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Anavex completes successful preclinical studies on lead Alzheimer's drug candidate

Tuesday September 2, 9:00 am ET

ATHENS, GREECE, Sept. 2 /PRNewswire-FirstCall/ - 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, today announced the successful completion of preclinical studies (in-vitro and in-vivo in mice) on ANAVEX 2-73, a novel sigma-1 receptor agonist for the treatment of Alzheimer's disease. This success enables ANAVEX to start preparing the Investigational New Drug (IND) (or IMPD) file to move to Phase 1 human clinical trials.

"The completion of preclinical studies is a key milestone for our company, and means that we are now ready to prepare our first IND for Alzheimer's disease and move towards human trials," said Harvey Lalach, President of ANAVEX. "Our novel approach is based on ANAVEX's expertise and leadership in the field of sigma receptors and our highly productive drug discovery platform. This approach has made it possible for us to develop the first in a series of novel, new-generation drugs using sigma ligands to treat a range of CNS and oncological conditions. We are excited to be advancing this first novel compound for Alzheimer's disease toward clinical trials."

In preparation for an IND/IMPD filing, ANAVEX is engaging an expert Contract Research Organization (CRO) to perform final toxicity, pharmacokinetic, pharmacodynamic and metabolism studies in various animal species. Thereafter the IND (or IMPD) file will be submitted to the FDA (or the EMEA respectively) for approval in order to start Phase 1 clinical trials targeted for the first half of 2009.

ANAVEX 2-73 is a novel tetrahydrofuran that exhibits high affinity and selectivity to sigma-1 receptors and synergistic action with muscarinic receptors. Additional beneficial effects have been demonstrated on NMDA receptors. During preclinical studies (in-vitro and in-vivo in mice), ANAVEX 2-73 demonstrated significant neuroprotective, anti-amnesic and anti-convulsive properties. It also exhibited an excellent safety profile and therapeutic activity at very low doses.

ANAVEX 2-73 has been shown to provide protection from oxidative stress, which damages and destroys neurons and is believed to be a primary cause of Alzheimer's disease. Research in recent years indicates that oxidative stress is a precursor to amyloid-beta plaques and tau (Neuro-Fibrillary Tangles or NFT) and, as such, is the appropriate therapeutic target. ANAVEX 2-73 is not focused on reducing or dissolving amyloid-beta protein, unlike drug candidates from other biopharmaceutical companies that have recently produced disappointing clinical results.

Preclinical studies on ANAVEX 1-41, another lead compound targeting Alzheimer's disease and depression, are scheduled for completion in Q4 2008.

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, uses 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 compound has performed extremely well in well-recognized animal models of Alzheimer's disease, underscoring the promise of this 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.