Anavex Screening Healthy Volunteers for Phase I, First-in-Human Clinical Study in Alzheimer’s disease
Hoboken, NJ — March 31, 2011 — Anavex Life Sciences Corp. (“Anavex”) (OTCBB: AVXL) today announced screening of the first healthy volunteers for the Phase I clinical study of ANAVEX 2-73, its lead compound for the treatment of Alzheimer’s disease. ANAVEX 2-73 is the first of a new class of wholly-owned, oral, disease-modifying compounds, which act through sigma-1 receptor agonism as well as muscarinic cholinergic effects and up-regulation of Bcl-2. ANAVEX 2-73 also modulates endoplasmic reticulum stress and triggers a series of intracellular effects thought to modify ion channel signalling at the mitochondrial level. In pre-clinical studies, ANAVEX 2-73 and its only and active metabolite, ANAVEX 19-144, alleviated neurotoxicity and cognition deficits associated with Alzheimer’s disease in animals. Toxicity studies in mice, rats and dogs showed a favorable safety profile.
The Phase I trial, in at least 16 healthy volunteers, is a randomized, placebo-controlled, dose-escalating study designed to assess the safety, tolerability and pharmacokinetics of oral ANAVEX 2-73 and will help determine the maximally tolerated dose in humans. The study is being carried out in collaboration with ABX-CRO, which has conducted various Alzheimer’s disease studies, and the University of Dresden in Germany.
“We are excited that the first human study for ANAVEX 2-73 is underway. ANAVEX 2-73 has been more than a decade in the making, so this event marks a great milestone for our company,” said Dr. Cameron Durrant, Executive Chairman of Anavex.
About Alzheimer’s Disease
While Alzheimer’s disease is most common in people over the age of 65, it can strike adults of any age irrespective of their gender, background or socioeconomic status. According to the Alzheimer’s Association, an estimated 5.4 million Americans are currently living with Alzheimer’s disease. The number of Americans aged 65 and over with Alzheimer’s is estimated to reach 7.7 million in 2030. This represents a 50 percent increase from the 5.2 million Americans aged 65 and older who are currently affected. The Alzheimer’s Association further projects that the number of Americans aged 65 and older who are affected by Alzheimer’s disease may triple to between 11 and 16 million by 2050 unless there are developments to prevent or more effectively treat the disease.
About ANAVEX 2-73
ANAVEX 2-73 is the first of a new class of oral, disease-modifying drugs being studied to potentially treat Alzheimer’s disease itself, versus treating its symptoms.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (www.anavex.com) is a specialty pharmaceutical company engaged in the discovery and development of novel drug candidates for the treatment of neurological diseases and cancer. The Anavex proprietary SIGMACEPTOR™ Discovery Platform involves the rational design of drug compounds targeted to specific receptors involved in the modulation of multiple cellular biochemical signaling pathways.
The SIGMACEPTOR™-N program involves the development of novel drug candidates that target neurological and neurodegenerative diseases (Alzheimer’s disease, epilepsy, depression, pain). The company’s lead drug candidates exhibit high affinity for sigma receptors, which have been extensively documented as potentially valuable drug targets and have demonstrated anti-amnesic and neuroprotective properties. A portfolio of back-up compounds to ANAVEX 2-73 are also in development.
Anavex is a publicly traded company under the symbol 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. Forward-looking statements in this press release include that our lead drug candidate has potentially valuable anti-amnesic and neuroprotective properties, may help with cognition deficits and that ANAVEX 2-73 is the first of a new class of oral, disease-modifying drugs which could potentially treat Alzheimer’s disease. 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 retain key employees and our ability to finance development or satisfy the rigorous regulatory requirements for new drugs. Competitors may develop better or cheaper alternatives to our products. 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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