Athens, Greece — December 4, 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, was selected to present its latest results with ANAVEX 1-41 at Neuroscience 2008, the 38th annual meeting of the Society for Neuroscience, which took place November 15-19, 2008 in Washington, DC.
In a scientific poster abstract, ANAVEX detailed the outstanding neuroprotective potential of ANAVEX 1-41, evidenced by its ability to block the manifestation of the earliest toxic effects in a validated mouse model of Alzheimer’s disease. Currently in the late pre-clinical stage, ANAVEX 1-41 has shown synergistic potential for anti-amnesic and neuroprotective efficacy at extremely low doses. This is the first time these results have been attained by any pharmacological agent in an Alzheimer’s mouse model involving the injection of the amyloid-beta (25-35) peptide.
“We are excited by our ongoing progress in the development of ANAVEX 1-41 as it continues to demonstrate powerful neuroprotective action at extremely low doses with no toxicity,” said Dr. Vamvakides, Chief Scientific Officer of ANAVEX. “In addition, we believe that our latest findings have relevance for ANAVEX 2-73, another lead Alzheimer’s compound, as 1-41 and 2-73 have a common origin and similarities in mechanism of action.”
The earliest toxic effects of Alzheimer’s disease mouse models were measured by the expression of the caspase-12 marker. Caspase 12 is a recently discovered enzyme that indicates these early toxic effects. Non-transgenic Alzheimer’s mouse models are created by injecting amyloid-beta peptide (Αβ25-35) into mouse brains to bring on histological and biochemical changes, oxidative stress and learning deficits.
The neuroprotective potential of ANAVEX 1-41 is hypothesized to act by the compound’s ability to modulate sigma receptors which regulate calcium mobilization in neuronal cells. Calcium is regulated through the Inositol Triphosphate receptors “IP3R” and the sarcoendoplasmic reticulum “Ca2+/ATPase” pump.The major effect of ANAVEX 1-41 occurs at the membrane of neuronal cells, in the endoplasmic reticulum (ER). The novel profile of ANAVEX 1-41, which is a mixed sigma-1, muscarinic and sodium-channel candidate drug, accounts for its ability to fight ER stress and thereby prevent apoptosis of the neuronal cells. This neuronal apoptosis is the prominent pathophysiological effect of brain degeneration in Alzheimer’s disease.
The neuroprotective effects of ANAVEX 1-41 were assessed in the hippocampus, the area of the brain that regulates learning, emotion and memory and which is highly implicated in Alzheimer’s disease. As recently discovered in pre-clinical testing, through its sigma-1 activity, ANAVEX 1-41 targets neuron structures (ER, mitochondria), as well as disturbed biochemical pathways and channels (UPR,IP3R,Bcl-2,apoptosis). Organizations involved in sigma receptor research, including ANAVEX, have determined that these are crucial factors in Alzheimer’s disease and in many other neurodegenerative diseases.
The company expects to complete pre-clinical trials on ANAVEX 1-41 in early 2009.
ANAVEX 1-41 and ANAVEX 2-73 share a common origin and related profile (congeners). ANAVEX is currently planning to prepare the Investigational New Drug (IND) (or IMPD) file to advance 2-73 to Phase 1 human clinical trials, which are expected to begin in 2009.
A copy of the poster abstract, titled “The neuroprotective action of ligands acting at the sigma-1 chaperone protein involves regulation of the expression of IP3 receptor subtypes and SerCa pumps,” can be viewed on the company’s web site at www.anavex.com. The authors are Vanessa Villard, Fanny Malhaire-Ferreux, François Monnet, 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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