EnVivo Pharmaceuticals Announces Progress on Major Drug Programs Focusing on Alzheimer’s, Schizophrenia and Huntington’s Diseases
October 17, 2007
WATERTOWN, Mass., October 17, 2007 — EnVivo Pharmaceuticals, Inc., a privately held biopharmaceutical company developing drugs for neurodegenerative diseases, today announced progress on several key programs for addressing Alzheimer’s, Schizophrenia and Huntington’s diseases.
EnVivo Pharmaceuticals is developing EVP6124, a selective, orally active Alpha 7 Nicotinic Acetylcholine Receptor Agonist for the treatment of cognitive deficits associated with Alzheimer’s disease and Schizophrenia. The Company today announced the commencement of a second Phase I multiple ascending dose study in healthy young volunteers at very low doses to further establish safety factors and evidence of cognitive enhancement. In previously completed Phase I studies a positive signal consistent with the mechanism of action and suggestive of a pro-cognitive effect was shown.
In a related matter, the Company announced approval of an Investigational New Drug (IND) Application from the U.S. Food and Drug Administration for a Phase IIA Schizophrenia study that is scheduled to begin in early 2008. It is anticipated that Alpha 7 agonist compounds will improve cognitive function in Schizophrenia and Alzheimer’s patients.
Additionally, the Company reported that a lead compound has emerged from its Histone Deacetylase Inhibitor (HDACi) program. The goal of the program is to further evaluate this lead compound with a view to potentially commencing clinical trials in 2008, in mutual agreement with partner MethylGene. The company believes that this lead compound represents one of the first highly potent, orally bio-available and brain-permeable HDAC inhibitors for neuro-degenerative diseases. HDAC inhibitors hold promise for treating the cognitive deficits of several diseases including Alzheimer’s disease and Parkinson’s Disease as well as slowing the progression of neuro-degenerative diseases such as Huntington’s disease.
Finally, the Company announced the appointment of Maria S. Gawryl, 53, as Senior Director and program executive for the Alpha 7 initiative. Dr. Gawryl has more than 20 years of pharmaceutical experience with companies such as RenaMed Biologics, Biopure Corporation, Baxter and Bioscience associates, as well as research experience at academic institutions such as Harvard and Yale University School of Medicine. She has executed and completed numerous multinational clinical trials and over 250 preclinical studies. She holds a Bachelor of Science in Chemistry and Mathematics from Antioch College, a Ph.D. in Immunology/Biomedical Sciences from the University of Connecticut and completed post-doctoral research at Rush Medical College in Chicago.
“Our Company is continuing to make steady progress across all programs of our pipeline, so we are privileged to have such an experienced clinical pharmacologist join our teams to further advance these important programs into later-stage clinical trials” stated Kees Been, EnVivo’s President and Chief Executive Officer.
EnVivo Pharmaceuticals is a biopharmaceutical company dedicated to discovering and developing drugs for central nervous system (CNS) disorders including, Alzheimer’s disease, Parkinson’s disease and Huntington’s disease. The company’s lead programs include a Nicotinic Acetylcholine Receptor Agonist Program (alpha-7) for Alzheimer’s disease and Schizophrenia, a Histone Deacetylase Inhibitor (HDACi) Program for Huntington’s disease and several other programs such as theEVP2442 program for neuro-protection and the PDE10 inhibitor and gamma-secretase modulator programs.