Geneva, Switzerland — September 30, 2009
Anavex Life Sciences Corp. (“ANAVEX” or the “Company”) (OTCBB: AVXL) has selected FORENAP Pharma EURL (“FORENAP”) as the contract research organization (CRO) for Phase I clinical trials of ANAVEX 2-73, the company’s lead Alzheimer’s drug candidate. FORENAP has been involved in pre-clinical and clinical research for 20 years and is renowned for its expertise in Central Nervous System (CNS) studies, including Alzheimer’s disease.
“The selection of a world-class CRO is an important milestone in our product development process and it underscores our commitment to advance ANAVEX 2-73 through Phase I clinical trials,” said Dr. Hervé de Kergrohen, CEO of ANAVEX. “We are moving forward into these trials based on the positive results of our pre-clinical testing, which demonstrated the compound’s significant disease-modifying potential and its powerful anti-amnesic and neuroprotective properties.”
FORENAP Pharma will perform study setup, protocol review, site monitoring, and project management for the trials. All work will be performed under individual work orders that fall under a master services agreement executed by FORENAP and ANAVEX including pre-clinical, pharmaceutical and clinical development of ANAVEX 2-73.
“We are pleased to be partnering with ANAVEX for clinical trials of its Alzheimer’s disease lead drug candidate,” said Dr. Remy Luthringer, CEO of FORENAP Pharma. “There is a critical need for drugs that can modify the course of devastating CNS disorders such as Alzheimer’s disease. We look forward to running a high-quality and cost-effective program as ANAVEX works to confirm its pre-clinical findings in a clinical setting.”
ANAVEX 2-73, a sigma-1 receptor agonist, has been shown in pre-clinical testing to be neuroprotective and anti-amnesic. It is postulated that ANAVEX 2-73 impacts mitochondrial dysfunction, which is thought by many researchers to be one of the hallmarks of Alzheimer’s disease, and may be mitochondrial protective. This innovative approach focuses on addressing an underlying cause of Alzheimer’s disease, unlike current drugs on the market that provide only symptomatic relief. Based on recent data, sigma receptors are implicated in oxidative stress, through modulation of calcium signaling via the mitochondria.
About Anavex Life Sciences Corp. Anavex Life Sciences Corp. (www.anavex.com) is a global company with headquarters inSwitzerland. The company is engaged in the discovery and development of novel drug targets for the treatment of neurological diseases and cancer. ANAVEX’s proprietary SIGMACEPTOR™ Discovery Platform involves the rational design of drug compounds that fulfill specific criteria based on unmet medical and market needs and new scientific advances.
ANAVEX’s SIGMACEPTOR™-N program involves the development of novel drugs that target neurological and neurodegenerative diseases, such as Alzheimer’s disease, epilepsy, depression, pain and neuropathic pain. The company’s lead candidates have shown strong evidence for anti-amnesic and neuroprotective properties in studies conducted to date. ANAVEX believes that mitochondrial dysfunction can be modulated via sigma receptors, a unique class of receptor molecules, to guard against oxidative stress.
ANAVEX’s SIGMACEPTOR™-C program involves the development of novel drugs targeting cancer. The company’s lead candidates have shown strong evidence for selective pro-apoptotic, anti-metastatic and low toxicity properties in various types of solid cancers. 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.
About FORENAP Pharma FORENAP Pharma (www.forenap.com) is an international Contract Research Organisation (CRO) and Site Management Organisation (SMO) specialised in early drug development and research in Neurosciences. Since 1986, FORENAP has been active in the pre-clinical and clinical development of new pharmaceutical compounds providing full range of in-services. FORENAP’ structure and network enable to carry out a “full service package” (from pre-clinical to Phase IV) and offer consultancy services from drug discovery to marketing authorisation. Phase I studies in all therapeutic areas are performed in a 72 highly monitored bed equipped centre, which is specifically dedicated to CRO activities. Moreover, FORENAP owns a unique Technological platform combined with in-house technological expertise for investigating CNS active compounds. Part of FORENAP’s know-how is to achieve proof-of-concept studies, i.e. in parallel to safety and PK measurements, to evidence pharmacodynamic effects as soon as pre-clinical and early clinical development. In addition, FORENAP carries out Phase II/III and IV studies mainly in patient suffering from depression, anxiety, sleep disorders, schizophrenia, epilepsy or Alzheimer’s disease.
Forward-Looking Statements 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.
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