Biotech Values

[DewDiligence]

Vertex hepatitis C drug effective in small study

[“Effective” may be an understatement here: VX-950 + Pegasys produced a 5.5-log reduction in viral load (a 300,000-fold reduction)!]

http://yahoo.reuters.com/financeQuoteCompanyNewsArticle.jhtml?duid=mtfh39800_2006-01-09_14-32-45_n09...

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Mon Jan 9, 2006 09:32 AM ET

NEW YORK, Jan 9 (Reuters) - Vertex Pharmaceuticals Inc. ( VRTX ) on Monday said a small study showed its experimental hepatitis C drug, in combination with another common treatment, proved significantly better than either medicine alone in reducing levels of the virus in the blood.

The biotechnology company said six of eight patients who received its VX-950 protease inhibitor in combination with pegylated interferon reached a level of the hepatitis C virus that was too small to measure after just 14 days [!].

By comparison, only one of eight patients who received the Vertex drug alone achieved such a level of the virus in that time, while none of the four patients taking the interferon drug alone did so.

The company said it expected to begin a three-month, mid-stage trial of the drug combination involving more than 200 patients in the next few months.

"These data show that VX-950 in combination with pegylated interferon produced a very rapid viral response in each of these patients, who are historically the most difficult to treat effectively," Dr. Henk Reesink, the study's lead investigator, said in a statement.

Current two-drug treatments for hepatitis C often must be taken for three months before half the patients reach undetectable levels of the virus, Vertex said.

The early-stage clinical trial involved 20 patients with the hardest-to-treat genotype 1 strain of the liver disease.

The eight patients in the combination arm received 750 milligrams of VX-950 in pill form every eight hours along with the standard dose of Roche Holding AG's pegylated interferon drug, Pegasys. Pegylated interferon is interferon encased in a fat molecule called polyethylene glycol, which slows the metabolism of the drug in the body and allows for less frequent dosing.

No VX-950 patients in the study reported serious adverse side effects, Vertex said.

"The data announced today provide further support for VX-950's potential to transform the standard of care in hepatitis C virus," Vertex Chief Executive Joshua Boger said.

The Vertex drug alone eradicated 99.99 percent of the virus in the blood, while the combination reduced viral levels by 99.9997 percent, the Cambridge, Massachusetts-based company said.

"That sounds like the same number, but when you're trying to wipe out a virus every nine is tough to get," Boger said. [An amusing soundbite.]

Pegasys alone reduced the virus by 90 percent in the study.

In an earlier study of VX-950 alone, half of the patients taking the drug tested negative for the virus after 14 days, although the virus returned to detectable levels in 5 patients a month after the study concluded.

"This really says we can combine those two agents and get what clearly looks like an additive effect or better," Boger said of the new study. If you go after the virus with two different mechanisms, you are much more likely to wipe it out," he added.

Hepatitis C, which affects more than 3 million people in the United States, significantly raises the risk for developing chronic liver disease, cirrhosis, cancer or the need for a liver transplant.
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