Orasi Medical : Clinical Results on Alzheimer's Disease Severity

July 18, 2011 – Orasi Medical, Inc., a leading neurodiagnostic company utilizing magnetoencephalography (MEG) to revolutionize the diagnosis and management of CNS diseases, announced today the publication of clinical results demonstrating the use of MEG to assess and track Alzheimer’s disease (AD) severity. The findings will be published in the July issue of the Journal of Alzheimer’s Disease. The paper also will be published as a chapter in the Handbook on Imaging the Alzheimer Brain, which will be released at the International Conference for Alzheimer’s Disease (ICAD) Paris, July 15-21, 2011.

The paper describes the results of two exploratory, case-controlled studies in which a cohort of 117 AD patients and 123 elderly, cognitively normal volunteers was recruited from community neurology clinics in Denver, Colorado and Minneapolis, Minnesota. Brain function was measured by a brief, resting-state, eyes-open MEG scan, and subjects were evaluated with a neurological examination, medical history, and a battery of standard neuropsychological tests. Cross-sectional analysis of MEG scans revealed that AD patients exhibited global changes in relative spectral power indicative of generalized slowing of brain signaling and altered patterns of functional connectivity globally and locally. Many changes detected by MEG accurately tracked cognitive decline as measured independently by neurospsychological tests... Orasi Medical's Press Release -

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

June 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 -

Osta Biotechnologies : PROMISING RESULTS ON NEW EXPERIMENTAL DRUG FOR ALZHEIMER’S DISEASE

April 19, 2011 - Osta Biotechnologies Inc. announced the results of a preclinical study on its novel compound, OB-28 in an Alzheimer’s disease animal model. Data from this study showed statistically significant amelioration of behavioral deficits in a transgenic mouse model of Alzheimer’s disease treated with OB-28. Funding for this study was provided by an affiliate of the Alzheimer’s Drug Discovery Foundation (ADDF).

These findings represent an important milestone in Osta's plan to develop novel drugs for the treatment of Alzheimer’s disease and provide an important advancement towards generating sufficient pre-clinical data in order for the company to advance towards IND filing.

Results of the Pre-Clinical Study

The pre-clinical study was conducted in collaboration with Dr. Donald Ingram, Professor, Nutritional Neuroscience and Aging Laboratory and Director, Animal Metabolism and Behavior Core, Pennington Biomedical Research Center, a research campus of the Lousiana State University. In this study, a total of 103 wild type (wt) and double transgenic 3 month old mice (APPswe/PS1dE9; dTg) were treated with either saline, memantine (10 mg/kg/day) or OB-28 at doses of 15 mg/kg/day and 30 mg/kg/day via daily intra-peritoneal injections over a period of 4 months and the behavioral deficits in the wt and dTg mice were assayed using the Stone T-maze (STM) test as well as contextual and tone fear conditioning tests... [PDF] Alzheimer’s Drug Discovery Foundation's Press Release -