Anavex Life Sciences Corp. has provided an update on its ongoing Phase 1 clinical trial to evaluate ANAVEX 2-73, the company’s lead candidate for Alzheimer’s disease. After reviewing all the safety data from the first group of healthy human volunteers in the initial dose step, the Safety Review Committee for ANAVEX 2-73 unanimously approved skipping the 5 mg dose and moving directly to the 10 mg dose step. The next group of eight healthy volunteers was dosed late last week. The clinical trial protocol allowed for the next dose to be studied as either 5 mg or 10 mg, if the safety review warranted the higher dose.
“We are very pleased with the clinical trial data results to date for the safety profile of ANAVEX 2-73,” said Dr. Angelos Stergiou, Vice President of Clinical Development and Medical Affairs for Anavex. “Our Safety Review Committee meets regularly to discuss and review the clinical trial data in a blinded manner. Following an extensive review of the current results, the Safety Review Committee was confident in allowing us to move directly into the 10 mg dose step.”
“I am honored to be the Principal Investigator and a member of the Safety Review Committee for this potential disease-modifying drug, ANAVEX 2-73, in Alzheimer’s disease. The healthy volunteers to date have been successfully dosed according to the study protocol at the Technical University of Dresden and there has been no evidence at all to date of any treatment-related adverse effects. Our Safety Review Committee has reviewed and discussed all data in detail and agreed to proceed to the 10 mg dose stage. With such promising preclinical data I am hopeful that we can continue to advance ANAVEX 2-73 through its development path,” said PD Dr. Christoph Schindler, MD, of the Technical University of Dresden.
The Safety Review Committee is comprised of the following members: PD Dr. Christoph Schindler, Clinical Pharmacologist and Principal Investigator for the ANAVEX 2-73 Phase 1 clinical trial at the Medical Faculty of the Technical University of Dresden, Dr. Juergen Wurziger, MD, the study physician on behalf of ABX-CRO, the Clinical Research Organization running the trial, and Dr. Angelos Stergiou, MD, the responsible study physician for Anavex Life Sciences.
To make its decision, the Safety Review Committee assessed all of the following safety data to date in a blinded manner:
• Laboratory reports of safety data as described in the protocol up to 48 hours (day three) after dosing
• Electrocardiograph (ECG) and vital data as described in the protocol up to 48 hours (day three) after dosing
• A summary on any adverse events that occurred in this dosing group
• Each volunteer is contacted by phone for a further safety check on day seven following drug administration
• The Phase 1 clinical trial is being conducted in Germany in collaboration with ABX-CRO, which has conducted several Alzheimer’s disease studies, and the Technical University of Dresden. Dosing of at least 16 healthy human volunteers is expected to be completed in approximately two months as per the trial protocol.
Date: May 23, 2011
Source: Anavex Life Sciences Corp.
Filed Under: Drug Discovery