Anavex comments on failure of Pfizer and Medivation's Alzheimer's investigational drug Dimebon during Phase 3 clinical trials

GENEVA, SWITZERLAND, March 3 /PRNewswire-FirstCall/ -- Anavex Life Sciences Corp. ("ANAVEX") (OTCBB: AVXL) today issued a statement following today's announcement from Pfizer and Medivation (NASDAQ:MDVN) that their investigational Alzheimer's drug Dimebon did not meet either its co-primary or secondary endpoints compared to placebo during pivotal Phase 3 clinical trials.
 

"While this is disappointing for the Alzheimer's community, there have been many doubts expressed about Dimebon. These doubts have been documented by leading scientists, including ex-National Institutes of Health (NIH) staffers. This failure of Dimebon, which was hypothesized to act as a mitochondrial pore blocker, on top of the repeated failures of every drug studied for removing beta amyloid from the brain as a way to manage Alzheimer's disease, suggests that novel mechanisms of action that attempt to modify the disease itself, rather than treat symptoms, are necessary," said Cameron Durrant, MD, MBA, Executive Chairman of the ANAVEX Board of Directors.
 

ANAVEX is preparing to enter Phase 1 clinical trials with ANAVEX 2-73, its lead compound for the treatment of Alzheimer's disease, later this year.
 

ANAVEX 2-73 is a first of a new class of oral, disease-modifying drugs for the treatment of Alzheimer's disease, which employ an approach that targets neither amyloid, nor tau, nor mitochondrial pore blockade.
 

About Anavex Life Sciences Corp.
 

Anavex Life Sciences Corp. (www.anavex.com) is a publicly traded biopharmaceutical company engaged in the discovery and development of novel drug candidates for the treatment of cancer and neurological diseases such as Alzheimer's, epilepsy, depression and pain. The company's proprietary SIGMACEPTOR(TM) Discovery Platform involves the rational design of drug compounds that fulfill specific criteria and are targeted to specific receptors involved in the modulation of multiple cellular biochemical signaling pathways.
 

ANAVEX's SIGMACEPTOR(TM)-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, which have been extensively documented as potentially valuable drug targets and have demonstrated evidence for anti-amnesic and neuroprotective properties. The company is developing non-amyloid focused approaches to disease modification in Alzheimer's disease. ANAVEX 1-41 and ANAVEX 2-73 modulate sigma receptors, a unique class of receptor molecules, to guard against oxidative stress and work through alternative mitochondrial pathways via ion channel signalling. So far 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's SIGMACEPTOR(TM)-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. 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. Forward-looking statements in this press release include that our drug compounds show promise to combat certain diseases. 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.
 

Source: Anavex Life Sciences Corp.

CONTACT: Anavex Life Sciences Corp., Research & Business Development,
Email: info@anavex.com; Shareholder & Media Relations, Toll-free:
1-866-505-2895, Outside North America: (416) 489-0092, Email: ir@anavex.com,
www.anavex.com
 

Posted: March 2010

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