Neoprobe Licenses AstraZeneca Imaging Agent for Amyloid Detection to Aid Diagnosis of Alzheimer’s Disease

December 12, 2011 - Neoprobe Corporation (NYSE Amex: NEOP) announced that it has in-licensed the worldwide exclusive rights from AstraZeneca to the late-stage radiopharmaceutical imaging candidate, AZD4694, for aiding the diagnosis of Alzheimer’s disease (AD).

AZD4694 is a Fluorine-18 labeled precision radiopharmaceutical candidate for use in the imaging and evaluation of patients with signs or symptoms of cognitive impairment such as AD. It binds to Beta-amyloid deposits in the brain that can then be imaged in positron emission tomography (PET) scans. Amyloid plaque pathology is a required feature of AD diagnosis and the presence of amyloid pathology is a supportive feature for diagnosis of probable AD. Patients who are negative for amyloid pathology do not have AD.

Clinical studies in more than 70 patients suggest that AZD4694 has the ability to image patients quickly and safely with high sensitivity. Importantly, AZD4694 exhibits low background and white matter uptake, thereby providing clear images of Beta-amyloid deposits. Neoprobe intends to initiate a Phase III clinical program in early 2013, while simultaneously building the requisite safety and training database. Patents and patent applications filed around the world related to AZD4694 are effective until 2028... [PDF] Neoprobe's Press Release -

Dainippon Sumitomo Pharma : launch of Alzheimer's Disease Treatment Donepezil hydrochloride tablets/OD tablets 3mg/5mg “DSP”

November 28, 2011 - Dainippon Sumitomo Pharma Co., Ltd. (DSP) (Headquarters: Osaka, Japan; President: Masayo Tada) announces the launch of Alzheimer's disease treatment Donepezil hydrochloride tablets/OD tablets 3mg/5mg “DSP” in Japan, as of December 2, 2011.

In domestic pharmaceuticals, DSP designates the Central Nervous System field as one of its focus marketing areas, and offers various treatments such as atypical antipsychotics "LONASEN® " and "LULLAN® ", Parkinson's disease drug "TRERIEF® ", norepinephrine-activating neural function ameliorant "DOPS® ", anti-epileptic drug "EXCEGRAN® ", and serotonin-agonist antianxiety drug "SEDIEL® ". Approximately 230 CNS MRs in the CNS Sales & Marketing Division newly established in April 2011 are developing activities to provide information on these products.

DSP decided to handle a CNS generic drug as part of a plan to strengthen its product lineup in the CNS area. On June 24, 2011, DSP created “Established Products & Chain Pharmacies Groups” dedicated to generic drugs in the CNS area under CNS Sales and Marketing, each under the CNS Higashi-Nippon Region, CNS Capital Region, CNS Kinki-Tokai Region and CNS Nishi-Nippon Region with the aim to promote sales of generic drugs in the CNS area... [PDF] Dainippon Sumitomo Pharma's Press Release -

Probiodrug : Top-Line Results of the First Clinical Study of PQ912 for Treatment of Alzheimer’s Disease

November 14, 2011 - Phase 1 Study of the First Glutaminyl Cyclase (QC) Inhibitor, Which Blocks Formation of Highly Neurotoxic pyroGlu Aβ Variants, Shows that PQ912 is Well Tolerated With Therapeutically-Relevant Levels in Blood and Cerebrospinal Fluid –

Probiodrug AG (Probiodrug), a biotech company developing products for the treatment of neurodegenerative and inflammatory diseases, with a particular focus on Alzheimer's disease (AD), today announced top-line results of its Phase 1 single (SAD) and multiple ascending dose (MAD) study of PQ912 in healthy volunteers. PQ912 is a glutaminyl cyclase (QC) inhibitor for the treatment of AD and it is the first QC inhibitor to enter clinical development.

The Phase 1 trial, conducted in Switzerland, demonstrated that PQ912 is safe and well tolerated after oral dosing. Dose-proportional pharmacokinetics and a strong pharmacokinetic and pharmacodynamic relationship based on QC inhibition were observed in plasma and cerebrospinal fluid. The combined SAD/MAD study involved 100 volunteers in a blinded, placebo controlled randomized trial.

PQ912 is a small molecule that targets QC, an enzyme that catalyzes the formation pyroGlu amyloid-beta (Aβ) a highly toxic Aβ variant that is involved in the development and progression of AD. AD is a neurodegenerative disease characterized by deposits of extracellular Aβ plaques in the brain, intraneuronal tangles and cerebral neuronal loss. QC inhibitors address a major pathology associated with AD by inhibiting the formation of Aβ variants which lead to the assembly of highly neurotoxic Aβ-oligomers... Probiodrug's Press Release -

Astellas and RIKEN : Collaborative Research Launched to Explore Novel Drug Targets for Alzheimer’s Disease

November 8, 2011 - RIKEN Brain Science Institute and Astellas Pharma Form Strategic Alliance for New Drug Discovery -

RIKEN, Japan (President: Ryoji Noyori) and Astellas Pharma Inc. (President: Yoshihiko Hatanaka, hereafter called “Astellas”) have signed a five year joint research agreement for the purpose of “deciphering the pathogenic mechanism for and identifying novel drug targets for Alzheimer’s disease”. With the goal of conquering the social burdens of Alzheimer’s disease, synergies between the fundamental research function of RIKEN Brain Science Institute (RIKEN BSI, Director: Susumu Tonegawa) and drug discovery capabilities of Astellas will be leveraged to develop revolutionary new drugs.

1. Background

The number of patients within Japan suffering from Alzheimer’s disease and other forms of dementia is expected to rise along with the aging of the Japanese society and reach 3.25 million by the year 2020 (Source: “Everyone’s Mental Health” of the Ministry of Health, Labor and Welfare). About half of patients with dementia suffer from Alzheimer’s disease, and the burden upon their families and society is heavy. Consequently, the conquering of Alzheimer’s disease at an early stage is an important issue for Japan as a medically advanced country. However at the current time there are no fundamental treatments or preventative measures that have been established, and there are only symptomatic treatments. In order to establish fundamental treatments, it is critical to fully understand the pathogenic mechanisms of the disease and to translate the findings on important mechanisms into discovery of novel drugs for the disease.

Laboratory for Proteolytic Neuroscience at the RIKEN BSI conducts research designed to acquire fundamental knowledge for mechanisms of proteolysis responsible for pathological cascade in neurodegenerative diseases that can be used in the diagnosis, prevention, and treatment of patients with neurodegenerative disorders. In particular, the top priority given to Alzheimer’s disease has led to the acquisition of new information on the important causative agent (amyloid beta peptide) in July 2011... [PDF] Astellas Pharma's Press Release - RIKEN's Press Release -

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 -