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ANAVEX outlines corporate milestones, drug advancement plans for 2008
GENEVA, SWITZERLAND, Jan. 22 - Anavex Life Sciences Corp. ("ANAVEX") (OTCBB:
AVXL) reported today that the company achieved significant development of its lead
drug candidates and in the growth of its management and scientific teams during
2007. The company further disclosed key corporate objectives for 2008.
"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."
2008 OBJECTIVES
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.
Pipeline Highlights
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 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™-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.
Corporate Developments
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 (NYSE: JNJ - News). 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 of Directors
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'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-oxidative, 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 colon, prostate, breast, lung, etc.
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