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Anavex advances drug candidate for treatment of Alzheimer's disease

Results from animal model testing demonstrate ANAVEX 1-41 has significant neuroprotective and anti-amnesic benefits

GENEVA, Nov. 28 /PRNewswire-FirstCall/ - Anavex Life Sciences Corp. ("ANAVEX") (OTCBB: AVXL) is pleased to announce promising developments with ANAVEX 1-41, the company's lead drug candidate for Alzheimer's disease. In recent pre-clinical animal studies, ANAVEX 1-41 prevented oxidative stress, which damages and destroys cells and is believed to be a primary cause of Alzheimer's disease. ANAVEX 1-41 also prevented the expression of caspase-3, an enzyme that plays a key role in programmed cell death and in the loss of cells in the hippocampus, the part of the brain that regulates learning, emotion and memory.

The results are further highlighted in that this activity involves both muscarinic and sigma-1 receptor systems indicating a novel mechanism of action. Published results were presented at the Neuroscience 2007 conference in San Diego, California, and are available at http://www.anavex.com/publications.html. Testing on ANAVEX 1-41 is being conducted in cooperation with Universite Montpellier in France.

"The fact that we have evidence of neuroprotective action, which is essentially protection to any part of the body's nervous system, through the prevention of oxidative stress is a major milestone in the development of ANAVEX 1-41," said Dr. Vamvakides, Chief Scientific Officer of ANAVEX. "With this novel mechanism of action we anticipate that ANAVEX 1-41 may slow the progression of Alzheimer's disease and considerably improve the quality of life of those impacted by the disease as well as their caregivers."

The pre-clinical studies tested ANAVEX 1-41's ability to protect neurons, the nerve cells that make up the central nervous system, from degeneration or death. Testing was conducted in a non-transgenic mouse model of Alzheimer's disease. The brains of mice were injected with amyloid beta peptide, the key ingredient in Alzheimer's brain plaques, which is known to induce histological and biochemical changes, oxidative stress and learning deficits within seven days.

When ANAVEX 1-41 was administered to mice during pre-clinical testing, the compound dose prevented amyloid-beta-induced learning in the spontaneous alternation and passive avoidance performances. In addition, it blocked the induction of amyloid-beta-induced lipid peroxidation, the biochemical process that mediates damage to nerve cell membranes. ANAVEX 1-41 also reduced the loss of pyramidal cells in the hippocampus and blocked the amyloid-beta-induced expression of caspase-3.

ANAVEX 1-41 has been previously shown to reverse learning deficits in mice that were induced by the drugs scopolamine and dizocilpine, or through the administration of amyloid beta peptide. In addition to these findings, the ANAVEX scientific team recently reported the neuroprotective potential of sigma-1 receptor drugs due to their sigma-1 receptor modulatory role on calcium mobilization and signal transduction pathways.

"We are excited by the data that was presented at the Neuroscience 2007 conference regarding the neuroprotective and anti-amnesic properties of ANAVEX 1-41 for Alzheimer's disease," said Dr. Kontzalis, Chief Executive Officer for ANAVEX. "We are committed to further exploring the disease-modifying properties of ANAVEX 1-41 and to meeting our ultimate goal of developing novel therapies to prevent the onset of or slow the progression of Alzheimer's disease."

ANAVEX 1-41 pre-clinical studies will be completed in the coming weeks. Once pre-clinical testing is complete, ANAVEX will commence with IND filing so that human trials of ANAVEX 1-41 can begin.

About Alzheimer's disease

Alzheimer's disease is the most common cause of dementia and is characterized by the progressive degeneration of cognition as a result of the destruction of nerve cells in the brain. Dementia affects an estimated 37 million people worldwide and approximately 50% of these cases are caused by Alzheimer's disease. In March 2007, the Alzheimer's Association reported that 5.1 million people in the United States (4.9 million of whom are aged 65 and older) are living with Alzheimer's disease. This represents an increase of at least 10% from the previous prevalence estimate of 4.5 million. By 2015, there could be as many as 16.8 million people with Alzheimer's disease in the major seven pharmaceutical markets unless novel drug treatment therapies are discovered.

Medications currently available to treat Alzheimer's disease include acetylcholinesterase inhibitors and N-methyl-D aspartate receptor antagonists. Both types of medications only treat symptoms of the disease - they do not stop the onset and progression of Alzheimer's disease.

In conclusion, there are very real and unmet medical requirements for drug therapies to treat Alzheimer's disease. The impressive market size leaves no doubt for the business opportunity presented by treatments for Alzheimer's disease.

Drugs able to act on the underlying disease pathology and modify disease onset and progression, demonstrating neuroprotective, anti-amnesic and preventive properties combined with excellent safety and low toxicity, have the potential for blockbuster sales.

About Sigma Receptors

Sigma receptors are a unique family of proteins, present mainly in the Central Nervous System (CNS) but also in various peripheral tissues. The receptors are classified in two subtypes: the sigma-1 and sigma-2. These subtypes are distinguishable pharmacologically, functionally and by molecular size. Sigma-1 receptors have been cloned and shown to be distinct from any known receptor class.

In the CNS, they are involved in the modulation of neurotransmitter receptor function, neurotransmitter release and response, as well as memory and learning processes, demonstrating potential neuroprotective and anti-amnesic properties. The modulatory action and the implication of numerous cellular and biochemical signaling pathways suggest possible sigma receptor involvement in many neuronal processes, as well as in the pathophysiology of certain psychiatric disorders including depression, schizophrenia, motor disturbances, neuropathic pain, drug addiction, and attention deficit disorders.

ANAVEX's SIGMACEPTOR™-N program involves the development of novel and original drug candidates, targeting neurological and neurodegenerative diseases (Alzheimer's disease, epilepsy, depression, etc.). The company's lead drug candidates exhibit high, non-exclusive affinity for sigma receptors with strong evidence for anti-amnesic, neuroprotective, anti-apoptotic, anti-oxidatitive, anti-inflammatory, anti-convulsive, anti-depressant, and anxiolytic properties.

ANAVEX's 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 cancer of the colon, prostate, breast, lung, etc.