FDAnews
www.fdanews.com/articles/90944-memory-pharmaceuticals-announces-release-of-clinical-hold

MEMORY PHARMACEUTICALS ANNOUNCES RELEASE OF CLINICAL HOLD

December 12, 2006

Memory Pharmaceuticals announced that the FDA has completed its review of the investigational new drug application (IND) for MEM 3454 and has informed the company that the clinical hold on the development of this drug candidate has been released. The company now plans to commence its previously announced Phase IIa clinical trial for MEM 3454 in Alzheimer's disease during the first quarter of 2007.

"Memory has worked diligently with the FDA since this trial was placed on clinical hold in October, and we are pleased that we will now be able to move forward with the proof-of-concept trial for this important drug candidate," Jim Sulat, president and CEO of Memory Pharmaceuticals, said.

When the FDA placed the trial on hold, the agency advised the company that in order to fully review the toxicology reports that were submitted with the IND, the agency would require further explanations of revisions that were made since they were submitted with the company's first IND in May. The FDA also deferred assessment of the adequacy of the investigator's brochure for the trial pending submission of the additional information.

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, according to the company. Memory Pharmaceuticals is developing MEM 3454 as potential therapy for Alzheimer's disease and is considering developing the compound as a treatment for schizophrenia.