• Aeterna Zentaris Inc., of Quebec City, said perifosine, its oral AKT inhibitor, combined with temsirolimus was well tolerated in an investigator-driven Phase I trial in recurrent or progression malignant glioma. The study, which involves 32 patients with recurrent or progression glioma, anaplastic astrocytoma, anaplastic oligodendroglioma and transformed low-grade gliomas, currently is accruing to dose level five after two dose-limiting toxicities in the dose level seven group and dose level six group. Maximum tolerated dose has not been defined. Preliminary survival results demonstrated that median overall survival was 7.4 months, with two partial responses, 13 reports of stable disease and 12 reports of progressive disease. Data were presented at the Neuro-Oncology meeting in Washington.

• Diffusion Pharmaceuticals LLC, of Charlottesville, Va., said it completed a Phase I trial of lead compound trans sodium crocetinate (TSC) in nine patients with newly diagnosed primary glioblastoma (GBM), and a safety monitoring committee authorized immediate open enrollment for a follow-on Phase II trial. That study will explore TSC's effects on tumor regrowth, patient quality of life and overall survival in GBM patients when dosed in conjunction with conventional radiation therapy. The Phase II study will enroll a total of 50 patients, with a target date of complete enrollment by early 2013. TSC has orphan designation in GBM.

• Genentech Inc., of South San Francisco, a member of the Roche Group, reported results from the Phase III AVAglio study showing that Avastin (bevacizumab) in combination with radiation and temozolomide chemotherapy improved progression-free survival by 36 percent vs. radiation and temozolomide plus placebo (p > 0.0001) in patients with newly diagnosed glioblastoma. Data, however, showed the co-primary endpoint of overall survival (OS) failed to reach statistical significance (p = 0.2135). Final OS data are expected in 2013. Results were presented at the Society for Neuro-Oncology meeting in Washington.

• Nymox Pharmaceutical Corp., of Hasbrouck Heights, N.J., said recruitment will begin for NX02-0022, an open-label study of NX-1207, the firm's Phase III-stage drug for benign prostatic hyperplasia. The study will enroll about 100 to 200 subjects who previously participated in earlier NX-1207 trials and will assess the safety and efficacy of repeat injection of the drug. The trial will run concurrently with the pivotal studies.

• Xenetic Biosciences plc, of London, said it started a Phase I/IIa trial of MyeloXen, a vaccine candidate aimed at treating multiple sclerosis (MS). The three-part, open-label trial will include a total of 26 subjects. Part one will comprise six healthy volunteers, while part two will involve 10 patients for a dose-escalation phase and part three will dose 10 patients at the dose levels determined in part two. Parts two and three will involve patients with relapsing, remitting and secondary progressive MS. The endpoint is to demonstrate safety and tolerability and provide data on surrogate efficacy and mechanism of action.