• DOV Pharmaceutical Inc., of Hackensack, N.J., completed enrollment in its first pivotal Phase III trial of its analgesic bicifadine in chronic low back pain. The company expects to announce results from the trial during the second quarter.

• Ecopia BioSciences Inc., of Montreal, received a "no objection" letter from the Therapeutics Products Directorate of Health Canada to begin a Phase I trial of its cancer drug, ECO-4601. The trial will enroll up to 30 patients who suffer from one of six types of cancers - glioblastomas, breast, prostate, ovarian, lung and colon - and are refractory to existing chemotherapies.

• Evotec AG, of Hamburg, Germany, completed the single-ascending dose component of the Phase I study of EVT 101, a subtype-specific NMDA receptor antagonist for the treatment of Alzheimer's disease. Results showed that the drug was well tolerated and achieved good exposure levels.

• Geron Corp., of Menlo Park, Calif., said studies show that its small-molecule telomerase activators, TAT0001 and TAT0002, enhance the functional activity of immune cells from HIV/AIDS donors. The research, presented at the Gordon Research Conference in Ventura, Calif., demonstrated that the activators not only increased the proliferative capacity of cytotoxic (CD8+) T cells and their ability to produce a virus-fighting molecule, gamma Interferon, but also improved the ability of CD8+ cells from HIV-positive donors to inhibit virus production in infected CD4+ T cells.

• Oxigene Inc., of Waltham, Mass., plans to begin a Phase II trial of its lead candidate, Combretastatin A4P (CA4P) in combination with concurrent chemoradiotherapy in patients with all histological types of unresectable Stage IIIa/IIIb non-small-cell lung cancer. CA4P is a vascular disrupting agent designed to disrupt the molecular engagement of VE-caherin and inhibit the associated (beta)-catenin/AKT signaling pathway.

• Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., reported positive preliminary results from an ongoing Phase I dose-escalation study of its vascular endothelial growth factor (VEGF) Trap eye formulation in 18 patients with wet age-related macular degeneration. Data indicate that patients have shown rapid, substantial and prolonged (up to at least four weeks) reductions in retinal thickness, as measured by optical coherence tomography. Results were presented at the Angiogenesis 2006 symposium in Miami.

• Zonagen Inc., of The Woodlands, Texas, reported positive top-line results from an open-label study of its testosterone deficiency drug, Androxal, designed to evaluate the drug's effect on the testosterone level of 13 men with normal, borderline or low testosterone. After two weeks of receiving daily, oral dosages of 25 mg of Androxal, all study subjects exhibited average testosterone levels within the normal range, and at four weeks after the dosing period concluded, all subjects had returned to their baseline levels. Zonagen is conducting a 200-patient Phase III trial to test two doses of Androxal against placebo.

No Comments