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Inflazyme receives Helicon's statement regarding preliminary results of IPL455,903 in Phase 2a memory study
Inflazyme Pharmaceuticals Ltd. receives a statement from Helicon Therapeutics of New York regarding the outcome of the proof of concept Phase 2a study with IPL455,903 (HT-0712) in Age Associated Memory Impairment (AAMI).
"(IPL455,903) was evaluated in a double-blind, randomized placebo controlled study to assess the safety, tolerability, preliminary efficacy and pharmacokinetics of a range of oral daily doses of (IPL455,903) given over a 28-day period in subjects with AAMI."
"This safety study was completed in March 2007 and the compound appears safe and well tolerated at all doses tested (up to 15-90 mg per subject per day). The daily administration resulted in sustained drug levels, consistent with earlier studies. Top line results showed that (IPL455,903) continues to lack the emetic property and adverse cardiovascular profile that has limited clinical development of many PDE-4 inhibitors. Although the effects on memory and learning failed to show a positive statistical effect, this is not surprising considering the limited study duration and the number of subjects enrolled per dose group. However, preliminary indications are that (IPL455,903) did not show efficacy or signal on Quantitative (electroencephalogram) EEG."
The statement provided by Helicon was not accompanied by any data or preliminary reports. Inflazyme has requested data and reports on this study and Helicon has indicated that it expects to provide a report to the company by the end of April 2007. Consequently, Inflazyme is not able to independently assess and interpret the outcome of the study.
Dr. Kevin Mullane, CEO and president of Inflazyme, said, "We recognize this information is preliminary and incomplete. However, in the interest of full and complete disclosure we are informing the markets of Helicon's statement. We look forward to receiving the full report in a few weeks time and then we will be able to provide further guidance to the markets."