December 8, 2005
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As you may recall we've been saying VX-950 is the revolutionary new therapy to watch for HCV. Now it looks like the FDA agrees this treatment is quite promising and deserving of faster approval than a lesser worthy approach. Another reason they are doing this is they know current therapy options are less than ideal.
UPDATE 1-Vertex hepatitis C drug will get fast track review
Thu Dec 8, 2005 11:07 AM ET
BOSTON, Dec. 8 (Reuters) - Vertex Pharmaceuticals Inc. (VRTX.O: Quote, Profile, Research) said on Thursday that U.S. regulators will review its experimental hepatitis C drug on an accelerated basis.
The Cambridge, Massachusetts-based company said the U.S. Food and Drug Administration granted "fast track" status to the drug, VX-950, a designation given to drugs aimed at treating serious or life-threatening conditions.
The drug is currently in early clinical trials and the company won't be ready to submit a marketing application until 2008, according to Joshua Boger, its chief executive officer.
Fast track status will, however, speed the drug's journey to the market as Vertex will have more frequent contact with the FDA, and it will be able to submit data from its clinical trials as it comes in, rather than waiting until the entire package is complete.
Hepatitis C is a liver disease caused by a virus in the blood. It affects about 3.4 million people in the United States.
Vertex's drug is an oral treatment that goes into the blood stream and blocks the HCV protease, a protein the hepatitis C virus makes in the liver cells. Blocking the protein prevents the virus from reproducing.
The company hopes that the drug will dramatically shorten the time it takes to eliminate the virus from the blood stream. Current treatments typically take a year to reduce the virus to undetectable levels and only work in about 50 percent of patients.
The current standard of care is a combination of pegylated interferon and ribavirin. Vertex plans to test its drug in combination with pegylated interferon next year.
Posted by Ralph at 7:10 PM --- Printer-friendly version
December 2, 2005
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It is always good to see progress with alternatives to current medical therapy for HCV. Even though companies that are working on solutions to be used with interferon are not really offering anything groundbreaking or revolutionary, it does continue the evolution of treatment.
The fact that Valopicitabine is nearing Phase III studies is certainly notable. No other seems to be that far along.
Idenix Provides Update on Clinical Development Program for Valopicitabine (NM283) for the Treatment of Hepatitis C
CAMBRIDGE, Mass., Dec. 2 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc., (Nasdaq: IDIX), announced today that the company met with the United States Food and Drug Administration (FDA) on November 30, 2005 to discuss the clinical development program for valopicitabine (NM283) for the treatment of hepatitis C.
Based upon this meeting, the company anticipates finalizing the study design for a phase III clinical trial in treatment-refractory patients by the end of the first quarter of 2006 and starting to enroll patients thereafter. At the meeting, the FDA requested additional information from the two ongoing phase IIb clinical trials evaluating valopicitabine. In response, Idenix plans to provide the FDA with comprehensive 24-week data from the ongoing phase IIb clinical trial in treatment-refractory patients.
Idenix also expects to provide initial data from the ongoing phase IIb trial evaluating valopicitabine in treatment-naive patients, which includes a patient cohort receiving valopicitabine 800 mg plus pegylated interferon beginning on day 1 of treatment. This is the treatment regimen that the company currently expects may be evaluated in phase III clinical trials. The company anticipates that it will provide in January 2006 these additional data that have been requested and thereafter meet with the FDA to review such additional data.
At that meeting, the company anticipates further discussing with the FDA the proposed phase III clinical trial protocol. "We are pleased with the interaction we have had with the FDA to date regarding valopicitabine development," said Jean-Pierre Sommadossi, chief executive officer of Idenix. "We are optimistic that we will continue to advance the valopicitabine clinical program, particularly in view of the serious unmet need in the treatment-refractory patient population in hepatitis C," he said.
About Valopicitabine
Valopicitabine, which is administered orally once a day, is intended to block HCV replication by specifically inhibiting the HCV RNA polymerase, the enzyme that makes new copies of HCV viral chromosome inside infected cells. Initial phase I clinical trials sponsored by Idenix showed that valopicitabine is active in patients infected with the genotype 1 strain of HCV, the strain that infects the majority of patients in North America, Europe, and Japan. The ongoing clinical trials are designed to evaluate the combination of valopicitabine and pegylated interferon in hepatitis C genotype 1 patients who previously failed to respond to antiviral treatment, as well as in genotype 1 patients who have not been treated previously. Preliminary results from phase II clinical trials to date have demonstrated that the antiviral effect of valopicitabine is enhanced when this agent is used in combination with pegylated interferon.
About Hepatitis C
Hepatitis C is an infectious liver disease caused by the hepatitis C virus. The World Health Organization estimates that 170 million individuals worldwide carry chronic HCV infection, with 3 to 4 million new infections occurring globally each year. It is the most common chronic blood-borne infection in the United States, with 2.7 million people chronically infected. Chronic HCV infection causes inflammation of the liver, which may cause progressive liver damage that can lead to liver scarring, liver cancer, liver failure, and death. Patients infected with HCV genotype 1 are difficult to treat, with half or fewer such patients achieving sustained responses to current standard treatment regimens involving a combination of pegylated interferon plus ribavirin. These "non-responders" or treatment-refractory patients comprise a growing patient population, who have no proven alternative treatments available and who are at risk for progressive HCV-associated liver disease. As the prevalence of severe liver disease attributable to chronic hepatitis C rises, deaths due to complications from hepatitis C infection, currently 8,000 to 10,000 per year in the United States, are expected to increase dramatically over the next 15 to 20 years.
About Idenix
Idenix Pharmaceuticals, Inc. is a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral and other infectious diseases. Idenix's current focus is on the treatment of infections caused by hepatitis B virus, hepatitis C virus and human immunodeficiency virus (HIV). Idenix's headquarters are located in Cambridge, Massachusetts and it has drug discovery and development operations in Montpellier, France and drug discovery operations in Cagliari, Italy. For further information about Idenix, please refer to http://www.idenix.com.
Posted by Ralph at 5:42 PM --- Printer-friendly version