• Adeona Pharmaceuticals Inc., of Ann Arbor, Mich., announced that analyses of a clinical study evaluating reaZin, a gastroretentive, sustained-release, once-daily oral tablet formulated from zinc (150 mg) and amino acid cysteine (100 mg) for treatment of Alzheimer's disease, indicated that the older the reaZin treatment patient, the greater the amount of cognitive benefit compared to the placebo patients of the same age. Patients in the study ranged from 52 to 86 years. Adeona said it intends to make reaZin commercially available as a prescription medical food for the dietary management of zinc deficiency associated with Alzheimer's disease.

• Aastrom Biosciences Inc., of Ann Arbor, Mich., said that its RESTORE-CLI trial demonstrated the safety and efficacy of its cell therapy, ixmyelocel-T, in critical limb ischemia. There was statistically significant improvement in time to first occurrence of treatment failure. The assessment took into consideration amputation of the treated limb, all-caue mortality, doubling of wound size from baseline and de novo gangrene. Aastrom will present full data at a medical meeting in the fourth quarter. (See BioWorld Today, Nov 19, 2010.)

• Aldagen Inc., of Durham, N.C., reported that the first subject enrolled in a Phase II trial of the company's ALD-401, a stem cell population derived from a patient's own bone marrow, for the treatment of stroke.

• Celgene Corp., of Summit, N.J., and Acceleron Pharma Inc., of Cambridge, Mass., announced the start of the first part of a Phase II/III study of ACE-011 (sotatercept) for the treatment of chemotherapy-induced anemia in patients with metastatic non-small-cell lung cancer. Celgene will make a $7 million milestone payment to Acceleron.

• iBio Inc., of Newark, Del., reported positive interim results from a Phase I trial of an influenza A/H1N1 vaccine produced by the iBioLaunch platform. The vaccine demonstrated strong induction of dose-correlated immune responses, with or without adjuvant. The Fraunhofer USA Center for Molecular Biotechnology, iBio's research collaborator, sponsored the single-center, placebo-controlled, blinded dose-escalation study to assess the safety, reactogenicity and immunogenicity of different vaccine formulations. Final results are expected to be available by the end of the year.

• MAP Pharmaceuticals Inc., of Mountain View, Calif., is presenting safety data on its Levadex (dihydroergotamine) orally inhaled migraine drug at the 53rd Annual Scientific Meeting of the American Headache Society in Washington this week. MAP has submitted a new drug application for Levadex to the FDA for the potential acute treatment of migraine in adults. Earlier this year, it signed an agreement with Allergan Inc., of Irvine, Calif., to co-promote Levadex in the U.S. (See BioWorld Today, Feb. 1, 2011.)

• Morphotek Inc., of Exton, Pa., began enrollment in a Phase II trial of MORAb-004, a potential first-in-class monoclonal antibody that binds to endosialin/tumor endothelial marker-1. The open-label study will assess the efficacy of MORAb-004 at one of two doses as determined by progression-free survival in patients with metastatic melanoma in Australia, Europe and the U.S. Secondary objectives include assessment of an overall survival benefit and identification of biomarkers to predict efficacy. Morphotek, a subsidiary of Eisai Inc., of Woodcliff Lake, N.J., expects to enroll up to 80 patients who have received at least one previous drug regimen.

• NovaDel Pharma Inc., of Bridgewater, N.J., opened an investigational new drug application with the FDA for Duromist, an oral spray formulation of New York-based Pfizer Inc.'s Viagra (sildenafil) for erectile dysfunction. Shares of Novadel (OTC BB:NVDL) jumped 2 cents, or 24.5 percent, to close at 9 cents.

• NuPathe Inc., of Conshohocken, Pa., presented additional data from a 12-month open-label trial of migraine patch Zelrix (transdermal sumatriptan) at the American Headache Society annual scientific meeting. The drug was well tolerated, and new data showed 51 percent to 68 percent of patients reported headache relief, while 70 percent to 86 percent reported nausea relief. Zelrix is under FDA review with a decision regarding approval expected by Aug. 29.

• Plexxikon Inc., of Berkeley, Calif., which was recently acquired by Tokyo-based Daiichi Sankyo Co. Ltd., announced the initiation of several new trials for BRAF inhibitor vemurafenib (PLX4032). A Phase II melanoma trial is combining the drug with MEK kinase inhibitor GDC-0973, while another Phase I/II melanoma trial is combining it with recently-approved CTLA-4 inhibitor Yervoy (ipilimumab, Bristol-Myers Squibb Co.). A separate Phase II trial will test the drug as a single agent in thyroid cancer patients with the BRAF mutation. (See BioWorld Today, March 2, 2011.)