Transition Therapeutics : Publication of ELND005 Phase 2 Clinical Study Data in Alzheimer's Disease

September 27th, 2011 - Transition Therapeutics Inc. ("Transition" or the "Company") (TSX: TTH, NASDAQ:TTHI) announced that Phase 2 clinical study data of ELND005 in mild to moderate Alzheimer's disease has been published today in the peer-reviewed journal, Neurology. The Neurology article is entitled "A Phase 2 randomized trial of ELND005, scyllo-inositol, in mild-moderate Alzheimer's disease". In addition, the embargo on the ELND005 Phase 2 data previously presented at the International Conference on Alzheimer's Disease (ICAD) in July 2011 has been lifted and the data can be viewed on our website. Below Transition has summarized the combined data from the article and the presentations.

"Considering that this is a relatively small trial for Alzheimer's disease, we are very pleased with the encouraging phase 2 data. The encouraging clinical signals observed in mild AD patients and evidence of biological activity provides us with important guidance for the selection of dose, patient population, and endpoints for a Phase 3 trial with ELND005." said Dr. Tony Cruz, Chairman and Chief Executive Officer of Transition. "It is also encouraging that the positive effects observed in the mild patient population are consistent with the emerging consensus amongst the scientific community that amyloid targeted disease-modifying therapies may have a higher likelihood of success if intervention occurs early in the Alzheimer's disease process."...Transition Therapeutics' Press Release -

Brainsway : Positive Interim Results in Alzheimer's Trial

27 September, 2011 - Brainsway Ltd. is pleased to announce that it has received additional interim results of a clinical trial being conducted at the Ichilov Medical Center in Israel to explore the efficacy of Deep TMS in the treatment of Alzheimer's disease.

The interim results are for 24 patients that were divided into three groups: a sham stimulation control group, a low-frequency (1 Hz) treatment group and a high-frequency (10 Hz) treatment group. Each subject received treatment over 8 weeks, and the efficacy of the treatment was evaluated both during the trial and over the course of the subsequent 8-week period.

The treatment was well-tolerated by all subjects, with no side-effects, except for one incident involving a sham control subject, which the principal investigator believes to be unrelated to the treatment.

The trial used the Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog) test (the main efficacy scale used in Alzheimer's disease clinical trials), as well as additional accepted scales of disease severity (CGI, ADL, CDR) and a quality-of-life scale (QoL Caregiver Scale) to assess the efficacy of treatment. These are the main assessment scales used to evaluate efficacy in the literature... Brainsway's Press Release -

Alzheimer's Drug Discovery Foundation Supports Madera Biosciences with a Grant to Advance Novel Drug Candidates for Alzheimer's Disease

Aug. 24, 2011 -- The Alzheimer's Drug Discovery Foundation (ADDF) announced that it has awarded a grant of $294,000 to Madera Biosciences, Inc. to develop small molecule drugs designed to clear accumulated beta-amyloid from the brain and thus halt or reverse the progression of Alzheimer's disease.

Madera has identified a series of proprietary compounds that increase the expression of apolipoprotein E (apoE), which has been shown to mediate beta-amyloid clearance from the brain and prevent its accumulation into the plaques that are characteristic of Alzheimer's disease. ApoE is a lipid binding protein that circulates in the blood and the brain and remains the single greatest genetic risk factor for Alzheimer's disease. Increasing the release of apoE from brain cells has actually been shown to decrease beta-amyloid plaques and improve cognitive function in animal models.

Madera's novel, drug-like compounds help to facilitate the release of apoE, aid the beta-amyloid clearance process and are hypothesized to improve symptoms, slow the progression of Alzheimer's disease and potentially reverse the course of the disease. The ADDF's grant will fund Madera's program to optimize these compounds for proof-of-concept testing... Madera Biosciences' News -

Bristol-Myers Squibb Company and Saladax Biomedical, Inc. Expand Collaboration for Diagnostic Assays for Alzheimer’s Disease

September 20, 2011 - Bristol-Myers Squibb Company (NYSE: BMY) and Saladax Biomedical, Inc., announced they have expanded their multi-year agreement covering the development and commercialization of diagnostic assays for the early detection of Alzheimer's disease to include Ortho-Clinical Diagnostics, Inc.

Under the terms of the agreement, the three companies will collaborate globally on the development and regulatory approvals for certain diagnostic assays. Commercialization of the assays will be governed by a separate agreement between Saladax and Ortho-Clinical Diagnostics. Terms of the agreements were not disclosed.

“This expanded collaboration demonstrates Bristol-Myers Squibb’s support of the evolution and continued growth of our neuroscience business and our commitment to Alzheimer’s disease,” said Jane Tiller, vice president, Neuroscience and Global Development Lead, Alzheimer's disease, Bristol-Myers Squibb. “By pursuing the development of validated assays that could assist physicians in the diagnosis of Alzheimer’s disease, we can continue to advance the understanding and treatment of this complex and devastating disease.”

"This strategic alliance shows the value Saladax can bring in the companion diagnostics space and in Alzheimer’s disease specifically... Bristol-Myers Squibb's Press Releases -

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 -