The Alzheimer's Drug Discovery Foundation and Charles River : Collaboration to Create a New Cognitive Aging Research Program

July 12, 2011 -- The Alzheimer's Drug Discovery Foundation (ADDF) is pleased to announce a collaboration with Charles River Laboratories International, Inc. (NYSE: CRL), a leading provider of early-stage drug development products and services, for the creation of a new research award program entitled Use of Aged Rats as a Relevant Preclinical Model for the Development of Therapies for Cognitive Aging and Alzheimer's Disease. The program is made possible through a donation from Charles River's Discovery Services business and funds from the ADDF.

The goal of the three-year initiative is to accelerate the discovery of new drugs for cognitive aging and Alzheimer's disease. The program will fund preclinical studies focused on proof-of-concept testing of novel compounds in aged rats. Academic and biotechnology company scientists are invited to apply to the program, which will provide funding of up to $150,000 for one-year. The deadline for submissions is October 5, 2011, and funding will be awarded in December 2011...[PDF] Alzheimer's Drug Discovery Foundation's Press Release -

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 -

YUMA THERAPEUTICS AWARDED A RESEARCH GRANT BY THE ALZHEIMER’S DRUG DISCOVERY FOUNDATION TO DEVELOP NOVEL THERAPEUTICS FOR ALZHEIMER’S DISEASE

March 28, 2011 – The Alzheimer’s Drug Discovery Foundation (ADDF) announced that it has awarded a grant of $249,810 to Yuma Therapeutics Corporation (Yuma) to develop small molecules to treat Alzheimer’s disease.
The award will fund work to develop Yuma’s innovative disease-modifying pharmaceutical compounds that target neurofibrillary tangles resulting from abnormal forms of the protein tau, which represents a promising new approach with potential to affect disease progression in Alzheimer’s disease... [PDF] Alzheimer’s Drug Discovery Foundation's Press Release -

Axxam : Research Grant by the Alzheimer’s Drug Discovery Foundation to develop Novel Therapeutics for Alzheimer’s Disease

June, 22nd 2011 - Axxam awarded a Research Grant by the Alzheimer’s Drug Discovery Foundation to develop Novel Therapeutics for Alzheimer’s Disease
The Alzheimer’s Drug Discovery Foundation (ADDF) and Axxam SpA entered a collaboration to develop small molecules to treat Alzheimer’s disease by targeting inflammation.
Under the terms of this agreement, Axxam will screen its extensive chemical library to identify compounds that block the puringeric receptor, P2X7, which is involved in inflammation in the brain.
One of the characteristic features of Alzheimer’s disease is a robust inflammatory response involving over-activation of specialized brain cells called microglia and the release of pro-inflammatory signals associated with the deposition of Alzheimer’s disease plaques in the brain. These pro-inflammatory signals are closely associated with the P2X7 receptor, putting this novel target at the heart of brain inflammation.
Compounds that block P2X7 may treat brain inflammation and can potentially be useful in the treatment of Alzheimer’s disease and other neurodegenerative diseases... [PDF] Axxam's Press Release -

Clarimedix : Treatment Targets Alzheimer's Symptoms with Non-Invasive, Non-Drug Device

March 7, 2011 - Clarimedix presents non-drug, non-invasive technology findings at International AD/PD Conference - Clarimedix Inc., ...results of recently completed animal studies on its groundbreaking, non-invasive treatment of Alzheimer's disease at the International Conference of the AD/PD (Alzheimer's Disease/Parkinson's Disease) Conference in Barcelona on March 9.
"We will describe how our technology is paving the way for what we believe will make Alzheimer's a controllable and treatable disease," says John Dunning, CEO and president of Clarimedix. "This has the potential to revolutionize Alzheimer's treatment options for patients and families."
The Clarimedix technology is a light-based medical device in the form of a flexible patch that is applied to the skin over the carotid artery. Using a proprietary wavelength and duration of light developed by Clarimedix, the device emits light through the skin and tissue down to the carotid artery. It then triggers targeted, localized and controllable production of nitric oxide, a well-known vasodilator and neurotransmitter capable of increasing blood flow, reducing inflammation and triggering gene expression changes in the brain...Clarimedix : recent news -

Mylan : Approval for Generic Version of Aricept® Tablets

June 7, 2011 - Mylan Inc. (Nasdaq: MYL) announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Donepezil Hydrochloride (HCl) Tablets, 5 mg and 10 mg, the generic version of Eisai's Aricept® Tablets, which are used to treat dementia associated with Alzheimer's disease.

Donepezil HCl Tablets had U.S. sales of approximately $2.3 billion for the 12 months ending March 31, 2011, according to IMS Health. Mylan Pharmaceuticals Inc. is launching this product immediately.



Currently, Mylan has 164 ANDAs pending FDA approval representing $95.6 billion in annual sales, according to IMS Health. Forty-five of these pending ANDAs are potential first-to-file opportunities, representing $25.8 billion in annual brand sales, for the 12 months ending Dec. 31, 2010, according to IMS Health... Mylan's Press Release -