Athens, Greece — December 17, 2008
Anavex Life Sciences Corp. (“ANAVEX”) (OTCBB: AVXL), a biopharmaceutical company engaged in the discovery and development of novel therapeutics to treat Central Nervous System (CNS) diseases and cancer, announces that the anti-amnesic and neuroprotective effects of ANAVEX 1-41 are detailed in a paper published in the current edition of Neuropsychopharmacology. Currently in the late pre-clinical stage, ANAVEX 1-41 is one of the company’s lead compounds for Alzheimer’s disease (AD).
Neuropsychopharmacology is an international scientific journal and the official publication of the American College of Neuropsychopharmacology, which focuses on clinical and basic science contributions that advance our understanding of the brain and behaviour.
“The ANAVEX 1-41 results highlighted in this important paper clearly demonstrate the compound’s efficacy, which can be attained at extremely low doses, giving us confidence in the likely clinical profile. Furthermore, it highlights the potential for this compound as a therapeutic solution in the fight against Alzheimer’s disease,” said Dr. Vamvakides, Chief Scientific Officer of ANAVEX. “If the results we have achieved in a mouse model are duplicated in human clinical trials we believe that ANAVEX could launch a novel drug for Alzheimer’s with disease-modifying potential through an anti-amnesic and neuroprotective effect. ANAVEX 1-41 may be able to reverse memory and learning deficits and protect nerve cells from death. This is very different from the symptom-alleviating therapies currently on the market.”
A significant factor behind the efficacy of ANAVEX 1-41 is that it can attain synergistic activation of both muscarinic and sigma-1 receptors at extremely low doses in-vivo (0.1 mg/kg i.p.), as evidenced in late pre-clinical studies using a validated mouse model of Alzheimer’s disease. This is the first time these results have been achieved by any pharmacological agent in this non-transgenic Alzheimer’s mouse model, which is created by injecting amyloid-beta (25-35) peptide into mouse brains to bring on histological and biochemical changes, oxidative stress and learning deficits.
The paper describes the exceptional neuroprotective and anti-amnesic benefits of ANAVEX 1-41, one of the company’s lead compounds targeting Alzheimer’s disease. Results achieved in pre-clinical studies to date suggest that ANAVEX 1-41 offers disease-modifying potential through its ability to reverse memory and learning deficits and protect nerve cells from death. Importantly, pre-clinical results also underscore the compound’s ability to prevent oxidative stress induced by Alzheimer’s disease and block apoptosis of neuronal cells through the expression of the caspase-3 enzyme.
The company expects that pre-clinical trials on ANAVEX 1-41 will be complete in early 2009. ANAVEX 1-41 and ANAVEX 2-73, which share a common chemical origin and similarities in their mechanism of action (congeners), are two novel compounds developed by ANAVEX to target Alzheimer’s disease. Both compounds show neuroprotective potential and synergistic effects on muscarinic and sigma-1 receptors at extremely low doses, potentially conveying attractive tolerability profiles in addition to their efficacy. ANAVEX has completed pre-clinical testing in mice on ANAVEX 2-73 and expects Phase 1 human clinical trials to begin in 2009.
The article in Neuropsychopharmacology, titled “Antiamnesic and Neuroprotective Effects of the Aminotetrahydrofuran Derivative ANAVEX1-41 Against Amyloid-beta (25-35)-Induced Toxicity in Mice,” can be viewed on the publication’s web site at http://www.nature.com/npp/index.html. The authors are Vanessa Villard, Julie Espallergues, Emeline Keller, Tursun Alkam, Atsumi Nitta, Kiyofumi Yamada, Toshitaka Nabeshima, Alexandre Vamvakides and Tangui Maurice.
About Anavex Life Sciences Corp. Anavex Life Sciences Corp. (www.anavex.com) is an emerging biopharmaceutical company engaged in the discovery and development of novel drug targets for the treatment of cancer and neurological diseases such as Alzheimer’s, epilepsy and depression. The company’s proprietary SIGMACEPTOR™ Discovery Platform involves the rational design of drug compounds that fulfill specific criteria based on unmet market needs and new scientific advances. Selected drug candidates demonstrate high, non-exclusive affinity for sigma receptors, which are involved in the modulation of multiple cellular biochemical signaling pathways.
ANAVEX’s SIGMACEPTOR™-N program involves the development of novel and original drug candidates that target neurological and neurodegenerative diseases (Alzheimer’s disease, epilepsy, depression, pain). The company’s lead drug candidates exhibit high, non-exclusive affinity for sigma receptors with strong evidence for anti-amnesic, neuroprotective, anti-apoptotic, anti-oxidative, anti-inflammatory, anti-convulsive, anti-depressant and anxiolytic properties. The company believes that oxidative stress, not amyloid-beta, is the cause of Alzheimer’s. ANAVEX 1-41 and ANAVEX 2-73 modulate sigma receptors, a unique class of receptor molecules, to guard against oxidative stress and repair cells compromised by its effects. So far, through the advanced pre-clinical phase of development, the compounds have performed extremely well in well-recognized animal models of Alzheimer’s disease, underscoring the promise of the company’s new alternative approach to the disease.
ANAVEX SIGMACEPTOR™-C program involves the development of novel and original drug candidates targeting cancer. The company’s lead drug candidates exhibit high, non-exclusive affinity for sigma receptors with strong evidence for selective pro-apoptotic, anti-metastatic and low toxicity properties in various types of solid cancers such as colon, prostate, breast and lung. ANAVEX 7-1037 has already demonstrated its ability to significantly delay the growth of cancerous tumors in patient-derived xenografts during advanced pre-clinical studies.
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 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 file an IND or commence clinical studies. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. 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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