Hawthorn Pharmaceuticals : Alzheimer's Global Licensing Deal with CoPlex Therapeutics

September 6, 2011 – Hawthorn Pharmaceuticals, Inc. announced an exclusive global licensing deal with CoPlex Therapeutics on hawAD14, a preclinical oral small molecule candidate for the treatment of Alzheimer's and other neurodegenerative diseases.

 Under the terms of the agreement, Hawthorn will receive an exclusive worldwide license to develop and commercialize hawAD14 and will be responsible for funding all future development.

 Research indicates hawAD14 significantly decreases levels of Amyloid Beta (Aß) and tau phosphorylation activity, the main constituents of amyloid plaques and paired helical filaments that make up neurofibrillary tangles in Alzheimer's disease... Hawthorn Pharmaceuticals' Press Release -

Evotec and Roche agree to develop compound that could slow the progression of Alzheimer's disease

5 September 2011: Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX) and Roche AG (SIX: RO, ROG; OTCQX: RHHBY) announced that they have entered into an exclusive worldwide agreement for the development and commercialization of Evotec's MAO-B inhibitor in patients with Alzheimer's disease (AD).
 

Under the terms of the agreement, Roche will pay Evotec an upfront fee of $10 million. Evotec could receive further development and commercial milestone payments of up to $820 million as well as tiered double-digit royalties on sales. Roche will initiate studies in 2012 to demonstrate proof of concept and will be responsible for all clinical development, manufacturing and commercialization activities.

Evotec's compound (EVT 302) is a novel, potent inhibitor of monoamine oxidase type B (MAO-B), an enzyme that breaks down the chemical messenger dopamine in the brain and contributes to the production of free radicals. Free radicals are known to cause oxidative stress which may contribute to pathogenesis of AD as demonstrated by the up-regulation of MAO-B expression in the brain of AD patients. For these reasons, the selective MAO-B inhibitor is targeted to treat AD symptoms and potentially slow disease progression... Evotec's Press Release -

AMRI : NIH Contract Award for the Development of Pre-Clinical Drug Candidates to Treat Diseases of the Nervous System

August 18, 2011 – AMRI (NASDAQ: AMRI) announced it received a federal contract award from the National Institutes of Health (NIH) / National Institute of Neurological Disorders and Stroke (NINDS) to provide chemistry and other drug discovery technologies in support of NINDS' Medicinal Chemistry for Neurotherapeutics Program (MCNP), part of the NIH Blueprint Neurotherapeutics Network. AMRI has been collaborating with NINDS since 2005 on novel treatments for spinal muscular atrophy, a degenerative neuromuscular disease.

The five-year contract provides AMRI with funding of up to $43 million, based on the number of approved projects and availability of funds. The initial funding of up to $10 million applies to the first phase of the project, expected to begin this month, with the objective of delivering at least one Phase I clinical trial candidate.

“After a highly competitive, rigorous application process, AMRI was selected for this contract award because of our proven track record on projects of similar scope with a number of global pharmaceutical companies. The company's deep bench strength, scale of operations, and strong global footprint enable us to consistently deliver high performance and quality for our clients on a cost-effective basis. This significant award demonstrates the NIH's new focus on helping support the translation of basic research discoveries in areas of unmet medical need to potential drug candidates,” said AMRI's Chairman, President and CEO, Thomas E. D'Ambra, Ph.D.

“We are pleased to support NIH/NINDS' efforts and provide our discovery resources to the neuroscience research community and to patients who suffer from devastating neurological and degenerative diseases, such as macular degeneration and Alzheimer's disease,” added Dr. D'Ambra... AMRI's Press Release -

Rexahn Pharmaceuticals : European Patent granted for Neurotherapeutic Compositions

August 8, 2011 – Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), a clinical stage pharmaceutical company commercializing potential best in class oncology and CNS therapeutics, announced that the European Patent Office (EPO) has granted European patent No. EP1212055 entitled “Neurotherapeutic compositions comprising a beta-lactam compound.”
This patent covers compounds including clavulanic acid and moxalactam for the treatment of neurological disorders such as depression, anxiety, dementia, Alzheimer’s disease and Parkinson’s disease, as well as their use and pharmaceutical formulation... Rexahn Pharmaceuticals' Press Release -

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 -