• MAP Pharmaceuticals Inc., of Mountain View, Calif., said it initiated a randomized, double-blind, placebo-controlled Phase III trial evaluating the efficacy and safety of MAP0004 in treating acute migraine. MAP0004 uses the company's proprietary Tempo inhaler to deliver dihydroergotamine (DHE), which normally is administered by injection. The primary efficacy endpoints will be pain relief, and freedom from nausea, photophobia and phonophobia as measured at two hours after dosing. MAP will also evaluate earliest onset of pain relief and sustained relief to 24 and 48 hours.

• OSI Pharmaceuticals Inc., of Melville, N.Y., announced the initiation of a Phase I trial of OSI-027, an oral, potent and selective inhibitor of both the TORC1 and TORC2 complexes that inhibits the kinase activity associated with mTOR (mammalian target of rapamycin). The study is designed to determine the maximum tolerated dose and to establish the recommended dose and dosing schedule for Phase II trials, and will evaluate the safety and pharmacokinetic profiles of OSI-027 in patients with advanced solid tumors or lymphoma.

• Rib-X Pharmaceuticals Inc., of New Haven, Conn., started a Phase II trial of an intravenous form of RX-3341, a broad spectrum fluoroquinolone antibiotic, in complicated skin and skin structure infections. The study will test two different doses administered to hospitalized cSSSI patients every 12 hours for five to 14 days, as compared to tigecycline (Tygacil, Wyeth). The primary endpoint will measure efficacy, safety and tolerability vs. tigecycline, while secondary endpoints will include clinical efficacy of RX-3341 compared to tigecycline in patients with cSSSIs caused by methicillin-resistant Staphylococcus aureus. Rib-X also reported Phase I results of RX-3341 showing that the intravenous formulation was well tolerated using multiple doses for 14 days.

• Theravance Inc., of South San Francisco, reported positive results from a Phase II study of the GSK961081, which triggered a $10 million milestone payment from GlaxoSmithKline plc, of London. The compound is under development by Glaxo and Theravance as a potential treatment for patients with chronic obstructive pulmonary disease. It was generally well tolerated in the 14-day study with no serious adverse events reported. Theravance also said results from a Phase I study of the safety, tolerability and pharmacokinetics of inhaled long-acting muscarinic antagonist (LAMA), GSK1160724/TD-4208 (TD-4208), for the treatment of chronic obstructive pulmonary disease showed it was generally well tolerated at all doses tested. In addition, TD-4208 showed the potential for 24-hour bronchodilation in COPD patients. Theravance also revealed GSK, which licensed the drug in 2004, recently said it intends to return the LAMA program to Theravance because the current formulation of TD-4208 is incompatible with GSK's proprietary inhaler device. The parties are discussing the transfer of information and materials back to Theravance.

• XOMA Ltd., of Berkeley, Calif., said the results from two ongoing Phase I studies of XOMA 052 in Type II diabetes will be presented at the 44th European Association for the Study of Diabetes Annual Meeting in Rome on Sept. 8. The presentation will examine safety and pharmacokinetics of XOMA 052 in addition to certain markers of activity such as hemoglobin A1c and C-reactive protein. In the two studies, XOMA 052 was well tolerated without any evidence of serious drug-related adverse events.