Alzheimer

Medivation and Pfizer : Results from Phase 3 Concert Trial of Dimebon in Alzheimer's Disease

2012-02-07T15:12:00.000-08:00

January 17, 2012 - Dimebon Did Not Meet Primary Efficacy Endpoints - Medivation, Inc. (NASDAQ: MDVN) and Pfizer Inc. (NYSE: PFE) announced results from the CONCERT trial, which is a Phase 3 trial that evaluated dimebon (latrepirdine) when added to ongoing treatment with donepezil HCL tablets in patients with mild-to-moderate Alzheimer's disease. Dimebon did not achieve statistically significant results for either of the two co-primary endpoints, the Alzheimer's Disease Assessment Scale — cognitive subscale (ADAS-cog), which measures cognitive ability, or the Alzheimer's Disease Cooperative Study — Activities of Daily Living (ADCS-ADL), which measures self care and daily function.

"We are disappointed in the CONCERT results and the implications for Alzheimer's disease patients and their caregivers," said David Hung, M.D., president and CEO of Medivation. "I would like to extend my sincere thanks to the patients, their physicians and study teams involved in this trial."

Dimebon was generally well tolerated in the study. A full analysis of the results from CONCERT will be conducted and submitted for presentation at an upcoming scientific congress.

Medivation and Pfizer will discontinue development of dimebon for all indications and will terminate the ongoing open label extension study in Alzheimer's disease. The companies also announce that they will terminate their collaboration to co-develop and market dimebon pursuant to the terms of their Collaboration Agreement... Medivation's Press Release - Pfizer's Press Release -

Aphios® Awarded Phase II SBIR Grant From National Institute On Aging For Alzheimer's Disease Research

2012-01-26T15:43:00.000-08:00

January 24, 2012— Aphios® Corporation has received a Phase II SBIR grant from the National Institutes of Health (NIH) amounting to $2.4 million over two years. The National Institute on Aging (NIA), part of the NIH, awarded the grant to the Aphios Corporation to develop an “Alzheimer’s Disease Therapeutic.”

Alzheimer’s Disease (AD) is the third leading cause of death in America and among the highest in the industrial world. AD is a devastating age-related neurological disorder that affects more than 4.5 million Americans and more than 10 million people worldwide. Experts estimate that 22 million people around the world and more than 8 million Americans will be afflicted with this disease by 2025.

“Aphios is developing APH-0703, a potent protein kinase C (PKC) modulator that activates the alpha-secretase pathway which can dramatically enhance the generation of soluble amyloid precursor protein (sAPP), diminishing plaques and cognitive deficits associated with Alzheimer’s Disease,” explains Dr. Trevor P. Castor, President and CEO, Aphios Corporation. “We are developing novel formulations of APH-0703 based on Aphios’ proprietary hydrophobic-based formulation and patented SFS-PNS polymer nanospheres technologies. After formulation selection, Aphios will manufacture and characterize the API and final drug product following cGMP guidelines, and conduct preclinical studies in preparation of filing an IND with the FDA to conduct human clinical trials.”... Aphios' Press Release -

Targacept : Decision by AstraZeneca to Advance AZD1446 in Alzheimer’s Disease

2012-01-18T09:46:00.000-08:00

January 05, 2012 - Targacept, Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing novel NNR Therapeutics™, announced that AstraZeneca has informed the company that it plans to progress the development of Targacept’s product candidate AZD1446 as a treatment for Alzheimer’s disease.

AZD1446 is a selective modulator of the alpha4beta2 neuronal nicotinic receptor that arose out of a research collaboration conducted by Targacept and AstraZeneca. Under the terms of a 2005 collaborative research and license agreement, AstraZeneca is responsible for conducting and funding the development and potential commercialization of AZD1446. The next clinical trial of AZD1446 is expected to be a Phase 2 study as an adjunct treatment to donepezil in patients with mild to moderate Alzheimer’s disease... Targacept's Press Release -

Abbott Biotech Ventures Invests in NeuroGenetic Pharmaceuticals

2012-01-10T16:22:00.000-08:00

January 4, 2012 - Advancing Research on Therapy for Alzheimer’s Disease -

NeuroGenetic Pharmaceuticals, Inc. (NGP), a privately held biopharmaceutical company focused on Alzheimer’s disease (AD) therapeutics, has received an investment from Abbott Biotech Ventures. The amount of the investment was not disclosed. Dr. William T. Comer, president and CEO of NGP said, “The funding will expedite the development of our lead candidate, NGP 555, for the prevention of AD, including achieving our immediate goal of initiating clinical trials.”

Earlier, NGP announced that it has been awarded a Small Business Innovation Research (SBIR) fast-track grant from the National Institutes of Health (NIH) for preclinical work on NGP 555. The first phase award is in the amount of $288,000 with future awards to approach $1 million for each subsequent phase, which can be up to three rounds of additional funding for milestone-based achievements.

About NeuroGenetic Pharmaceuticals, Inc.

NeuroGenetic Pharmaceuticals, Inc. (NGP), a biopharmaceutical discovery and development company founded in 2009, is developing innovative drug therapies for Alzheimer’s disease. Based in San Diego, Calif., the company’s next objective is to obtain an Investigational New Drug approval for its clinical candidate, NGP 555. Future clinical trials will utilize specific amyloid biomarkers and/or brain scanning as an early diagnostic and to monitor drug efficacy in clinical trials. Combining early disease identification with a treatment capable of preventing AD-related pathology, such as NGP 555, would represent an important advance in our ability to prevent AD or hinder its progression to dementia. Clearly, the earlier AD is detected and treated, the better the likelihood of a good outcome.

NGP 555, a proprietary “first in class” molecule for the treatment/prevention of Alzheimer’s disease, is a gamma-secretase modulator targeting the γ-secretase complex, a key enzyme in the amyloid pathway. The compound has excellent brain penetration and is devoid of side-effects seen with other potential amyloid therapies such as gamma-secretase inhibitors and monoclonal antibodies. Based on the pre-clinical studies in rodents, this compound is expected to prevent the formation of Aβ42 and the deposition of amyloid plaques in the human brain, thereby precluding neuronal cell death and the dementia associated with AD... NeuroGenetic Pharmaceuticals' Press Release -

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

2011-12-21T10:41:00.000-08:00

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”

2011-12-07T09:24:00.001-08:00

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

2011-11-21T11:21:00.001-08:00

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

2011-11-08T14:58:00.000-08:00

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

2011-10-19T14:15:00.000-07:00

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

2011-10-06T11:29:00.000-07:00

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

2011-09-29T13:44:00.000-07:00

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

2011-09-20T17:14:00.000-07:00

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

2011-09-13T14:44:00.000-07:00

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

2011-09-07T14:10:00.000-07:00

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

2011-08-30T15:44:00.000-07:00

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

2011-08-22T14:53:00.000-07:00

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

2011-08-02T13:11:00.000-07:00

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

2011-07-20T14:01:00.000-07:00

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

2011-07-13T14:55:00.000-07:00

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

2011-07-06T14:41:00.000-07:00

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

2011-06-30T14:52:00.000-07:00

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

2011-06-24T14:03:00.000-07:00

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

2011-06-21T14:22:00.000-07:00

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

2011-06-14T15:25:00.000-07:00

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 -

Prana Biotechnology secures key PBT2 patent in Japan and completes core IP suite

2011-05-31T14:17:00.000-07:00

April 11th, 2011 - Patents support pipeline opportunities for PBT2 in AD and HD - Prana Biotechnology (ASX: PBT; NASDAQ: PRAN) announced that it has secured a key PBT2 patent in Japan. The Japanese Patent Office has granted a composition of matter patent for Prana’slead clinical asset, PBT2 and other selected 8-Hydroxyquinoline compounds in Japan. The patent entitled ‘8-Hydroxyquinoline derivatives’ also covers pharmaceutical compositions containing PBT2 and selected 8-hydroxyquinoline compounds and the use of the compounds for the treatment of Alzheimer’s Disease.
Geoffrey Kempler, Prana’s Executive Chairman, said “This decision by the Japanese Officeto grant a claim to PBT2 completes a suite of core patent rights protecting this asset in key markets including the United States, Europe, Japan and Australia, further bolstering our commercialization plans in both Huntington’s and Alzheimer’s Disease”.
The Japanese patent has a twenty year term expiring on 16 July 2023, with a possible extension of term of up to 5 years under pharmaceutical protectionprovisions. Importantly there is no post-grant opposition process in Japan whereby third parties can register objections following this decision. In 2010, the company announced the grant of similar claims in Europe and the decision of the United States Patent Office to extend the term of the patent granted in the United States**.
PBT2 was selected from Prana’s Metal Protein Attenuating Compound (MPAC) library as its lead development compound in Alzheimer’s Disease in 2004... [PDF] Prana’s Press Release -