Anavex Life Sciences Corp., Hoboken, N.J., announced that the first healthy human volunteers have been initially dosed in its Phase I clinical trial to evaluate ANAVEX 2-73, the company’s lead compound for Alzheimer’s disease.
“We are pleased that the first volunteers have been dosed with the study drug, according to the study protocol, and no adverse events have been recorded post dosing to date,” said Ozkan Yalkinoglou, medical director of ABX-CRO.
“ANAVEX 2-73 is a proprietary, wholly owned drug that comes from a family of compounds discovered and developed in-house. Its first-in-human administration is the most significant and important milestone in our corporate history. We eagerly anticipate the results of this Phase I clinical trial,” said Cameron Durrant, executive chairman of Anavex.
“There is a significant need for new and effective oral treatments for Alzheimer’s disease. Based on several preclinical animal studies, we believe ANAVEX 2-73 is a promising new anti-Alzheimer’s compound that has the potential to directly address the pathology of Alzheimer’s disease, potentially halting or even reversing its course,” said Dr. Angelos Stergiou, Vice President of Clinical Development & Medical Affairs for Anavex.
The Phase I clinical trial is being conducted in Germany in collaboration with ABX-CRO, which has conducted several Alzheimer’s disease studies, and the University of Dresden. Dosing of at least 16 healthy volunteers is expected to be complete in approximately three months.
This Phase I clinical trial is a randomized, placebo-controlled study to initially test ANAVEX 2-73 as a single, ascending oral dose in healthy volunteers. The trial seeks to determine the maximum tolerated single dose, safety, pharmacokinetics (the mechanisms of absorption and distribution of the drug, the rate at which a drug begins to act and the duration of its effect, as well as chemical changes of the substance in the body) and pharmacodynamics (physiological effects of drugs on the body, mechanisms of action and relationship between drug concentration and effect).
Date: April 20, 2011
Source: Anavex Life Sciences Corp.
Filed Under: Drug Discovery
