Anavex Reports Predicted Clinical Effect of Both ANAVEX 2-73 and ANAVEX PLUS in a Humanized Cortical Cognitive Model for Alzheimer’s Disease
NEW YORK – March 27, 2014
Anavex Life Sciences Corp. (“Anavex” or the “Company”) (OTCQB: AVXL), a clinical stage biopharmaceutical company developing novel drug candidates to treat Alzheimer’s, diseases of the central nervous system (CNS) and various types of cancer, today announced that a report in the current issue of peer-reviewed International Pharmaceutical Industry Journal (“IPI Journal”) predicts that ANAVEX 2-73 will have a meaningful effect in Alzheimer’s disease based on the Alzheimer’s Disease Assessment Scale-Cognitive (“ADAS-Cog”), especially when combined with donepezil (Aricept®), the world’s best-selling Alzheimer’s drug. The Company believes this drug combination, called ANAVEX PLUS, is a compelling commercial opportunity because of its potential to treat symptoms of Alzheimer’s while also possibly modifying or reversing the course of the disease. A Phase 1b/2a clinical trial of ANAVEX PLUS, is scheduled to begin mid 2014.
The findings, utilizing a predictive humanized calibrated cortical cognitive model for Alzheimer’s Disease in, which was focusing on symptomatic effects based on the M2 antagonistic target engagement level of ANAVEX 2-73, predict that ANAVEX PLUS, combining ANAVEX 2-73 with low dose (5mg) donepezil (Aricept®), will show a significantly improved clinical outcome versus when the drugs are administered individually. ANAVEX PLUS is expected to show up to 9 points improvement in ADAS-Cog at 12 weeks and 6 points at 26 weeks in mild-to-moderate Alzheimer’s patients, respectively, at target engagement levels of approximately 70%. When administered alone, ANAVEX 2-73 is expected to improve ADAS-Cog by 5 points at 12 weeks, and 3 point at 26 weeks, which is also likely to be detected clinically. As a point of reference, in human clinical trials 5 mg donepezil (Aricept®) was reported to show an average improvement of 3.6 points ADAS-Cog at 12 weeks and 2.6 at 26 weeks, respectively.
“This data, as reported in IPI Journal, confirms the strong synergy we have previously seen preclinically between ANAVEX 2-73 and donepezil. It also supports the advancement of ANAVEX PLUS into a Phase 1b/2a trial,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “The same type of computer model is in use by big pharmaceutical companies to predict the difference between rodent and human brains as well as the anticipated clinical trial outcome. Therefore, the computer simulation model is believed to have reduced the trial risk for ANAVEX PLUS.”
The report, entitled “The Anticipated Clinical Effect of the new Alzheimer Drug ANAVEX PLUS in a Predictive Humanized Cortical Cognitive Model for Alzheimer’s Disease,” was co-authored by Drs. Missling, Maurice and Geerts, Chief Scientific Officer of In Silico BioSciences (ISB) and Adjunct Professor at the School of Medicine at the University of Pennsylvania, along with industry colleagues.
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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