Anavex Comments on FDA Plan to Expedite Approval of New Alzheimer’s Drugs
VANCOUVER, BC – March 13, 2013
Anavex Life Sciences Corp. (“Anavex”) (OTCQB: AVXL) today commented on the United States Food and Drug Administration’s (FDA) plan to expedite the approval of new treatments for Alzheimer’s disease. As reported by the New York Times, drugs in clinical trials would qualify for approval if people with very early-stage Alzheimer’s showed even subtle improvement in memory or reasoning tests. ANAVEX 2-73, the company’s lead compound for Alzheimer’s disease, has successfully completed a Phase 1 clinical trial in humans.
“Anavex strongly supports this proposal to accelerate the approval of drugs that could slow down or prevent Alzheimer’s disease,” said Tom Skarpelos, director of Anavex. “This FDA proposal has the potential to help tens of millions of Americans, including those at risk of developing the devastating disease and those in the early stages, when disease-modifying medications would be extremely useful.”
Data from the ANAVEX 2-73 Phase 1 human clinical trial indicates that the drug is well tolerated with no dose-limiting toxicities unrelated to the drug’s mechanism of action. World-renowned Alzheimer’s scientists have published studies showing that ANAVEX 2-73 protects neurons to prevent cell death and reverses symptoms of the disease in mouse models. Pre-clinical animal studies showed early signs of efficacy, improvement in the memory of animals and, in some cases, a disease-modifying effect.
The FDA has approved only five drugs for the treatment of Alzheimer’s disease. Each of these drugs is symptomatic, meaning they treat symptoms, rather than the disease itself. They do not have the ability to stop the onset or progression of Alzheimer’s disease.
ANAVEX 2-73 was developed to treat Alzheimer’s through a mechanism of action that modifies the disease, rather than temporarily addressing symptoms of the disease.
“We are excited by the potential of ANAVEX 2-73 to help conquer Alzheimer’s disease,” added Mr. Skarpelos. “The data generated to date supports our approach to potentially prevent, halt and/or reverse the course of Alzheimer’s disease.”
The FDA proposal was published in the New England Journal of Medicine on March 13, 2013.
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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