"This past year has been extremely successful for ANAVEX, with important achievements in all business areas. As a result, we are well positioned for excellent progress in 2008 and beyond," said Dr. Kontzalis, Chief Executive Officer for ANAVEX. "This year ANAVEX is planning to file Investigational New Drug (IND) applications for three lead drug candidates, commence Phase 1 clinical trials of our lead Alzheimer's compound, explore stock exchange opportunities in the United States, and expand our scientific collaborations beyond the European community to include American research and academic institutions. In addition, we are proceeding with an accelerated pre-clinical development program to advance several additional compounds that are in the discovery or lead optimization stage."
Pre-clinical studies for three of ANAVEX's lead drug candidates are nearing completion, including those for Alzheimer's, epilepsy and colorectal cancer. At the same time, other compounds targeting depression and other forms of cancer (prostate, breast, lung) are being quickly advanced through the pre-clinical stages.
In 2008, once pre-clinical studies have been completed, ANAVEX plans to submit IND applications for three compounds so that we can commence Phase 1 clinical trials. We expect to submit IND filings for ANAVEX 1-41 (Alzheimer's) in April 2008, followed by an application for ANAVEX 2-73 (epilepsy) in August 2008, and ANAVEX 7-1037 (colorectal cancer and other solid tumors) by December 2008. ANAVEX 1-41 is expected to be the first compound to reach Phase 1 clinical trials, with human testing expected to commence in late 2008 or early 2009.
Also in 2008, ANAVEX plans to strategically explore marketplace choices and opportunities in the United States. The company believes that the benefits of listing on a senior stock exchange would include expanded relationships with the American investment community and the support of a larger, more liquid trading market.
ANAVEX is aiming to sign licensing agreements for its lead CNS candidates following Phase 1 clinical trials. The company is motivated to pursue licensing agreements for its oncology drug candidates at an earlier stage.
World-Class Strategic Partnerships
ANAVEX has forged strong scientific collaborations with leading European research and academic institutions, including Universite Montpellier, Universite Louis-Pasteur, EuroGENET Laboratories and the Academy of Athens' Institute of Biomedical Research. With these partnerships, ANAVEX is able to outsource parts of the R&D process to drive capital efficiency while maintaining intellectual property and research control. In 2008, ANAVEX plans to expand its scientific collaborations to include major U.S. research and academic institutions.
ANAVEX's SIGMACEPTOR™ -N program pipeline is focused on developing disease-modifying treatments for neurological conditions.
Considerable advancements have been made with ANAVEX 1-41. In recent pre-clinical animal studies, the compound demonstrated significant neuroprotective benefits through the prevention of oxidative stress, which damages and destroys cells and is believed to be a primary cause of Alzheimer's disease. The novel mechanism of its action demonstrates that the compound may influence the course of Alzheimer's disease and prevent or limit the creation of plaques that destroy brain cells in the hippocampus, the part of the brain that regulates learning, emotion and memory. Published results were presented at the Neuroscience 2007 conference in San Diego, California. Testing on ANAVEX 1-41 is being conducted in cooperation with Universite Montpellier in France. Phase 1 trials of ANAVEX 1-41 on humans are scheduled to commence in late 2008 or early 2009.
The company has also made promising developments with ANAVEX 2-73, its lead drug candidate to treat epilepsy. Results from epilepsy animal models reveal that both compounds have significant anticonvulsant, anti-amnesic and neuroprotective properties. These activities involve muscarinic and sigma-1 receptor components, which is significant because it indicates a unique mode of action that may help control epilepsy and prevent the process that causes long-term damage to tissue and cells as well as biochemical and physiological alterations to the brain. Published results were presented at the Neuroscience 2007 conference in San Diego. Ongoing pre-clinical studies are being conducted in collaboration with Universite Montpellier and are scheduled for completion by the end of May 2008.
ANAVEX's SIGMACEPTOR™ -C program pipeline involves the development of novel and original drug candidates targeting cancer.
ANAVEX 7-1037, the company's lead drug candidate for the treatment of colorectal cancer and other types of solid tumors, recently revealed chemotherapeutic potential without toxic side effects in advanced pre-clinical studies. The compound has been shown to kill human colon cancer cells and also significantly suppress tumor growth in immune-deficient mice. Published results were presented at the 15th Euroconference on Apoptosis in Portoroz, Slovenia. Testing on ANAVEX 7-1037 is being conducted in cooperation with the Academy of Athens' Institute of Biomedical Research.
On the corporate front in 2007, Dr. Panos Kontzalis was appointed as Chief Executive Officer and Director, Dr. Alexandre Vamvakides became Chief Scientific Officer and Director, and ANAVEX added a distinguished, medically trained MBA to its Board of Directors. The company also attracted prominent scientists Dr. Jean Jacques Bourguignon and Dr. Tangui Nicolas Maurice, who joined the company's scientific team and were appointed as members of the scientific committee.
Anavex Life Sciences Corp. (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.
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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.