New York, NY – November 3, 2014 – Anavex Life Sciences Corp. (“Anavex” or the “Company”) (OTCQB: AVXL), announced today that it has received regulatory approval from the Ethics Committee in Australia to initiate a Phase 2a clinical trial of its proprietary compound, ANAVEX 2-73, as well as ANAVEX PLUS, the combination of ANAVEX 2-73 and donepezil (Aricept®). The approved Phase 2a clinical trial is the first study of ANAVEX 2-73 in Alzheimer’s patients. The investigational compound targets sigma-1 and muscarinic receptors, which have been shown in preclinical studies to reduce stress levels in the brain and to reverse the pathological hallmarks observed in Alzheimer’s disease. Patient screening and enrollment will now commence. Results are expected in 2015.
“The approval is a major milestone for Anavex. We believe it signifies the acceptance of the state-of-the-art methodologies we have incorporated into our clinical trial, which include both adaptive trial features and population pharmacokinetics. The Company’s innovative trial design allows us to capture and maximize key information about ANAVEX 2-73 in the most efficient way,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “This is an exciting time for our Company given the properties of ANAVEX 2-73 and the vast unmet medical needs for Alzheimer’s disease.”
The Phase 2a study is designed as a randomized trial, with enrollment of 32 mild to moderate Alzheimer's disease patients at up to 7 sites. Its adaptive design stipulates that data be collected at a number of intervals, including at 3 and 6 months. This provides the opportunity for modification of one or more detailed aspects of the study based on analysis of data. It is believed this advantage will allow the trial to more efficiently demonstrate the effects of the drug. The trial will focus on the following key endpoints: bioavailability, dose finding and dose response, cognitive efficacy, and the relationship of ANAVEX 2-73 as a potential effective add-on therapy to donepezil, the current standard of care.
Additional information regarding the trial, including enrollment criteria and site information, is available from the U.S. National Institutes of Health (NIH) clinical trials database at www.clinicaltrials.gov.