• Dendreon Corp., of Seattle, said data from an exploratory analysis of Phase III studies D9901 and D9902A showed a significant correlation between cumulative CD54 up-regulation and survival for patients treated with Provenge (sipuleucel-T), the company's cellular immunotherapy for men with advanced androgen-dependent prostate cancer. Data were presented at the International Society for Biological Therapy of Cancer annual meeting in Los Angeles. Dendreon has submitted two portions of a rolling biologics license application for Provenge, and expects to submit the chemistry, manufacturing and controls section of the BLA before the end of the year.
• Innovive Pharmaceuticals Inc., of New York, enrolled the first patient in a Phase I trial of INNO-305 in acute myelogenous leukemia, myelodysplastic syndrome, mesothelioma and non-small-cell lung cancer. The study is an open-label, fixed-dose trial designed to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of the product. INNO-305 is a WT1 peptide therapeutic vaccine believed to work by stimulating both CD8 and CD4 T cells. It was licensed by Innovive in January 2006 from Memorial Sloan-Kettering Cancer Center in New York.
• Pharmasset Inc., of Princeton, N.J., initiated oral dosing of R7128 in a Phase I trial to assess the drug's safety and pharmacokinetics in healthy volunteers, as well as provide antiviral potency data over 14 days in hepatitis C virus-infected subjects. R7128, a polymerase inhibitor, is a prodrug of PSI-6130, a pyrimidine nucleoside analogue inhibitor that demonstrated positive effects in preclinical studies.
• Vertex Pharmaceuticals Inc., of Cambridge, Mass., saw its shares jump 17.6 percent Friday on data showing that telaprevir (VX-950), its protease inhibitor for hepatitis C virus, succeeded in suppressing both wild-type hepatitis C virus and resistant variants when combined with pegylated interferon in a Phase Ib study. In addition, the company reported that 24 of 26 patients who received telaprevir in two early stage trials had undetectable HCV RNA after receiving follow-on combination therapy with peg-IFN and ribavirin through 24 weeks of treatment. Data were presented at the 57th annual meeting of the American Association for the Study of Liver Diseases in Boston. Vertex's stock (NASDAQ:VRTX) closed at $40.66 Friday, up $6.09.