"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(TM)-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 action of ANAVEX 1-41 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(TM)-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.
Published results for ANAVEX 1-41, ANAVEX 2-73 and ANAVEX 7-1037 are available at www.anavex.com/publications.html.
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.
Dr. Kontzalis is a 38-year pharmaceutical-sector veteran. He has held various senior positions at Novartis Pharma in Basel, Switzerland, including Market and Business Analyst for the central nervous system (CNS) portfolio, Group Market and Business Analyst for the transplantation, dermatology, rheumatology and cardiovascular portfolio, and Market Research and Competitive Intelligence Manager for transplantation, immunology and oncology. Dr. Kontzalis was appointed Head of Novartis' Global Market Research Department in 1998, Global Sales Forecasting Manager in 1999, Deputy Head of Global Sales Forecasting in 2003, and was Head of Global Sales Forecasting Operations until 2006.
Dr. Vamvakides has spent 30 years in research, focusing on the therapeutic and pharmacological areas of nootropes, anti-neurodegenerative (anti-Alzheimer's), anti-epileptic, anti-depressive and prototype molecules. The author of more than 80 published scientific papers, he has worked at the Institut National de la Sante et de la Recherche Medicale in Paris, France, University of Athens (Greece), Ciba-Geigy (Basel, Switzerland), Sanofi (Montpellier, France) and many other European research labs for the discovery and development of new concepts in the therapeutic areas of CNS, oncology and anti-inflammatory diseases. Dr. Vamvakides holds a M.Sc. in chemistry from Bordeaux University, France, and a M.Sc. in pharmacology, a M.Sc. in biochemistry and a Ph.D. in molecular pharmacology all from the University of Paris, Medical School.
In December, Dr. Cameron Durrant, a medically trained MBA with an entrepreneurial background and major international pharmaceutical experience, joined the company's Board of Directors. Dr. Durrant is currently Worldwide Vice President of Virology Global Strategic Marketing at Johnson & Johnson. Before joining Johnson & Johnson, Dr. Durrant was President and CEO of PediaMed Pharmaceuticals. Dr. Durrant's background also includes executive-level positions with Merck & Co., GlaxoSmithKline and Pharmacia (now Pfizer). He was a regional winner and national finalist for Ernst & Young's Entrepreneur of the Year award in 2005. Dr. Durrant holds a MBA from Henley Management College at Oxford and a MB and BCh (equivalent to an American MD degree) from the Welsh National School of Medicine in Cardiff, U.K.
Scientific team member Dr. Bourguignon has 30 years experience in medicinal chemistry, including expertise in drug design and optimization as well as organic and physical chemistry. Dr. Bourguignon is a Research Director (CNRS) at the Faculty of Pharmacy, Strasbourg-Illkrich, France.
His background also includes work as a senior scientist at the Center of Neurochemistry (Strasbourg, France), post-doctoral fellow with the department of chemistry at the State University of Buffalo, and as a research associate at the Faculty of Pharmacy in Strasbourg. Dr. Bourguignon holds a Ph.D. in polymer physical chemistry from the Universite Louis-Pasteur in Strasbourg.
The latest addition to the ANAVEX scientific team, Dr. Maurice has 15 years of experience in the field of neurosciences. His expertise is spread across a number of areas, including behavioral and molecular neuropharmacology, sigma receptors, neuropeptides, neurosteroids, neurotrophic factors, normal/pathological aging models for Alzheimer's disease and related disorders, and behavioral phenotyping of rodent models. Before joining ANAVEX, Dr. Maurice held research positions with Institut National de la sante et de la recherche medicale (INSERM) U710 at Montpellier, Centre National de la Recherche Scientifique (CNRS), INSERM U336, the department of neuropsychopharmacology and hospital pharmacy at Meijo University (Nagoya, Japan), and Jouveinal Research Institute (Fresnes, France). A past recipient of the CNRS bronze medal, Dr. Maurice holds a Ph.D. in cellular and molecular biology with a specialty in neuropharmacology from Universite Montpellier.
"ANAVEX's work is led by a strong, proven management team and Board ofDirectors supported by a highly skilled scientific team of biochemists, molecular pharmacologists and biologists, working in collaboration with leading academic institutions," said Dr. Kontzalis. "With seven lead candidates and an additional 50 compounds at various early stages of discovery, ANAVEX has one of the industry's most robust pipelines of disease-modifying drugs. We plan to continue to focus on best-in-class products that take radically different approaches to drugs on the market today which, in many cases, treat symptoms instead of the underlying causes of a particular disease. Our team looks forward to a highly successful 2008."
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. The company's proprietary SIGMACEPTOR(TM) Discovery Platform involves the rational drug design of 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(TM)-N program involves the development of noveland 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-oxidative, anti-inflammatory, anti-convulsive, anti-depressant and anxiolytic properties.
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 such as colon, prostate, breast, lung, etc.
For further information, please visit http://www.anavex.com.