Pharmasset, Inc, in response to certain inaccuracies in an article published by PharmaWire on May 3, 2010 about its development programme for treatment of hepatitis C virus (HCV) in collaboration with Hoffmann-La Roche Inc. and F. Hoffmann-La Roche Ltd, stated that the development of RG7128 is on track, and that no safety or other concerns have delayed the programme.
More specifically, M Michelle Berrey, chief medical officer, stated, "In discussions with key colleagues at Roche, we have confirmed that the clinical data available on RG7128 to date indicate no concern with the safety profile of the compound. All safety data are reviewed by an independent data monitoring committee (DMC) throughout the conduct of this ongoing phase-IIb trial. While additional studies are necessary and appropriate to assess the safety and efficacy of RG7128, there has been no indication of anemia, bone marrow suppression, or nephrotoxicity, as inaccurately indicated in the PharmaWire article."
Based on the timeline of the PROPEL RG7128 study, almost all of the 408 patients enrolled in the study have already completed their scheduled 8 or 12 weeks of the triple combination portion of the assigned treatment (RG7128 plus standard of care). The last patient enrolled in this study is to receive his or her last dose of RG7128 or placebo in early May.
The development of RG7128 is not on hold or delayed and there are no plans to amend any ongoing protocol to explore lower doses, in refutation of statements in the PharmaWire article.
Paul Lubetkin, executive vice president and general counsel, said, "Pharmasset is troubled that any news organization would issue an article rife with unsupportable and false statements. One of the two named sources in the article confirmed that his statements, which were in the context of an off-the-record discussion about R1626, a Roche nucleoside on clinical hold, were inaccurately reported and misinterpreted as applying to RG7128. The development efforts for RG7128 are on track and ongoing. We sincerely hope that PharmaWire promptly publishes a retraction of this misleading and false article."
Pharmasset is a clinical-stage pharmaceutical company committed to discovering, developing, and commercializing novel drugs to treat viral infections.