• DOV Pharmaceutical Inc., of Somerset, N.J., reported preliminary analysis of Phase Ib results of DOV 21,947, its lead triple reuptake inhibitor for depression and obesity, indicating that the drug was safe and well tolerated at the doses examined and produced a significant decline in plasma triglyceride levels. The study enrolled 46 subjects to receive either escalating doses of 50 mg, 100 mg and 150 mg of DOV 21,947 (31 subjects) or placebo (15 subjects) for eight weeks. Based on those data, the company plans to initiate a 200-patient Phase II study in depression in the fourth quarter.

• ImClone Systems Inc., of New York, said it started enrolling patients in a European Phase II study of IMC-11F8, a fully human IgG1 monoclonal antibody to the epidermal growth factor receptor. The study will involve a total of 40 patients with treatment-naïve locally advanced or metastatic colorectal cancer to design the efficacy and safety of IMC-11F8 administered every two weeks by intravenous infusion in combination with mFOLFOX-6 (5-FU/FA/oxaliplatin) therapy.

• Iomai Corp., of Gaithersburg, Md., said interim results from a Phase I safety and immunogenicity trial of its patch-based vaccine for travelers' diarrhea found that all subjects who received the vaccine mounted an immune response. The trial compared the number of people 65 and older who seroconverted with the number of participants ages 18 to 40 who seroconverted. All subjects who received the patch, regardless of age, seroconverted with IgG antibodies. Also, 18 of 19 elderly subjects and 15 of 17 adult subjects also seroconverted with IgA antibodies. The study was conducted in Belfast, Ireland, and subjects received two patches, 21 days apart, containing "heat labile" toxin and were followed for 42 days. No treatment-related serious adverse effects were reported.

• Sirtris Pharmaceuticals Inc., of Cambridge, Mass., initiated a Phase Ib clinical trial of SRT501 in patients in Europe with MELAS Syndrome (Mitochondrial Encephalopathy Lactic Acidosis and Stroke-like episodes). MELAS is a progressive and fatal disorder caused by a mutation in the DNA of the mitochondria that mainly affects muscles and nerves leading to reduced exercise capacity and eventually muscle failure. There currently are no known treatments. The trial is designed to test the primary endpoints of safety and pharmacokinetics in patients with MELAS. SRT501 will be administered to 15 patients once daily for three months, and an additional group of 15 patients will receive placebo. Secondary endpoints include exercise tolerance and fasting blood glucose and insulin levels. Sirtris expects data from the trial by the end of 2008.

• Spectrum Pharmaceuticals Inc., of Irvine, Calif., said the FDA has cleared the investigational new drug application for the use of SPI-1620 in patients with recurrent or progressive carcinoma. SPI-1620 is being developed as an adjunct to chemotherapy. It is a highly selective endothelin-B agonist that has demonstrated in experimental animal models a 300 percent transient and selective increase in blood flow to tumors and an increased delivery of anticancer drugs to the tumor while sparing normal tissues and organs. The Phase I trial will be an open-label, dose-escalation study assessing the safety, tolerability, pharmacokinetics and pharmacodynamics in patients with recurrent or progressive carcinoma.