Independent Research Describes ANAVEX 3-71 as Potent Cognitive Enhancer in Alzheimer’s Disease Models

Data Strengthens Pipeline Including Sigma-1 and Muscarinic Compound ANAVEX 2-73

NEW YORK, Nov. 30, 2015 -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (AVXL), a clinical-stage biopharmaceutical company developing drug candidates to treat Alzheimer’s disease (AD), other central nervous system (CNS) diseases, pain and various types of cancer, announced today the publication of further data for ANAVEX 3-71 (formerly AF710B) in the peer-reviewed scientific journal Neurodegenerative Diseases.  The ANAVEX 3-71 data provides evidence for a positive, more upstream effect on reducing synaptic loss, amyloid and tau pathologies, and neuroinflammation, which is potentially beneficial for the treatment of Alzheimer’s and other neurological diseases.  ANAVEX 3-71 is part of the Company’s pipeline including ANAVEX 2-73 targeting sigma-1 and muscarinic receptors.

“Our preclinical findings for ANAVEX 3-71 demonstrate its significant potential to enhance neuroprotection and cognition via concomitant activation of sigma-1 receptor and M1 muscarinic acetylcholine receptor (M1R), which could be a therapeutic advantage in treating Alzheimer’s and other related protein-aggregation diseases,” said study author Abraham Fisher, PhD.  “Specifically, the study results reveal that ANAVEX 3-71 effects a strong reversal of synaptic loss in hippocampal neurons.  At very low doses, it mitigates cognitive deficits and normalizes major pathological hallmarks in Alzheimer’s disease models indicating that ANAVEX 3-71 exerts a comprehensive disease-modifying effect.  This data adds to the strong foundation of preclinical evidence to support the potential use of ANAVEX 3-71 in Alzheimer's disease and a wide array of other central nervous system diseases.”

“In addition to ANAVEX 2-73, which is currently the subject of an ongoing PART B longitudinal extension of the Phase 2a study, it appears that ANAVEX 3-71 could be a highly effective treatment for Alzheimer’s when compared with competing drugs, including donepezil (Aricept®), the current standard of care,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex.  “Based on the growing body of positive preclinical data, we look forward to continuing to advance ANAVEX 3-71 towards a potential first human clinical trial.”

The results of the preclinical study demonstrate that ANAVEX 3-71:

• Protects post-synaptic dendritic spines and reverses synaptic loss in hippocampal neurons, which are important for learning and memory and their loss may cause cognitive decline in AD.  Results show that ANAVEX 3-71 efficiently rescues mushroom spines via potential activation of sigma-1 receptor/M1R.
• Mitigates cognitive impairments and lessens Alzheimer’s-like pathology in the 3xTg-AD animal model.  Notably ANAVEX 3-71 showed exceptional efficacy in restoring cognitive decline associated with AD and with lessening BACE1, GSK3beta activity, p25CDK5, neuroinflammation, soluble and insoluble Abeta40, Abeta42, accumulation of amyloid plaques and tau pathologies.
• Reverses the cognitive decline induced by the M1R antagonist, trihexyphenidyl via activation of both sigma-1 receptor and M1R.
   

The paper, “AF710B, a Novel M1/ Sigma-1 Agonist with Therapeutic Efficacy in Animal Models of Alzheimer’s disease,” was published in Neurodegenerative Diseases.  It was co-authored by A. Fisher, the inventor of ANAVEX 3-71, and I. Bezprozvanny, L. Wu, D. A. Ryskamp, N. Bar-Ner, N. Natan, R. Brandeis, H. Elkon, V. Nahum, E. Gershonov, F. M. LaFerla and R. Medeiros from the Israel Institute for Biological Research (Ness-Ziona, Israel), the University of Texas Southwestern Medical Center (Dallas, TX), St. Petersburg State Polytechnical University (St. Petersburg, Russia) and the University of California (Irvine, CA), respectively.

Dr. Abraham Fisher is a member of the Anavex Scientific Advisory Board.

About ANAVEX 3-71

ANAVEX 3-71, previously AF710B, is a promising preclinical drug candidate with a novel mechanism of action shown to enhance neuroprotection and cognition in Alzheimer’s disease.  It is a CNS-penetrable mono-therapy that bridges treatment of both cognitive impairments with disease modifications.  ANAVEX 3-71 is highly effective in very small doses against the major Alzheimer’s hallmarks in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies, and also has beneficial effects on neuroinflammation and mitochondrial dysfunctions.

About Anavex Life Sciences Corp.

Anavex Life Sciences Corp. (AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel drug candidates to treat central nervous system (CNS) diseases and various types of cancer. Anavex’s lead drug candidates, ANAVEX 2-73 and ANAVEX PLUS, the combination of ANAVEX 2-73 and donepezil (Aricept®), are currently in a Phase 2a clinical trial for Alzheimer’s disease. The drug combination ANAVEX PLUS produced up to 80% greater reversal of memory loss in Alzheimer’s disease models versus when the drugs were used individually. ANAVEX 2-73 is an orally available drug candidate that targets sigma-1 and muscarinic receptors and successfully completed Phase 1 with a clean data profile. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties in convulsive epileptic animal models, indicating its potential to treat additional CNS disorders, including epilepsy and others. Michael J. Fox Foundation (MJFF) for Parkinson’s Research has awarded Anavex a research grant to develop ANAVEX 2-73 for the treatment of Parkinson’s disease to fully fund a preclinical study, which could justify moving ANAVEX 2-73 into a Parkinson’s disease clinical trial. ANAVEX 3-71, also targeting sigma-1 and M1 muscarinic receptors, is a promising preclinical drug candidate demonstrating disease modifications against the major Alzheimer’s hallmarks in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies, and also with beneficial effects on neuroinflammation and mitochondrial dysfunctions. Further information is available at www.anavex.com.

Forward-Looking Statements

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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