Gilead Sciences Inc., of Foster City, Calif., said it started enrolling patients in a Phase II trial of its integrase-based, single-tablet, once-daily regimen of elvitegravir, GS 9350 and Truvada (emtricitabine/tenofovir disoproxil fumarate) in HIV. GS 9350 is being developed as a pharmacoenhancing agent to increase blood levels and allow once-daily dosing for certain medicines. The 48-week study is designed to test the regimen against once-daily Atripla, which combines the two medicines in Truvada with Sustiva (efavirenz, Bristol-Myers Squibb Co.), in 75 HIV-1-infected, antiretroviral treatment-naïve adults. The primary endpoint will be the proportion of patients with viral loads less than 50 copies/mL at 24 weeks of treatment, while secondary endpoints will include the proportion of patients with viral loads less than 50 copies/mL at 48 weeks, as well as safety and tolerability.
Hybrigenics SA, of Paris, reported preliminary results from a Phase II trial of inecalcitol in hormone-refractory prostate cancer showing that the drug was well tolerated, with no changes in calcium parameters observed in any of the 42 patients enrolled to date, even at the highest dose of 1,000 mcg/day. The trial is testing inecalcitol in combination with Taxotere chemotherapy. Of the 31 evaluable patients, 27 showed a decrease in prostate-specific antigen levels of more than 30 percent within three months of initiating treatment, for a response rate of 87 percent.
Icagen Inc., of Research Triangle Park, N.C., reported Phase I results showing that ICA-105665 was well tolerated at all dose levels and plasma concentrations in excess of predicted efficacious concentrations were achieved. No serious adverse events, dose-limiting toxicities or dropouts were reported. The drug also appeared to have no effect on the plasma concentrations of other anti-epileptic drugs. Those data were presented at the Antiepileptic Drug Trials conference in Coral Gables, Fla. Icagen is developing ICA-105665 in epilepsy and neuropathic pain. The drug recently was placed on partial clinical hold in epilepsy due to findings of certain high-dose preclinical studies, and the firm is in the process of conduction additional preclinical trials to address concerns raised by the FDA.
Osiris Therapeutics Inc., of Columbia, Md., said it completed enrollment in its pivotal, Phase III trial of Prochymal, a preparation of mesenchymal stem cells, in first-line treatment of acute graft-vs.-host disease. The 190-patient study is designed to evaluate the proportion of patients surviving at least 90 days who achieve a complete response when Prochymal is added to steroid therapy vs. patients receiving steroids alone. Data from that study, as well as from a second pivotal trial, are expected in the second half of this year.