• Aastrom Biosciences Inc., of Ann Arbor, Mich., reported 12-month final results from the RESTORE-CLI Phase II study of ixmyelocel-T in critical limb ischemia patients with no revascularization options, showing that patients in the treatment arm had a 62 percent reduction in risk relative to placebo in the primary endpoint of time to first occurrence of treatment failure (p = 0.0032). The trial enrolled a total of 72 patients assessed at one year of treatment. While the study was not powered to show statistical significance in the secondary endpoint of amputation-free survival, results from a subgroup of 45 patients with wounds at baseline showed a positive trend (21 percent in the ixmyelocel-T group vs. 44 percent for the control event rate, p = 0.0802). Those data were presented at the American Heart Association Scientific Sessions in Orlando, Fla. Top-line data from the RESTORE-CLI study were reported last year. (See BioWorld Today, Nov. 19, 2010.)

• Anavex Life Sciences Corp., of Hoboken, N.J., completed a Phase I single ascending dose trial of Anavex 2-73, the first of a new class of oral drugs being developed to treat Alzheimer's through disease modification rather than focusing on symptomatic improvement. Anavex 2-73 was well tolerated below the 55 mg to 60 mg dose with only mild adverse events in some volunteers. The company plans to begin a multiple ascending dose trial immediately. Last year, Anavex said it hoped to sign a deal around the sigma 1 receptor agonist at the end of Phase I trials or sometime during Phase II testing. Shares of Anavex (OTCBB:AVXL) were up 17 cents Monday, or 10.6 percent, closing at $1.77. (See BioWorld Today, March 15, 2010.)

• Genzyme Corp., the Cambridge, Mass.-based subsidiary of Sanofi SA, said the Phase III CARE-MS II trial met both of its co-primary endpoints. The randomized trial compared Genzyme's Lemtrada (alemtuzumab) head to head with interferon beta-1a in patients with relapsing-remitting multiple sclerosis (MS). Results showed Lemtrada significantly reduced the relapse rate and worsening of disability as compared with Rebif (subcutaneous interferon beta-1a, Merck Serono). Genzyme is developing Lemtrada in MS in collaboration with Bayer HealthCare. While topline results were presented earlier this year, analysis of the full CARE-MS II data is ongoing. Genzyme said it is on track to submit Lemtrada for regulatory review in both Europe and the U.S. early next year. (See BioWorld Today, July 12, 2011, and Oct. 24, 2011.)

• Lentigen Corp., of Gaithersburg, Md., along with the University Hospitals Case Medical Center, Case Western Reserve University School of Medicine, started a Phase I trial of LG631 gene therapy for the protection of hematopoietic stem cells (HSCs) from the dose-limiting toxicity of chemotherapy drug Temodar (temozolomide, Merck & Co. Inc.). HSCs will be isolated from participating glioblastoma patients, transduced with LG631, an altered human-methylguanine methyltransferases gene to make them resistant to Temodar, and then infused back into the patient. Researchers will investigate whether LG631 can improve the tolerance and effectiveness of chemotherapy by preventing damage to bone marrow.

• Opexa Therapeutics Inc., of The Woodlands, Texas, reported that the results of the Phase IIb TERMS trial of Tovaxin have been published in the Multiple Sclerosis Journal. The data, first reported in 2008, showed that Tovaxin was well tolerated, with no serious adverse events, and demonstrated encouraging results in the reduction of the annualized relapse rate and improvement in disease progression in patients with relapsing-remitting multiple sclerosis.

• Pozen Inc., of Chapel Hill, N.C., reported data from a Phase I study showing that PA32540, a combination of 325 mg aspirin and 40 mg immediate-release omeprazole, was associated with greater platelet inhibition when dosed 10 hours apart from Plavix (clopidogrel, Sanofi SA and Bristol-Myers Squibb Co.) compared to synchronous administration of aspirin, clopidogrel and delayed-released omeprazole at day seven (46.5 percent vs. 39.3 percent; p = 0.004). Pozen said the findings are relevant to the treatment of patients with gastrointestinal risk who require dual antiplatelet therapy and gastroprotection. Data were presented at the American Heart Association Scientific Sessions in Orlando.

• Prana Biotechnology Ltd., of Melbourne, Australia, said scientists from Merz Pharmaceuticals GmbH, of Frankfurt, Germany, and the Max Planck Institute presented data showing that PBT2 was able to prevent synaptic toxicity or loss of signal conductivity caused by the formation of amyloid beta oligomers. Data indicated that it may be most beneficial for neuroprotective agents such as PBT2 to be administered to early stage Alzheimer's patients to best maintain synaptic plasticity and function. Data were presented at the Neuroscience 2011 meeting in Washington.

• Probiodrug AG, of Halle, Germany, reported positive topline results of its Phase I single and multiple ascending dose study of PQ912, a glutaminyl cyclase inhibitor being developed to treat Alzheimer's disease. The blinded, placebo-controlled randomized trial, conducted in Switzerland in 100 volunteers, demonstrated that PQ912 is safe and well tolerated.

• SymBio Pharmaceuticals Ltd., of Tokyo, initiated a Phase II trial of bendamustine hydrochloride (Treakisym) in frontline low-grade non-Hodgkin's lymphoma (NHL) and mantle cell lymphoma (MCL) patients in Japan. It also has started Phase II trials in refractory/relapsed intermediate and high-grade NHL and frontline multiple myeloma patients. SymBio received Japanese marketing approval last year for Treakisym to treat patients with refractory/relapsed low-grade NHL and MCL. Bendamustine is marketed as Treanda in the U.S., where it is approved to treat chronic lymphocytic leukemia and relapsed indolent B-cell NHL. SymBio acquired the exclusive right from Astellas Deutschland GmbH to develop and commercialize bendamustine in Japan; it also has exclusive rights to the drug in China, Taiwan, South Korea and Singapore. (See BioWorld Today, Aug. 20, 2008.)

• Vivus Inc., of Mountain View, Calif., said a new analysis from a Phase III long-term safety and efficacy study of avanafil to treat erectile dysfunction found that avanafil was effective in as early as 15 minutes after dosing in 80 percent of all studywide sexual attempts. The data were presented at the 2011 Sexual Medicine Society of North America Meeting in Las Vegas.