VANCOUVER, May 6, 2013 /PRNewswire/ - Anavex Life Sciences Corp. ("Anavex") (OTCQB: AVXL) today announced that it has been invited to submit a full grant application to the Alzheimer's Drug Discovery Foundation ("ADDF") for a Phase 2a trial of ANAVEX 2-73. Since 1998, the ADDF has granted more than $51 million in venture philanthropy funding to projects with potential viability in the market. Subsequent to the ADDF's initial funding, grantees have received commitments of over $2 billion in follow-on funding from government, pharmaceutical companies and venture capital firms to further advance their drugs.
"We are excited by this invitation to submit a funding application for a Phase 2a trial of ANAVEX 2-73," said Tom Skarpelos, director of Anavex. "The data generated for ANAVEX 2-73 to date indicates that it has the potential to prevent, halt and/or reverse the course of Alzheimer's disease, which could improve the lives of millions of Americans."
In pre-clinical studies, ANAVEX2-73 demonstrated cognitive benefit, the ability to protect neurons to prevent cell death, and a clear synergic effect with Aricept® (donepezil HCl), a leading, FDA-approved Alzheimer's treatment. A Phase 1 human clinical trial of ANAVEX 2-73 has also been successfully completed.
The objective of the proposed Phase 2a clinical trial is to demonstrate objective biomarker data that can be correlated to clinical findings. It would also seek to confirm the pre-clinical synergy observed when combining ANAVEX 2-73 with donepezil in patients with Alzheimer's disease. Data generated would help determine the decision to proceed to a larger Phase 2 trial.The invitation to submit a full application was received following the filing by Anavex of a Letter of Intent for a grant titled, "Clinical phase 2a study of ANAVEX 2-73 in patients using FDG-PET imaging as a functional biomarker." Anavex now intends to file a full application with the ADDF. There can be no assurance that the Company's application for a grant from the ADDF will be approved.