Anavex Receives Regulatory Approval to Initiate Phase 2a Clinical Trial of ANAVEX 2-73 and ANAVEX PLUS for Alzheimer’s disease
NEW YORK – 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.
About ANAVEX 2-73 and ANAVEX PLUS
ANAVEX 2-73 is an orally available small molecule being investigated for the treatment of Alzheimer’s disease. In addition to preclinical data indicating that ANAVEX 2-73 has the potential to prevent, halt and/or reverse the course of Alzheimer’s disease, there was a highly encouraging synergistic effect observed between ANAVEX 2-73 and donepezil (Aricept®). The combined therapeutic, called ANAVEX PLUS, produced up to 80% greater reversal of memory loss in Alzheimer’s disease models versus when the drugs were used individually.
About Alzheimer’s Disease
Today, Alzheimer’s disease remains the largest unmet medical need in neurology. More than 25 million people are currently diagnosed with Alzheimer’s, with the associated cost of care estimated to exceed $200 billion annually. By 2050, the disease is expected to afflict 100 million. Alzheimer’s disease is a neurological disorder generally characterized by memory loss and cognitive decline. A neurodegenerative form of dementia, the disease begins with mild symptoms and becomes progressively worse.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (www.anavex.com) is a clinical-stage biopharmaceutical company engaged in the development of novel drug candidates to treat Alzheimer’s disease, other CNS diseases and various types of cancer. ANAVEX 2-73, an orally available drug candidate developed to treat Alzheimer’s disease through potential disease modification, has undergone an initial Phase 1 human clinical trial and was well tolerated in doses up to 55mg. Results from preclinical studies indicate that ANAVEX 2-73 demonstrates anti-amnesic and neuroprotective properties. A highly encouraging synergistic effect has also been observed between ANAVEX 2-73 and donepezil (Aricept®). The combined therapeutic, called ANAVEX PLUS, produced up to 80% greater reversal of memory loss in Alzheimer’s disease models versus when the drugs were used individually. Anavex is a publicly traded corporation quoted as AVXL.
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
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