Anavex Life Sciences Corp., has commenced the 30 mg dose step in its ongoing phase I clinical trial to evaluate Anavex 2-73, the company’s lead drug candidate for Alzheimer’s disease. This is the third of six potential dose steps and follows the successful completion of the 1 mg and 10 mg dosing rounds. There have been no adverse effects recorded after the administration of Anavex 2-73 at the doses studied to date.

Trial participants are receiving single, ascending oral doses of Anavex 2-73 with one group potentially advancing to a maximum single oral dose of 240 mg. To that end, the Anavex 2-73 phase I trial is rapidly and positively advancing.

Positive safety data at lower doses has so far enabled the company to skip one higher dosing step and increase the amount being administered by ten times, from 1 mg to 10 mg, instead of from 1mg to 5mg. This recommendation was unanimously recommended by the Safety Review Committee for Anavex 2-73 following their evaluation of the available safety data from the first group of healthy human volunteers in the initial dose step.

After each dose step, the Safety Review Committee meets to discuss the safety data in a blinded manner and determine whether the next higher dose should be administered. The committee bases its decision on clinical safety and tolerability data and on laboratory and available pharmacokinetic data (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) from the preceding dose step(s). In addition, each volunteer is contacted by phone for a further safety check on day seven following drug administration. Preclinical data is also considered.

Data from the phase I trial is expected to build upon the excellent safety profile of Anavex 2-73 in preclinical studies conducted with mice, rats and dogs. In addition to a favourable safety profile to date, preclinical studies of Anavex 2-73 have already generated evidence of improving and reversing the memory and learning deficits in animal models which may mimic the effects of Alzheimer’s disease. Specifically, there is evidence of ‘neuroprotection’ -- in other words certain brain cells that are ordinarily lost in these animal models are preserved.

The primary objective of the phase I clinical trial is to evaluate the safety and tolerability of Anavex 2-73 in humans for the first time. The secondary objective of the phase I trial is to determine the pharmacokinetic profile of single oral ascending doses of Anavex 2-73.

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 male volunteers between the ages of 18 and 55. The trial seeks to determine the maximum tolerated single dose, safety and pharmacokinetics.

The phase I clinical trial is being conducted in Germany in collaboration with ABX-CRO, a clinical research organization that has conducted several Alzheimer’s disease studies, and the Technical University of Dresden.