Anavex Announces Positive Preclinical Data for ANAVEX 2-73 in Infantile Spasms
Detailed Data to be Presented at Upcoming Scientific Meeting
NEW YORK – May, 18 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, announces today that treatment with ANAVEX 2-73 significantly reduced the number of spasms in an animal model with infantile spasms (epileptic spasms) in infant rats.
In the preclinical study, following prenatal priming with betamethasone in infant rats, spasms were recorded for 90 minutes following postnatal trigger of spasms with NMDA injection. Treatment with ANAVEX 2-73 significantly reduced the number of spasms by 55 percent compared to vehicle (p=0.0002).
The study was sponsored and performed by Libor Velisek, MD, PhD, Professor of Cell Biology & Anatomy, Pediatrics, and Neurology and his laboratory at New York Medical College (NYMC).
“Our team has tested many different compounds with strong rationale for potential effect in infantile spasms. However, ANAVEX 2-73 is by far the only highly effective compound we have worked with apart from the adrenocorticotropic hormone (ACTH),” said Dr. Velisek. “I believe that a continuation of studies with ANAVEX 2-73 is fully justified.”
The infantile spasms rat model represents a clinically relevant animal model of infantile spasms since the phenotype is developmentally specific and semiologically similar to human infantile spasms, including clustering of spasms. The phenotype of spasms persists only up to 21 days of age in rats (correlating with human infancy and early childhood). Further, EEG features correspond well to human infantile spasms, with interictal high amplitude asynchronous waves similar to hypsarrhythmia and ictal EEG suppression similar to electrodecrements.
“The positive preclinical signal in infantile spasms is encouraging evidence of beneficial effects of ANAVEX 2-73 in another rare disease and we plan to further explore seizure reductions as measurement outcomes in future clinical trials,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex.
About Infantile Spasms
A rare yet devastating condition, infantile spasms is a seizure disorder that typically occurs during the first 4-11 months of childhood. Infantile spasms represent a major issue as they are resistant to treatments, they have dire consequences in terms of delayed development, progression into other devastating epilepsy syndromes and those partially effective treatments have serious side effects, including death. Infantile spasms usually stop by age five, but may be replaced by other seizure types. Many underlying disorders, such as birth injury, metabolic disorders, and genetic disorders can give rise to spasms, making it important to identify the underlying cause. In many children, no cause can be found.
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 (MJFF) 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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