Findings Correlate with Positive Phase 1 Safety Data for ANAVEX 2-73
New York, NY — March 4, 2014 — Anavex Life Sciences Corp. (“Anavex” or the “Company”) (OTCQB: AVXL) is encouraged by the findings of a research report published in the current issue of peer-reviewed scientific journal Life Sciences. Among its conclusions, the report reveals that sigma-1 receptor (S1R) agonists play an important role in the prevention, delay or reduction of heart disease. These findings correlate with the positive electrocardiogram (EKG) parameters in the successfully completed human clinical Phase 1 safety trial of ANAVEX 2-73, an orally available S1R agonist drug candidate developed to treat Alzheimer’s through potential disease modification. ANAVEX 2-73 has also shown highly encouraging synergy with donepezil, the world’s best-selling Alzheimer’s drug, and a Phase 1b/2a clinical trial of this combination, ANAVEX PLUS, is planned for the first half of 2014.
“The findings from this new study are thought to be exceptionally important because the advanced age of Alzheimer’s patients makes them more susceptible to heart disease,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “For this reason, the cardioprotective effect displayed by sigma-1 receptor agonists could positively impact the safety of Alzheimer’s drug candidates like ANAVEX 2-73, which target the sigma-1 receptor. The findings in this report also provide further evidence of the beneficial effect of sigma-1 receptor agonists on neuroprotection and cell preservation.”
It is possible that ANAVEX 2-73 will have a similar beneficial effect on heart cell mitochondria as it recently demonstrated the ability to repair mitochondrial functionality in the hippocampus, the part of the brain involved with learning, memory and emotions. Mitochondrial dysfunction has been consistently reported as an early cause of Alzheimer’s disease.
Research Report Findings
The Life Sciences report describes the significant correlation between reduced S1R expression in the heart and impaired cardiac function. It concludes that S1R stimulation by agonists pharmacologically promotes anti-hypertrophic (reduction in abnormal organ or tissue enlargement) and cardioprotective action through mitochondrial calcium transport and ATP production. Hypertrophy can ultimately progress to ventricular dilatation, contractile dysfunction and heart failure.
The mitochondria of the cardiac muscle, which is essential for ATP generation, produces the energy used to maintain cardiac muscle contractile function. As such, mitochondrial dysfunction promotes development of heart failure.
According to the study, fluvoxamine and other S1R agonists directly stimulate the S1R in heart muscle (cardiomyocyte), thereby rescuing the cardiac dysfunction. The report also suggests that stimulation of both heart and brain S1R plays an important role in the protection from heart disease.
The report, entitled “Fluvoxamine rescues mitochondrial Ca2+ transport and ATP production through sigma 1-receptor in hypertrophic cardiomyocytes,” was authored by Dr. Kohji Fukunaga and colleagues from the Department of Pharmacology, Tohoku University, Sendai, Japan and the Division of Molecular Cardiovascular Biology, Department of Pediatrics, Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (www.anavex.com) is a clinical stage biopharmaceutical company engaged in the development of novel drug candidates to treat Alzheimer’s, CNS diseases and various types of cancer. ANAVEX 2-73, an orally available drug candidate developed to treat Alzheimer’s through potential disease modification, has undergone an initial Phase 1 human clinical trial and was well tolerated in doses up to 55mg. Results from pre-clinical studies indicate that ANAVEX 2-73 demonstrates anti-amnesic and neuroprotective properties. A highly encouraging synergistic effect has also been observed between ANAVEX 2-73 and Aricept® (donepezil). The combined therapeutics ANAVEX PLUS produced up to 80% greater reversal of memory loss in Alzheimer’s disease models versus when the drugs were used individually. 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 set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. 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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