Clinical Trial Results
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Gilead, Bristol-Myers Report Positive Viral Responses In Hepatitis C Studies

4/19/2012 8:20 AM ET

Gilead Sciences Inc. (GILD: Quote) Thursday reported a positive result for its Phase 2 Electron study examining the once-daily oral agent GS-7977 plus ribavirin. The study in 25 hepatitis C virus or HCV patients recorded RNA levels undetectable in 88 percent after four weeks of completion of treatment. In the pre-market, Gilead shares rose more than 15 percent.

Bristol-Myers Squibb Co. (BMY: Quote) also released interim results from a Phase II study of daclatasvir and GS-7977 and said that analysis of a combination of the two oral, once-daily investigational compounds taken for 24 weeks, with or without ribavirin, achieved a rapid and sustained viral response.

GS-7977 is a nucleotide analog polymerase inhibitor that is currently being studied for the treatment of chronic hepatitis C.

Gilead noted that three patients experienced viral relapse. The study was in treatment-naïve patients with genotype 1 chronic HCV infection, who completed 12 weeks of treatment with the GS-7977-based regimen. GS-7977 was well tolerated and exhibited a favorable safety profile and no patients experienced viral rebound during treatment, the company stated.

Edward Gane, principal investigator of the Electron study said, "These preliminary results suggest that 12 weeks of therapy with once-daily oral GS-7977 and ribavirin may be enough to cure hepatitis C in many genotype 1 patients, including those who are currently not candidates to receive interferon."

Gane added that further investigation of GS-7977 in a variety of patient populations and combinations will be important in assessing the drug's potential as part of an all-oral regimen for hepatitis C.

Gilead also announced interim results from a second Phase 2 trial (Quantum) examining a 12- and 24-week duration of GS-7977 plus RBV in treatment-naïve patients. Twenty-five patients were randomized to the 12-week treatment arm. The company added that GS-7977's overall safety and efficacy profile was consistent with that seen in Electron study.

According to the company, patients in both the studies will continue to be observed to determine sustained virologic response rates at weeks 12 and 24 of follow-up.

Separately, the company reported interim data from a Phase 2 trial (Atomic) examining a 12-week course of treatment with the once-daily nucleotide GS-7977 plus pegylated interferon and ribavirin in treatment-naïve patients with genotype 1 chronic hepatitis C virus infection. The study discovered that 90 percent of patients achieved a 12-week sustained virologic response, defined as maintaining undetectable viral load 12 weeks after the completion of therapy.

Bristol-Myers Squibb released interim results from a Phase II open-label study of daclatasvir and GS-7977, used in treatment of patients with hepatitis C genotypes 1, 2 and 3. The company stated that the analysis of a combination of the two oral, once-daily investigational compounds taken for 24 weeks, with or without ribavirin, achieved a rapid and sustained viral response.

GILD closed Wednesday's regular trading at $46.61 on the Nasdaq. In the pre-market activity, the shares are up 15.32 percent at $53.75.

BMY ended at $33.57 on the NYSE. In the pre-market, the shares rose 2 percent.

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by RTT Staff Writer

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