• Cytori Therapeutics Inc., of San Diego, began a Phase I/II trial (ATHENA) of its cell therapy for refractory heart failure resulting from myocardial ischemia. The randomized, double-blind trial of safety and feasibility will enroll 45 patients at six centers in the U.S. who will be randomized to cell therapy or inactive placebo injection. All patients will have adipose tissue removed. The tissue is used for processing into adipose-derived stem and regenerative cells.

• Euthymics Bioscience Inc., of Cambridge, Mass., completed enrollment in the Phase IIb/IIIa study of its lead product candidate amitifadine (formerly called EB-1010), a serotonin-preferring triple reuptake inhibitor for the treatment of major depressive disorder (MDD). The TRIADE (Triple Reuptake Inhibitor Anti-Depressant Effects) study is designed to assess safety and efficacy. A total of 342 MDD patients were randomized at 39 centers in the U.S. Top-line results are expected by the end of the first quarter of 2013.

• Grupo Zeltia, of Madrid, Spain, said its subsidiary Noscira, which is focused on developing treatments for neurodegenerative diseases, disclosed that the primary cognitive endpoint and two of the secondary endpoints were not met in the 26 week ARGO Phase IIb trial. The study evaluated the efficacy of tideglusib vs. placebo plus standard of care for the treatment of mild-to-moderate Alzheimer's disease. Tideglusib, a GSK-3 inhibitor, was relatively well tolerated in the 306-patient study. No new safety concerns were detected.

• Inovio Pharmaceuticals Inc., of Blue Bell, Pa., disclosed Phase I results indicating that its VGX-3100 therapeutic synthetic vaccine is capable of not only driving robust immune responses to antigens from high-risk types of human papillomavirus infection, but that those immune responses displayed a powerful killing effect on cells changed by HPV into precancerous dysplasias. That effect may ultimately contribute to the regression or elimination of cervical dysplasia and cervical cancer. Inovio is currently assessing the ability of its DNA-based VGX-3100 to treat cervical dysplasias caused by HPV infection in a global Phase II trial. Results from the Phase I trial appeared in the peer-reviewed journal, Science-Translational Medicine.

• StemCells Inc., of Newark, Calif., said two papers reporting clinical and preclinical data demonstrating the therapeutic potential of the company's HuCNS-SC cells (purified human neural stem cells) for a range of myelination disorders were published in the Oct. 10, 2012, edition of Science Translational Medicine. One paper described results a Phase I trial in Pelizaeus-Merzbacher disease (PMD), a genetic myelination disorder that afflicts children. In the trial, which was completed in February, four patients were transplanted with the company's HuCNS-SC cells and all showed preliminary evidence of progressive and durable donor cell-derived myelination. Three of the four patients showed modest gains in their neurological function, which suggested a departure from the natural history of the disease; the fourth patient remained stable. The other paper summarized preclinical research, which demonstrated that transplantation of neural stem cells in an animal model of severe myelin deficiency results in new myelin that enhanced the conductivity of nerve impulses.

• Vertex Pharmaceuticals Inc., of Cambridge, Mass., said Phase II data with VX-809 combined with ivacaftor in people with the most common mutation in the cystic fibrosis transmembrane conductance regulator gene, F508del, were presented at the 26th Annual North American Cystic Fibrosis Conference, in Orlando, Fla. Final study results, provided in June, supported Vertex's plans to initiate a pivotal program in early 2013, which is expected to evaluate VX-809 in combination with ivacaftor in people with cystic fibrosis who have two copies (homozygous) of the F508del mutation, pending discussions with regulatory agencies.