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Memory Pharma to conduct study of MEM 3454 for schizophrenia
Montvale, New Jersey | Thursday, February 21, 2008, 08:00 Hrs  [IST]

Memory Pharmaceuticals Corp. unveiled plans to conduct a clinical study of MEM 3454, the company's lead nicotinic alpha-7 partial agonist, on two biomarkers of schizophrenia, P50 sensory gating and mismatch negativity, in patients with schizophrenia. The biomarker study, and additional formulation and manufacturing activities for MEM 3454, will be funded by Roche, under the companies' collaboration for the development of nicotinic alpha-7 receptor agonists.

"This new study will greatly enhance our ability to measure and predict the efficacy of MEM 3454 and other compounds in the nicotinic alpha-7 receptor programme," said Stephen Murray, MD, Ph.D, chief medical officer, Memory Pharmaceuticals Corp. "The study should be underway this summer with data available by early 2009. The biomarker data, together with the results of our ongoing phase IIa study in CIAS, will help with the design of later-stage trials in schizophrenia."

The biomarker study will enrol approximately 12 patients with stable schizophrenia who are receiving atypical antipsychotic therapy. Subjects will be randomized to receive MEM 3454 and placebo in a 5-way cross-over design. Each subject will participate in 5 treatment periods. During each period, subjects will receive single doses of 1 mg, 5 mg, 15 mg, or 50 mg of MEM 3454 or placebo, with a 4-day wash-out period between each treatment period. The primary objective of the trial is to study P50 sensory gating and mismatch negativity as potential efficacy biomarkers for nicotinic alpha-7 agonists, such as MEM 3454, in schizophrenia. P50 sensory gating and mismatch negativity are two neurophysiological measurements that have been shown to be closely associated with nicotinic alpha-7 function and schizophrenia.

In November 2007, Memory Pharmaceuticals announced positive phase IIa data from a clinical trial of MEM 3454 in Alzheimer's disease. MEM 3454 demonstrated a statistically significant effect on cognition at the 5 mg and 15 mg doses on both the primary and key secondary endpoints for that trial. Roche has an option to a worldwide, exclusive license to develop and commercialize MEM 3454 upon the delivery by Memory of the study report of the phase IIa AD study and the fulfilment of certain additional predefined events. Roche is obligated to make a milestone payment to Memory Pharmaceuticals at the time this option is exercised.

In December 2007, as part of the development programme for MEM 3454 in schizophrenia, Memory Pharmaceuticals commenced a phase IIa clinical trial of MEM 3454 in CIAS. To maintain its license to MEM 3454, Roche would have to make an additional milestone payment to the company upon completion of the ongoing phase IIa CIAS trial, which is expected to be completed in the fourth quarter of 2008.

MEM 3454 is a partial agonist of the nicotinic alpha-7 receptor, a highly specialized receptor found in the central nervous system. Compounds acting on this receptor could be beneficial in the treatment of Alzheimer's disease and schizophrenia, as well as other psychiatric and neurological disorders. MEM 3454 is being developed by Memory Pharmaceuticals under its Strategic Alliance Agreement with Roche for the development of nicotinic alpha-7 receptor agonists and is the Company's lead drug candidate from its nicotinic alpha-7 agonist programme.

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