Knobias Clip Report (10-3-2007)

Sumbmited From Knobias ClipReport

VRUS: Hits All-Time High After Ph I Dosing Begins for Hepatitis C Treatment

Shares of Pharmasset Inc (VRUS) soared to an all-time high in Wednesday's session after it began dosing in a Phase 1 study of R7128 in combination with Roche's Pegasys(R)(pegylated interferon) and Copegus(R)(ribavirin) for patients chronically infected with hepatitis C virus (HCV) genotype 1, the most difficult to treat form. R7128 is classed as a nucleoside polymerase inhibitor, a new generation of antivirals being developed to treat HCV patients, and it has been shown to lower the level of the virus in patients who failed to respond to interferon therapy. After completing 28 days of the triple combination regimen and a follow-up period of 4 weeks of Pegasys plus Copegus, all patients will then receive 40 weeks of open-label standard of care dosing under a separate protocol.

Dr. Michelle Berrey, Pharmasset's Vice President, Clinical Development & Chief Medical Officer. "R7128 has demonstrated the most potent antiviral activity of any investigational nucleoside HCV polymerase inhibitor to date. All doses of R7128 studied have been generally safe and well-tolerated. The 28-day endpoint of this study will provide meaningful data on early viral kinetics and the proportion of patients who have undetectable HCV RNA by the end of this treatment period. We look forward to sharing the preliminary results of this combination study in the first quarter of 2008."

It is estimated that nearly 180 million people worldwide, or approximately 3% of the world's population, are infected with hepatitis C virus. The CDC has reported that almost 4 million people in the United States have been infected with HCV, of whom 2.7 million are chronically infected.

Genotypes 1, 2, and 3 of HCV are widely distributed throughout Western countries and the Far East (Japan, China, Taiwan, Thailand). Type 4 is predominant in the Middle East and Central Africa. Types 5 and 6 are mainly confined to South Africa and Southeast Asia, respectively. Combination therapy using pegylated interferon and ribavirin has been shown to render the virus undetectable in 50% of patients with genotype 1 and up to 80% with genotypes 2 and 3.

Currently, hepatitis C infection has no cure or vaccine. FDA approved drugs to treat HCV include Roche's Roferon(R) A (Interferon alfa-2a, recombinant) and Ribavirin; Schering-Plough's (SGP) combination therapy of Pegintron(TM)(peginterferon alfa-2b) and Rebetol(R)(ribavirin); Schering's Intron(R) A (Interferon alfa-2b, recombinant) plus Rebetol(R)(ribavirin); and Valeant Pharmaceuticals' (VRX) Infergen(R)(interferon alfacon-1).

HCV drugs in Phase III development for HCV include Sciclone Pharmaceuticals' (SCLN) Zadaxin(R)(thymalfasin or thymosin alpha 1); Valeant's Viramidine(taribavirin); and Human Genome Sciences' (HGSI) Albuferon(R)(albinterferon alfa-2b).

In addition to R7128, Pharmasset is currently developing two other product candidates. Clevudine, an oral treatment for chronic hepatitis B (HBV) infection, is in Phase 3 clinical trials for registration in the Americas and Europe. Clevudine is already approved for HBV in South Korea and marketed by Bukwang Pharmaceuticals in South Korea under the brand name Levovir. Racivir, which is being developed for the treatment of HIV in combination with other approved HIV drugs, has completed a Phase 2 clinical trial.

For the three months ended June 30, 2007, Pharmasset reported a net loss attributable to common stockholders of $0.40 per share, as compared to a net loss attributable to common stockholders of $0.42 per share for the same period in 2006. The Company had an accumulated deficit of $55.5 million and cash and cash equivalents of $65.3 million.



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