• Amorcyte LLC, of New York, a NeoStem Inc. company, said it enrolled the first patient in the Phase II PreSERVE trial testing AMR-001, an autologous bone marrow-derived cell therapy enriched for CD34-positive cells, in acute myocardial infarction. The product will be administered five to 11 days post-stent placement in patients diagnosed with an ST segment elevation myocardial infarction with ejection fraction less than or equal to 48 percent, as determined by cardiac magnetic resonance imaging measured after recovery from myocardial stunning. About 160 subjects, ages 18 and older, will be randomized 1-to-1 between the treatment group and a control group.

• Depomed Inc., of Menlo Park, Calif., said it started a Phase II trial of DM-1992, its gastric-retentive, extended-release formulation of carbidopa/levodopa, in patients with advanced Parkinson's disease with motor fluctuations. The study is expected to enroll up to 45 patients and will test DM-1992 dosed twice daily against a generic version of immediate-release carbidopa/levodopa dosed as needed. The primary endpoint is change in "off" time, as measured by patient self-assessment and clinician assessment.

• Gilead Sciences Inc., of Foster City, Calif., said it started a Phase II trial of GS-7430, a prodrug of tenofovir, the active agent in Viread (tenofovir disoproxil fumarate), in HIV-1 infection in treatment-naïve adults. The study will evaluate GS-7340 as part of a once-daily, co-formulated single-tablet regimen that will also contain the boosting agent cobicistat, the integrase inhibitor elvitegravir and Emtriva (emtricitabine) and will compare that regimen to Gilead's Quad single-tablet regimen containing Viread and Emtriva (as Truvada), elvitegravir and cobicistat. A total of 150 patients will be randomized in the 48-week trial, which will measure the proportion of patients with viral load less than 50 copies/mL at 24 weeks as the primary endpoint. Gilead plans to start a second Phase II trial of GS-7340 later in 2012 that will assess the drug as part of another single-tablet regimen containing cobicistat, Emtriva and Prezista (darunavir) from Tibotec Pharmaceuticals, a unit of New Brunswick, N.J.-based Johnson & Johnson. Gilead inked a deal with Tibotec in November.

• Marina Biotech Inc., of Bothell, Wash., said it will begin enrolling patients in the next several weeks in the second cohort of the dose-escalation phase of the START-FAP (Safety and Tolerability of An RNAi Therapeutic in Familial Adenomatous Polyposis) trial of CEQ508. The first drug candidate to emerge from the firm's transkingdom RNA interference platform, CEQ508 is being developed as an orally administered treatment to reduce the levels of beta-catenin protein in the epithelial cells of the small and large intestine.

• MediGene AG, of Martinsried, Germany, is starting a clinical formulation study aimed at developing an optimized oral formulation of the active substance in RhuDex suitable for treating chronic diseases. Results from the study are expected around the middle of this year. MediGene is developing RhuDex, a CD80 antagonist, as a disease-modifying drug in autoimmune disorders such as rheumatoid arthritis.