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Wednesday, July 13, 2011

EnVivo : Initiation of Gamma Secretase Modulator Clinical Program in Alzheimer’s Disease

EnVivo PharmaceuticalsJune 27, 2011 - Phase 1 Trial of EVP-0962 Underway; Study Builds Upon Strong Preclinical Findings in Models of Alzheimer’s Disease - EnVivo Pharmaceuticals, a company dedicated to developing a broad range of novel central nervous system (CNS) therapies, announced that it recently initiated a Phase 1 clinical trial of EVP-0962, its potent and selective gamma secretase modulator (GSM), in healthy volunteers. The trial is a double-blind, ascending single and multiple dose study designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of EVP-0962. To date, EVP-0962 has shown promising activity in preclinical cellular and transgenic models of Alzheimer’s disease.

“This launch of our clinical studies of EVP-0962 marks an important step forward for the program as we continue to build upon our foundation of encouraging preclinical data,” said Dana C. Hilt, M.D., senior vice president, clinical development and chief medical officer of EnVivo. “In preclinical studies, EVP-0962 has demonstrated a significant reduction in amyloid plaques, which are believed to be a cause of Alzheimer’s disease, and reversed behavioral deficits. We are encouraged by these findings and believe that gamma secretase modulators like EVP-0962 could represent the next generation of novel, disease modifying treatments for patients with Alzheimer’s.\"

EVP-0962 is a proprietary small molecule that has been shown to selectively modulate gamma secretase, a key enzyme involved in the processing of amyloid and its toxic AB1-42 peptide, which is a key component of amyloid plaques in the brain... EnVivo Pharmaceuticals' Press Release -