Anavex Invited to File Funding Application for Phase 2a Clinical Trial of ANAVEX 2-73
VANCOUVER, BC – May 6, 2013
Anavex Life Sciences Corp. (“Anavex”) (OTCQB: AVXL) ) today announced that it has been invited to submit a full grant application to the Alzheimer’s Drug Discovery Foundation (“ADDF”) for a Phase 2a trial of ANAVEX 2-73. Since 1998, the ADDF has granted more than $51 million in venture philanthropy funding to projects with potential viability in the market. Subsequent to the ADDF’s initial funding, grantees have received commitments of over $2 billion in follow-on funding from government, pharmaceutical companies and venture capital firms to further advance their drugs. “We are excited by this invitation to submit a funding application for a Phase 2a trial of ANAVEX 2-73,” said Tom Skarpelos, director of Anavex. “The data generated for ANAVEX 2-73 to date indicates that it has the potential to prevent, halt and/or reverse the course of Alzheimer’s disease, which could improve the lives of millions of Americans.”
In pre-clinical studies, ANAVEX2-73 demonstrated cognitive benefit, the ability to protect neurons to prevent cell death, and a clear synergic effect with Aricept® (donepezil HCl), a leading, FDA-approved Alzheimer’s treatment. A Phase 1 human clinical trial of ANAVEX 2-73 has also been successfully completed.
The objective of the proposed Phase 2a clinical trial is to demonstrate objective biomarker data that can be correlated to clinical findings. It would also seek to confirm the pre-clinical synergy observed when combining ANAVEX 2-73 with donepezil in patients with Alzheimer’s disease. Data generated would help determine the decision to proceed to a larger Phase 2 trial.
The invitation to submit a full application was received following the filing by Anavex of a Letter of Intent for a grant titled, “Clinical phase 2a study of ANAVEX 2-73 in patients using FDG-PET imaging as a functional biomarker.” Anavex now intends to file a full application with the ADDF. There can be no assurance that the Company’s application for a grant from the ADDF will be approved.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (www.anavex.com) is a pharmaceutical company engaged in the development of novel drug candidates. ANAVEX 2-73, a drug candidate developed to treat Alzheimer’s disease through disease modification, has undergone an initial Phase 1 human clinical trial and was well tolerated in doses up to 55mg. Sponsored pre-clinical studies indicate that ANAVEX 2-73 demonstrates anti-amnesic and neuroprotective properties. Anavex is a publicly traded corporation quoted as AVXL.
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 pass clinical trials so as to move on to the next phase, our ability to finance development or satisfy the rigorous regulatory requirements for new drugs, our ability to attract and retain quality personnel, and that despite positive results, our competitors may offer better or cheaper alternatives. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. 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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