Hoboken, NJ — September 15, 2011 — Anavex Life Sciences Corp. (“Anavex”) (OTCBB: AVXL) will present the most recent data showing the therapeutic potential of ANAVEX compounds in animal models of Alzheimer’s disease at a special symposium of the 34th annual meeting of the Japan Neuroscience Society. The symposium is being held inYokohama,Japan from September 15-17, 2011.
Results obtained with ANAVEX 2-73 and ANAVEX1-41 will be outlined by Dr. Tangui Maurice, CNRS Research Director, Team II Endogenous Neuroprotection in Neurodegenerative Diseases INSERM,UniversityofMontpellier. The Anavex presentation will provide an overview of the neuroprotection induced by ligands activating the sigma-1 chaperone protein in Alzheimer’s disease.
“We are pleased to be presenting data at this time on the disease-modifying potential of ANAVEX 2-73 and its potential dual utility in both amyloid and Tau pathology, which is currently nearing completion of Phase I clinical trials,” said Harvey Lalach, President of Anavex.
In particular, the pathomimetic toxicity induced by oligomeric amyloid 25-35 fragments injected into the brain of mice could be alleviated in several aspects, including cell loss, cellular stress and brain inflammation. The most recent data suggested that ANAVEX 2-73 could alleviate the generation of newly formed amyloid-beta species that are induced in the model and contribute to the formation of senile plaques in the pathology. Moreover, ANAVEX 2-73 also blocked the mechanism involved in the abnormal and hyper-phosphorylation of Tau protein. Tau protein, once abnormally and hyperphosphorylated, can clump together within neurons, creating so-called neurofibrillary tangles, which are associated with poorly functioning neurons and cell death. These two actions, on amyloid beta species seeding and Tau phosphorylation, suggested that the drug could help to decrease the chronic pathological processes and therefore act as a disease-modifying agent.
About the ANAVEX 2-73 Phase I Clinical Trial
This Phase I clinical trial is a randomized, placebo-controlled study to initially test ANAVEX 2-73 as a single, ascending oral dose in healthy male volunteers between the ages of 18 and 55. The trial seeks to determine the maximum tolerated single dose, safety and pharmacokinetics. The primary objective of this trial is to evaluate the safety and tolerability of ANAVEX 2-73 in humans for the first time. The secondary objective is to determine the pharmacokinetic profile of single oral ascending doses of ANAVEX 2-73.
The Phase I clinical trial is being conducted inGermanyin collaboration with ABX-CRO, a clinical research organization that has conducted several Alzheimer’s disease studies, and the Technical University of Dresden.
About Alzheimer’s Disease
While Alzheimer’s disease is most common in people over the age of 65, it can strike adults of any age irrespective of their gender, background or socioeconomic status. According to the Alzheimer’s Association, an estimated 5.4 million Americans are currently living with Alzheimer’s disease. The number of Americans aged 65 and over with Alzheimer’s is estimated to reach 7.7 million in 2030. This represents a 50 percent increase from the 5.2 million Americans aged 65 and older who are currently affected. The Alzheimer’s Association further projects that the number of Americans aged 65 and older who are affected by Alzheimer’s disease may double or triple to between 11 and 16 million by 2050 unless there are developments to prevent or more effectively treat the disease.
About ANAVEX 2-73
ANAVEX 2-73 is the first of a new class of oral drugs being studied to potentially treat Alzheimer’s through disease modification versus only treating its symptoms.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (www.anavex.com) is a specialty pharmaceutical company engaged in the discovery and development of novel drug candidates for the treatment of neurological diseases and cancer. The Anavex proprietary SIGMACEPTOR™ Discovery Platform involves the rational design of drug compounds targeted to specific receptors involved in the modulation of multiple cellular biochemical signaling pathways.
The SIGMACEPTOR™-N program involves the development of novel drug candidates that target neurological and neurodegenerative diseases (Alzheimer’s disease, epilepsy, depression, pain). The company’s lead drug candidates exhibit high affinity for sigma receptors, which have been extensively documented as potentially valuable drug targets and have demonstrated anti-amnesic and neuroprotective properties. A portfolio of back-up compounds to ANAVEX 2-73 are also in development.
Anavex is a publicly traded company under the symbol 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. Forward-looking statements in this press release include that ANAVEX 2-73, is currently nearing completion of Phase I clinical trials, could alleviate the generation of newly formed amyloid-beta species, could help to decrease the chronic pathological processes and therefore act as a disease-modifying agent, and is the first of a new class of oral drugs being studied to potentially treat Alzheimer’s through disease modification versus only treating its symptoms. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug discovery and development, which include, without limitation, the potential failure of development candidates to advance through preclinical studies or demonstrate safety and efficacy in clinical testing and the ability to pass clinical trials so as to move on to the next phase, our ability to retain key employees and our ability to finance development or satisfy the rigorous regulatory requirements for new drugs. Competitors may develop better or cheaper alternatives to our products. 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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