NEW YORK, NY – October 5, 2016 – Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer, today announced a collaboration with Ariana Pharma (Cambridge, MA and Paris, France) to use Ariana’s proprietary KEM® (Knowledge, Extraction, Management) patient stratification technology to potentially accelerate ANAVEX 2-73’s Phase 2/3 Alzheimer’s clinical development timelines. KEM® is a comprehensive and FDA-tested clinical data analysis system that enables full exploitation of complex datasets including of smaller numbers of patients.
“We are very impressed with the rational and efficient clinical trial path Anavex has embarked upon by adopting population pharmacokinetics (PK) and adaptive trial design in its current ANAVEX 2-73 Phase 2a study in Alzheimer’s disease,” said Mohammad Afshar, CEO of Ariana Pharma. “Ariana has the expertise to fully support Anavex’s precision medicine approach to develop more effective treatments for devastating diseases including Alzheimer’s, Parkinson’s and Rett syndrome.”
Ariana specializes in clinical patient stratification using KEM®, a proprietary decision support technology for rapid and systematic analysis of multi-parametric/multi-objective data. Ariana’s technology uncovers signals and complex relationships overlooked by conventional statistical analysis that minimizes the risk of data over-fitting. This approach increases clinical trial success and reduces drug development risks by systematically identifying patient subgroups most benefiting from a drug and endpoints that best capture its effect. Ariana is one of the first companies to implement the new FDA draft enrichment guidelines for patient stratification and trial enrichment. Ariana’s expertise spans multiple medical indications and therapeutic areas, including immunological and neurological diseases and cancer.
Anavex’s 32-patient Alzheimer’s study utilizing KEM® will enable systematic analysis of more data on each patient in the disease group, on par with similar studies of significantly larger size, while providing greater cost and time efficiency.
“The ongoing Phase 2a Alzheimer’s clinical trial was specifically designed to learn as much as possible about ANAVEX 2-73 in order to optimize trial parameters for future pivotal trials and potentially reduce the risk of failure in a later, larger Phase 2/3 study and in a planned Parkinson’s Phase 2 study. We believe that the collaboration with Ariana Pharma will potentially accelerate the development process,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex.
About Ariana Pharma
Ariana Pharma is a leading digital health Company focused on developing advanced therapeutic decision support systems. Ariana’s innovative clinical data analysis and diagnostic testing solutions help the healthcare sector better adapt patient treatments to individual biological characteristics. Ariana Pharma’s KEM® technology enables personalization of therapies, improves the efficacy and safety of patient treatment, reduces risks and drug development costs, and accelerates time to market. KEM® is the only FDA-tested technology that systematically explores combinations of biomarkers, producing more effective biomarker signatures for precision medicine. Ariana has developed Onco KEM®, the most advanced, clinically tested, oncology treatment selection system. Founded in 2003 as a spin-off of the Institut Pasteur, Paris, France, the company opened a subsidiary in the United States in 2012. Further information is available at www.arianapharma.com.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer. Anavex’s lead drug candidate, ANAVEX 2-73, is currently in a Phase 2a clinical trial for Alzheimer’s disease. ANAVEX 2-73 is an orally available drug candidate that targets sigma-1 and muscarinic receptors and successfully completed Phase 1 with a clean safety profile. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy and others. The Michael J. Fox Foundation for Parkinson’s Research has awarded Anavex a research grant to develop ANAVEX 2-73 for the treatment of Parkinson’s disease to fully fund a preclinical study, which could justify moving ANAVEX 2-73 into a Parkinson’s disease clinical trial. ANAVEX 3-71, also targeting sigma-1 and M1 muscarinic receptors, is a promising preclinical drug candidate demonstrating disease modifications against the major Alzheimer’s hallmarks in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies, and also with beneficial effects on neuroinflammation and mitochondrial dysfunctions. Further information is available at www.anavex.com.
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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