• Aastrom Biosciences Inc., of Ann Arbor, Mich., said it plans to pursue a Phase III program for its autologous cell therapy in critical limb ischemia through the FDA's special protocol assessment process. The firm is completing a Phase IIb trial in CLI.

• Biothera, of Eagan, Minn., reported Phase Ib/IIa data showing that the combination of its Imprime PGG immunotherapy and Erbitux (cetuximab, Eli Lilly and Co. and Bristol-Myers Squibb Co.) doubled the historical overall response rate and time to progression of second- and third-line metastatic colorectal cancer patients treated with Erbitux monotherapy. The 22-patient second arm of the study showed a response rate of 24 percent for the Imprime PGG plus Erbitux group, with a stable disease rate of 38 percent and progression-free survival of 12 weeks. That compares to historical Erbitux-only data showing an 11 percent response rate, a 22 percent stable disease rate and PFS of six weeks. Data were presented at the European Society for Medical Oncology's World Congress on Gastrointestinal Cancer in Barcelona, Spain.

• Capstone Therapeutics, of Tempe, Ariz., completed a limited analysis of subset data from its ongoing AZX100 Phase IIa trial in trocar site scarring following arthroscopic shoulder surgery and said the study will continue to its planned 12-month endpoints. The primary endpoint is the 12-month POSAS score, with secondary endpoints including a series of independently-analyzed, validated, objective measurements of the scar throughout the 12-month post-surgical period.

• Curis Inc., of Cambridge, Mass., said licensee Debiopharm SA, of Lausanne, Switzerland, treated the fifth patient in its ongoing Phase I trial of Debio 0932, a small-molecule heat-shock protein 90 inhibitor. Under the terms of the companies' 2009 agreement, Curis will receive a $3 million milestone payment. The Phase I trial is testing Debio 0932 as a single agent in patients with advanced solid tumors or lymphoma.

• DBV Technologies, of Paris, said the FDA accepted its investigational new drug application for clinical testing of Viaskin Peanut for the desensitization to peanut allergy. Objectives of the first trial are to demonstrate safety and tolerability in both adult and pediatric patients and to determine an appropriate dosing regimen for further trials. The company expects to start recruiting patients this month.

• Genmab A/S, of Copenhagen, Denmark, reported interim results from a Phase II study of atumumab, its CD20-targeting antibody, in relapsing-remitting multiple sclerosis, which showed no dose-limiting toxicities, no unexpected safety findings and rates of infection that were comparable between the drug and placebo groups. The 38-patient study also showed statistically significant reductions in the number of brain lesions, as measured on serial MRI scans from week eight to week 24, in the ofatumumab group vs. placebo. Full results from the trial are expected later this year.

• SymBio Pharmaceuticals Ltd., of Tokyo, started a Phase II trial of bendamustine hydrochloride (SyB L-0501) in previously untreated multiple myeloma patients in Japan. Patients will receive the drug in combination with prednisolone. SymBio previously submitted a new drug application in Japan for refractory and relapsed indolent non-Hodgkin's lymphoma and mantle cell lymphoma. Bendamustine is sold in the U.S. by Cephalon Inc., of Frazer, Pa., under the brand Treanda for NHL and chronic lymphocytic leukemia.