than 24 hepatitis C treatments currently are in development, and at least three drugs are demonstrating the potential to prevent the virus from replicating, the Los Angeles Times reports. "These drugs are more potent and have much less side effects" than treatments that currently are available, Eugene Schiff, director of the Center for Liver Diseases at the University of Miami, said.

One drug, called valopicitabine -- which is manufactured by Cambridge, Mass.-based Idenix Pharmaceuticals and is currently in more advanced clinical trials than other experimental hepatitis C therapies -- works by blocking the action of RNA polymerase, an enzyme the virus needs to replicate. In a study of 79 patients conducted last year, the once-a-day pill reduced hepatitis C viral levels by up to 90% after two weeks of treatment, even though 87% of the trial's participants had received previous treatments that failed to reduce their viral loads. The interim results of another valopicitabine trial -- which involved 190 hepatitis C patients not helped by conventional treatment regimens -- are scheduled to be released in November. Preliminary results of that trial show a decrease in viral reproduction, according to the Times. Nathaniel Brown, chief medical officer at Idenix, said that valopicitabine likely will be part of a combination therapy, "but we're in a race against time because the number of people with advanced disease is steadily increasing."

Two other experimental hepatitis C drugs recently have completed early stage clinical trials: SCH-503034, made by Schering-Plough, and VX-950, made by Cambridge, Mass.-based Vertex. Both treatments target the protease enzyme, which the virus uses to reproduce. Results from a Shering study on SCH-503034 are expected to be released in November, and Shering liver expert Janice Albrecht said that the decrease in viral levels was "significant." A study conducted this year of VX-950 involving 34 volunteers showed that after two weeks of treatment, the medication proved 250 times as powerful as conventional medication in reducing hepatitis C levels. Researchers are planning additional studies for both drugs (Marsa, Los Angeles Times, 10/24).

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October 19, 2005

Japanese Researchers Make Progress

This article is from one of the largest Japanese newspapers. As it shows, researchers in Japan are also working hard to develop a better treatment for HCV.

Scientists the world over are doing their best to find a less toxic and more effective treatment.

Possible breakthrough on hepatitis C
10/18/2005

The Asahi Shimbun

A Japanese research team said it has found a method that prevents the multiplication process of the virus for hepatitis C, a chronic disease that could lead to fatal disorders like cirrhosis and liver cancer.

The method deals with cells infected with the virus, not the virus itself, meaning that drugs could be developed to stop the multiplication process while preventing the virus from becoming resistant.

It is still unknown how exactly the hepatitis-C virus (HCV) multiplies once inside human cells. But researchers know that once the virus enters the cell, it develops a platform for multiplication by combining itself with a certain lipid, an organic compound.

The team at Chugai Pharmaceutical Co., led by Masayuki Sudo, determined a point inside cells where the HCV combines itself with the lipid.

Without the platform, the HCV is unable to duplicate itself, the researchers said.

Using human liver cells, the team added a substance to the lipid that prevented it from combining with the HCV. Thus, the platform for multiplication could not synthesize, the researchers said.

"If we can target the mechanism of virus-infected cells, it could prompt the development of more effective drugs," Sudo said.

The team's report was to be published on the Web site of the U.S. science journal Nature Chemical Biology on Monday.

An estimated 1 million to 2 million are infected with hepatitis C in Japan.

"HCV is troublesome because of its many mutations," said Takaji Wakita, a senior researcher at the Tokyo Metropolitan Institute for Neuroscience. "If we can target something that is contained in the cells, we may be able to come up with drugs that would prevent the virus from developing resistance. We need to make sure of the side effects, including the possibility that the treatment could affect other cells."(IHT/Asahi: October 18,2005)

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October 05, 2005

VX-950 Making Progress

Here's an exciting one, VX-950 we've been watching for a while. This protease inhibitor is making good progress (and is orally administered, no less).

While being studied as another Interferon treatment enhancer, it could be very helpful if it replaced Ribavirin. We understand Ribavirin is what causes the most toxic responses to current therapy.

New Data Suggest Vertex's Oral Hepatitis C Virus Protease Inhibitor VX-950 May Reduce Liver Injury; VX-950 Clinical Milestones on Track

MONTREAL, Oct. 3 /CNW/ -- New data show that patients with genotype 1 hepatitis C virus (HCV) infection treated with VX-950, an investigational oral HCV protease inhibitor being developed by Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX), rapidly achieved substantial reductions in alanine aminotransferase (ALT) levels after 14 days of treatment.

The findings were presented today by researchers at the 12th International Symposium on Hepatitis C and Related Viruses (HCV 2005) in Montreal, Canada. Vertex also provided an update on clinical development of VX-950, which is one of the most advanced of a new class of medicines in development for the treatment of chronic hepatitis C infection.

Data from a 14-day clinical study demonstrated that treatment with any one of three doses of VX-950 resulted in median serum ALT declines of 25-32 U/L in all dose groups. In the placebo group, a median 8 U/L increase was observed.

Prior to treatment with VX-950, serum ALT levels were elevated in approximately 70 percent of patients in the study. In the VX-950 dose groups, 83 percent (15 of 18) of patients with elevated ALT levels at baseline (prior to treatment) had achieved normalization of ALT levels at day 14, compared to 0 percent (0 of 6) in the placebo group.

Elevated ALT levels are common in HCV patients and are considered to be a marker of liver injury due to HCV infection. Mean levels of serum neopterin also were observed to decrease with VX-950 treatment in the study. Decreased neopterin levels may be a further signal of a reduction in inflammation associated with HCV infection.(1)

A study of viral isolates from patients at baseline in a 14-day clinical study, also presented at the conference, found heterogeneity among viral sequences in the HCV protease domain. In vitro analysis indicated that all baseline viral isolates were sensitive to VX-950.(2)

"To date, data from early clinical studies have suggested that VX-950 is well-tolerated and can rapidly reduce HCV viral levels in patients over a short treatment period," said John Alam, M.D., Senior Vice President of Drug Evaluation and Approval at Vertex. "In addition, we now have evidence that treatment with VX-950 appeared to lead to a dramatic decline in markers of liver injury associated with viral infection."

Clinical Update Vertex affirmed today that it remains on track to achieve key milestones in its VX-950 clinical program in the fourth quarter of 2005, including initiation of a 14-day Phase Ib combination study of VX-950 and pegylated interferon in Europe and filing of an investigational new drug (IND) application in the United States to support Phase II development of VX-950. Vertex anticipates that it will initiate a 28-day, Phase II combination study of VX-950 and pegylated interferon by year-end. Vertex expects to present additional VX-950 clinical data at two more medical conferences in the fourth quarter of 2005.

Clinical Need and Market Opportunity in HCV Infection

Chronic hepatitis C virus (HCV) infection is a serious public health concern affecting approximately 2.7 million people in the United States. HCV causes inflammation of the liver, which may lead to fibrosis and cirrhosis, liver cancer, and ultimately, liver failure. Cirrhosis of the liver resulting from chronic HCV infection is the leading reason for liver transplantation in the U.S. Due to the asymptomatic nature of HCV infection, it often goes undetected for up to 20 years following initial infection. Worldwide, the disease afflicts as many as 170 million people. Each year, 8,000 to 10,000 people in the U.S. die from complications of HCV infection.

About Vertex

Vertex Pharmaceuticals Incorporated is a global biotechnology company committed to the discovery and development of breakthrough small molecule drugs for serious diseases. The Company's strategy is to commercialize its products both independently and in collaboration with major pharmaceutical companies. Vertex's product pipeline is principally focused on viral diseases, inflammation, autoimmune diseases and cancer. Vertex co-promotes the HIV protease inhibitor, Lexiva(R), with GlaxoSmithKline.

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October 01, 2005

Another Biotech Contender

Here is another compound from a biotech pharmaceutical company. This antisense approach has been spoken of with great promise. We look forward to seeing how it proceeds. We'll stay tuned to this one...

AVI BioPharma Initiates Hepatitis C Clinical Trial

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.

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