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news.The FDA has informed Memory Pharmaceuticals that it has reviewed the investigational new drug application for MEM 3454 and the clinical hold on the development of the drug has now been terminated.
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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. The FDA had originally put the product on hold because of concerns about revisions that had been made in a toxicology report by Memory.
“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,” stated Jim Sulat, president and CEO of Memory Pharmaceuticals.
“Given the safety and pharmacokinetic results of the phase I trial for MEM 3454 and the positive cognitive data generated in that trial, we believe that MEM 3454 may offer a new approach for the treatment of debilitating central nervous system disorders.”