• Amgen Inc., of Thousand Oaks, Calif., reported new Phase III data showing that Xgeva (denosumab) treatment significantly increased bone metastasis-free survival compared to placebo and also increased the time it takes to first bone metastasis and the time it takes to develop asymptomatic bone metastases. Amgen said Xgeva works by inhibiting the RANK ligand and preventing cancerous cells from recruiting normal cells to assist in adhering to bone and forming metastatic tumors. Those data were presented at the American Urological Association conference in Washington. Xgeva is under FDA review for use in bone metastasis prevention in prostate cancer.

• BrainStorm Inc., of New York, and Hadasit, the technology transfer company of the Hadassah Medical Organization in Petach Tikvah, Israel, said Israeli regulators approved a Phase I/II study of NurOwn, BrainStorm's autologous stem cell therapy in amyotrophic lateral sclerosis. The trial is designed to establish safety before being expanded to assess efficacy. A total of 24 patients, 12 in advanced stage of the disease and 12 in early stage, will be transplanted with stem cells derived from their own bone marrow and treated with BrainStorm's NurOwn technology. Patients will be followed for six months post-transplantation.

• CureTech Ltd., of Yavne, Israel, and Teva Pharmaceutical Industries Ltd., of Jerusalem, said CT-011 significantly improved progression-free survival (PFS) and overall survival (OS) in a Phase II trial for diffuse large B-cell lymphoma following autologous stem cell transplantation. CT-011, an anti-PD-1 antibody, resulted in a 70 percent PFS rate and an 84 percent OS rate, compared to 47 percent and 62 percent, respectively, for historic controls.

• Cytori Therapeutics Inc., of San Diego, said independent surgeons presented data showing that 19 of 23 patients undergoing adipose-derived regenerative cell fat grafting with the company's Celution system for reconstructive breast surgery reported good to excellent results. The data were presented at the Association of Breast Surgery Conference.

• EnVivo Pharmaceuticals Inc., of Watertown, Mass., said top-line results from a randomized, placebo-controlled Phase IIb trial of EVP-6124 showed the alpha-7 agonist achieved its primary endpoint by significantly improving cognition in schizophrenic patients. Secondary endpoints such as clinical function and reduction of negative symptoms were also improved. EVP-6124 was well tolerated. Detailed data will be presented at an upcoming medical conference.

• Micromet Inc., of Bethesda, Md., published Phase II data showing that blinatumomab produced durable remissions in front-line acute lymphoblastic leukemia. While a 22 percent molecular response rate was expected, 80 percent of patients achieved a complete molecular response, all within the first cycle of treatment. Blinatumomab is an anti-CD19 antibody. The data were published in the Journal of Clinical Oncology.

• TheraVida Inc., of Mountain View, Calif., initiated a Phase II trial of THVD-201 for overactive bladder and urge urinary incontinence. THVD-201 is a combination of tolterodine and a salivary stimulant. The Phase II study will compare THVD-201 to placebo and Detrol (tolterodine, Pfizer Inc.).

• Vivus Inc., of Mountain View, Calif., presented Phase III data showing that avanafil met all the primary endpoints by demonstrating sustained improvement from baseline in erectile function as measured by the Sexual Encounter Profile and improvements in the International Index of Erectile Function. The study also indicated that successful intercourse was achieved as early as 15 minutes, consistent with data from previously reported Phase III trials. Those results were reported at the American Urology Association meeting in Washington.