Aeterna Zentaris Inc., of Quebec City, reported that an article on final data for the phase I portion of the ongoing phase I/II trial in prostate cancer with zoptarelin doxorubicin (formerly AEZS-108), a hybrid molecule composed of a synthetic peptide carrier and doxorubicin has been published in the December 2014 issue of Clinical Cancer Research. The article outlines data previously disclosed in June 2013, which demonstrated the compound’s safety profile and promising anti-tumor activity in heavily pretreated men with castration- and taxane-resistant prostate cancer. These results led to the current investigator-driven phase II portion in this same indication. The phase II experiment includes up to 37 patients with pretreated castration- and taxane-resistant prostate cancer, using the dose selected (210 mg/m2) in the phase I portion. The primary endpoint is to evaluate the clinical benefit of zoptarelin doxorubicin for these patients. Clinical benefit will be defined as non-progression at 12 weeks with no dose-limiting toxicity or other toxicity requiring termination of treatment.
Athersys Inc., of Cleveland, concluded patient enrollment of its phase II study involving administration of Athersys’ Multistem cell therapy to ischemic stroke patients. The study is a randomized, double-blind, placebo-controlled, multicenter trial evaluating the safety and efficacy of Multistem therapy in subjects suffering moderate to moderate-severe ischemic strokes. Athersys expects initial results from the study to be disclosed around the end of the first quarter of 2015. The primary endpoints include safety over the first seven days following treatment and global stroke recovery at day 90, which assesses global disability, neurological deficit and activities of daily living.