• Avicena Group Inc., of Palo Alto, Calif., started a chronic toxicology study of HD-02, its lead candidate for Huntington's disease. The study is expected to conclude during the second half of 2007, at which time Avicena intends to initiate a Phase III trial. HD-02 has orphan drug designation from the FDA.

• Biomira Inc., of Edmonton, Alberta, reached an agreement with the FDA on a special protocol assessment for the planned Phase III trial of Stimuvax for non-small-cell lung cancer. The multicenter, randomized, double-blind and placebo-controlled trial of Stimuvax will be conducted by Merck KGaA, of Darmstadt, Germany, under terms of a licensing arrangement with Biomira. It is expected to enroll about 1,300 patients in more than 250 centers in about 30 countries. The primary endpoint is overall survival.

• Depomed Inc., of Menlo Park, Calif., said a multicenter, double-blind, placebo-controlled Phase II trial involving 147 randomized patients with diabetic peripheral neuropathy demonstrated a statistically significant reduction in average daily pain scores with once-daily Gabapentin GR. Clinically significant improvements were observed with a mean change from baseline to study end of -2.45 compared to -1.26 for placebo (p=0.002). Although not a statistically significant difference for twice-daily Gabapentin GR, there was pain improvement with a reduction in mean daily pain score of -1.75 with Gabapentin GR compared to -1.26 with placebo (p=0.190).

• Genentech Inc., of South San Francisco, said an interim analysis showed that a randomized Phase III study of Avastin (bevacizumab) in combination with interferon alfa-2a therapy in patients with first-line metastatic renal-cell carcinoma met the primary analysis endpoint by significantly improving progression-free survival compared to interferon alfa-2a therapy alone. The early analysis indicated a trend toward improvement in overall survival in the Avastin plus interferon arm. An independent data safety monitoring board has recommended that patients in the study be made aware of the results and offered treatment with Avastin.

• Medicure Inc., of Winnipeg, Manitoba, completed a special protocol assessment agreement with the FDA for the Phase III MEND-CABG II study. The single confirmatory Phase III study will evaluate the cardioprotective effects of the FDA fast-tracked product, MC-1, in about 3,000 patients undergoing coronary artery bypass graft surgery. Study enrollment began in November.

• Northern Therapeutics Inc., of Toronto, and MaxCyte Inc., of Gaithersburg, Md., began the first human trial of an engineered cell-based therapy to treat idiopathic pulmonary arterial hypertension. The first patient in the trial received therapy on Nov. 7, and the procedure was well tolerated. The trial is an open-label, dose-ranging Phase IIa study that will enroll up to 18 patients at two sites in Canada.

• Serono SA, of Geneva, started a Phase III trial to evaluate the effect of two dosage regimens of the new formulation of Rebif (interferon beta-1a 44 mcg, three times a week or once a week) on the time to conversion to multiple sclerosis in people with first clinical symptoms suggestive of the disease. The trial, called the REFLEX study (Rebif Flexible dosing in early MS), will involve 480 patients considered at risk of developing MS because of a recently experienced isolated demyelinating event and of typical magnetic resonance imaging brain scans.

• Valeant Pharmaceuticals International, of Costa Mesa, Calif., plans to initiate a Phase IV study of Infergen, which is in development for daily use in combination with ribavirin in hepatitis C patients who were nonresponsive to previous pegylated interferon and ribavirin therapy. The study will evaluate the use of Infergen plus ribavirin in patients who did not have an optimal response at week 12 of treatment with pegylated interferon and ribavirin.