• Aastrom Biosciences Inc., of Ann Arbor, Mich., received orphan drug designation for its Tissue Repair Cells for use in osteonecrosis. The company is preparing a protocol to evaluate TRCs in osteonecrosis of the hip, and the study will involve the removal of the necrotic tissue from the interior of the deteriorated bone before implanting the tissue-regenerating TRCs into the femoral head. Shares of Aastrom (NASDAQ:ASTM) jumped 24.5 percent, or 44 cents, Thursday to close at $2.23.

• Aradigm Corp., of Hayward, Calif., and APT Pharmaceuticals Inc., of Tucson, Ariz., initiated a Phase II trial investigating aerosolized hydroxychloroquine as an anti-inflammatory treatment for asthma. The study, expected to enroll 100 patients for a three-week treatment period, is designed to evaluate the safety and efficacy of that HCQ formulation administered using Aradigm’s AERx pulmonary delivery system.

• Bioniche Life Sciences Inc., of Belleville, Ontario, received Canadian regulatory approval to begin part one of its Phase III bladder cancer program using its Mycobacterial Cell Wall-DNA Complex (MCC). In this first part, 105 patients will be involved in an open-label study showing the efficacy of MCC as therapy in superficial bladder cancer refractory to Bacillus Calmette-Guerin. The company won similar approval for Phase III testing from the FDA last month. In separate news, the U.S. Department of Agriculture notified Bioniche that data supplied for its E. coli O157:H7 cattle vaccine was not sufficient to support registration. The company said it intends to submit additional study data.

• Oxigene Inc., of Waltham, Mass., completed patient enrollment in a Phase II trial for imageable solid tumors. The trial is being conducted in the U.S. and is designed to evaluate the safety and activity of the triple combination of Combretastatin A4P, the company’s lead therapeutic candidate, combined with chemotherapy agents, carboplatin and paclitaxel. Top-line data should be available later this year.

• Theratechnologies Inc., of Montreal, completed patient enrollment for its first Phase III trial using TH9507 for the treatment of HIV-associated lipodystrophy. The study is evaluating the safety and efficacy of a daily administration of 2 mg of the drug over a 26-week period, with a primary endpoint of a reduction of visceral adipose tissue, which is a risk factor for cardiovascular disease and Type II diabetes. The company expects to release results by the end of the year, with a second Phase III study set to begin in early 2007.

• Transave Inc., of Monmouth Junction, N.J., said the FDA granted SLIT Amikacin orphan drug status for bronchopulmonary Pseudomonas aeruginosa infections in cystic fibrosis patients. SLIT Amikacin, based on the company’s Sustained release Lipid Inhaled Targeting technology, is designed to allow for once-a-day or less-frequent dosing and to provide for sustained release of the antibiotic, with minimal local and systemic side effects.