Anavex Life Sciences announced that they have established an agreement with The Roskamp Institute for the clinical development of ANAVEX PLUS, a new combination drug of ANAVEX 2-73 and donepezil (Aricept®) for the treatment of Alzheimer’s disease. This study will evaluate the safety, tolerability, pharmacokinetics, and possible clinical benefits of ANAVEX PLUS in Alzheimer’s disease patients and other diseases associated with dementia and cognitive impairment.
ANAVEX PLUS is a proprietary drug combination of ANAVEX 2-73 with donepezil (Aricept®) as a potential novel combination drug for Alzheimer’s disease. Aricept® (donepezil) is now generic. ANAVEX 2-73 showed in combination with Aricept® (donepezil) results for memory improvement by up to 80% in animal models. A patent application was filed in the US for the combination of ANAVEX PLUS and, if granted, would extend at least until 2033. In a humanized calibrated cortical network computer model ANAVEX PLUS showed an ADAS-Cog response of 7 points at 12 weeks and 5.5 points at 26 weeks. These data represent more than twice the ADAS-Cog response exhibited by donepezil (Aricept®) alone.
"The support by The Roskamp Instititute shows the confidence in this new therapeutic approach for Alzheimer’s disease to develop innovative treatments for the many unmet needs of patients with this disorder," said Christopher U. Missling, PhD, Anavex's President and Chief Executive Officer. "It also underscores Anavex’s deep commitment in the development of novel therapeutics for diseases of the central nervous system.”
Fiona Crawford, PhD, President of The Roskamp Institute, said,
“ANAVEX PLUS has shown promising pre-clinical data and represents a novel approach for the treatment of Alzheimer’s disease and we are excited to work with the Anavex team.”
About the Roskamp Institute
The Roskamp Institute, located in Sarasota, Florida, is devoted to understanding causes and finding cures for neuropsychiatric and neurodegenerative disorders and operates a clinic and clinical research office. The Institute utilizes a broad range of scientific approaches to understanding the causes of and potential therapies for these disorders with an emphasis on Alzheimer's disease. From this work novel treatments developed by the Roskamp Institute are in clinical trials in Europe and the U.S.
About Alzheimer’s Disease and Other Disorders of Cognitive Impairment
Today there is significant unmet medical need and heavy economic burden across multiple diseases characterized by cognitive impairment and dementia. In Alzheimer’s disease, currently available drugs provide limited and transient effects on cognition. Healthcare costs associated with the epidemic of Alzheimer’s, including nursing home care, continue to grow dramatically and new therapies with better and more durable efficacy are urgently needed.
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 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.