Anavex Reports Predicted Clinical Effect for ANAVEX 2-73 in Computer Simulation Model of Alzheimer's Disease Study Presented at CNS Summit 2013 Suggests ANAVEX 2-73 Will Have Clinically Detectable and Meaningful Effect in Alzheimer's Disease, Especially When Combined With Aricept®
NEW YORK, Nov. 18, 2013 /PRNewswire/ -- Anavex Life Sciences Corp. ("Anavex" or the "Company") (OTCQB: AVXL) presented new data from a study evaluating ANAVEX 2-73 in a computer simulation model of Alzheimer's disease (AD) limited to symptomatic effects, which was presented during a poster session at the CNS Summit 2013 on Saturday, November 16th, 2013 in Boca Raton, Florida.
The results from the poster, entitled, "The anticipated clinical effect of the new Alzheimer drug ANAVEX 2-73 in a calibrated Quantitative Systems Pharmacology Platform", predict that ANAVEX 2-73, in a realistic cortical network computer model of AD, will show a clinical dose-dependent improvement in AD Assessment Scale – Cognitive (ADAS-Cog) of 2-3 points at 12 weeks, which is similar to Aricept® (donepezil), currently the best-selling Alzheimer's drug with reported sales of $4 billion last year. However, when combining ANAVEX 2-73 with low dose (5mg) Aricept® (donepezil), the clinical outcome significantly improves, to a maximal effect of anticipated ADAS-Cog response of 6-7 points at 12 weeks and 4.5-5.5 points at 26 weeks in mild-to-moderate AD patients, respectively. These improvements suggest the effects will likely be clinically detectable and meaningful.
Tangui Maurice, PhD, CNRS Research Director at the University of Montpellier and INSERM, said, "This data confirms the significant and unexpected synergy we have previously seen between ANAVEX 2-73 and Aricept® (donepezil) in a preclinical model. This result allows us to confidently move forward into the analysis of this potentially promising combination drug for Alzheimer's disease."
Hugo Geerts, PhD, Chief Scientific Officer of In Silico BioSciences (ISB) and Adjunct Professor at the School of Medicine at the University of Pennsylvania, stated, "We don't have many examples of blinded predictions using our Quantitative Systems Pharmacology platform, only three so far, however, in those three cases the respective sponsor performed a clinical trial that essentially confirmed our unexpected quantitative predictions, and the respective outcomes were published."
Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex, said, "The data is quite encouraging since the study focused purely on symptomatic effects and no sigma-1 effect was implemented or considered. With this study we added another layer of positive evidence to advance ANAVEX 2-73 in combination with donepezil into clinical trials."
The poster was co-authored by Dr. Maurice and Dr. Geerts, as well as Athan Spiros, PhD, Chief Technology Officer at ISB; and Patrick Roberts, PhD, Director of Computational Systems Pharmacology at ISB and Adjunct Professor in Biomedical Engineering at Oregon Health & Science University and Systems Science Program at Portland State University.
The full poster is available on the Anavex website at http://anavex.com/publications.html.
About In Silico Biosciences Inc.
In Silico Biosciences has been building mechanistic mathematical models of physiological systems of CNS diseases such as Alzheimer's, schizophrenia and Parkinson's diseases since 1999. The integration of current knowledge from many sources is applied so as to better understand the systemic behavior of the disease physiology in the human vs. the animal brain. A multiplicity of validation methodologies are utilized for these patent protected models.
About ANAVEX 2-73
ANAVEX 2-73 is an orally available small molecule being investigated for the treatment of Alzheimer's disease. In addition to pre-clinical data indicating that ANAVEX 2-73 has the potential to prevent, halt and/or reverse the course of Alzheimer's disease, there was also a highly encouraging synergistic effect observed between ANAVEX 2-73 and Aricept® (donepezil). The combined therapeutics produced up to 80% greater reversal of memory loss in Alzheimer's disease models versus when the drugs were used individually.
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, a 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. 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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