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Wednesday, December 21, 2011

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

Neoprobe
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.

AstraZeneca

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 -

Wednesday, December 7, 2011

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

Dainippon Sumitomo Pharma
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 -

Monday, November 21, 2011

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

Probiodrug AG
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 -

Tuesday, November 8, 2011

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 -

Wednesday, October 19, 2011

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

Transition Therapeutics
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 -

Thursday, October 6, 2011

Brainsway : Positive Interim Results in Alzheimer's Trial

Brainsway
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 -

Thursday, September 29, 2011

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

Madera Biosciences
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 -

Tuesday, September 20, 2011

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

Bristol-Myers Squibb
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.

Ortho-Clinical Diagnostics

“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.”

Saladax Biomedical

"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 -

Tuesday, September 13, 2011

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

Hawthorn PharmaceuticalsSeptember 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 -

Wednesday, September 7, 2011

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).
 
Evotec

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.

Roche

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 -

Tuesday, August 30, 2011

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

AMRIAugust 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 -

Monday, August 22, 2011

Rexahn Pharmaceuticals : European Patent granted for Neurotherapeutic Compositions

Rexahn PharmaceuticalsAugust 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 -

Tuesday, August 2, 2011

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

Charles River LaboratoriesJuly 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 -

Wednesday, July 20, 2011

Orasi Medical : Clinical Results on Alzheimer's Disease Severity

Orasi MedicalJuly 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 -

Wednesday, July 13, 2011

EnVivo : Initiation of Gamma Secretase Modulator Clinical Program in Alzheimer’s Disease

EnVivo PharmaceuticalsJune 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 -

Wednesday, July 6, 2011

Osta Biotechnologies : PROMISING RESULTS ON NEW EXPERIMENTAL DRUG FOR ALZHEIMER’S DISEASE

Osta BiotechnologiesApril 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 -

Thursday, June 30, 2011

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

Yuma TherapeuticsMarch 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 -

Friday, June 24, 2011

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

AxxamJune, 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 -

Tuesday, June 21, 2011

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

Clarimedix 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 -

Tuesday, June 14, 2011

Mylan : Approval for Generic Version of Aricept® Tablets

 Matrix Laboratories LimitedJune 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.

mylan

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 -

Tuesday, May 31, 2011

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

Prana BiotechnologyApril 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 -

Tuesday, May 17, 2011

AB Science : Masitinib as an Adjunct Therapy for Alzheimer’s Disease

AB Science19 April 2011 - Publication in Alzheimer’s Research and Therapy - AB Science SA (NYSE Euronext - FR0010557264 - AB), a pharmaceutical company specializing in the research, development and commercialization of protein kinase inhibitors (PKIs), announces the publication of results from the first human phase 2 study of masitinib carried-out in the treatment of Alzheimer’s disease. Entitled, ‘Masitinib as an adjunct therapy for mild-to-moderate Alzheimer’s disease: a randomised, placebo-controlled phase 2 trial’, this article is freely accessible online from BioMed Central's peer-reviewed journal Alzheimer’s Research and Therapy .
  • Phase 2 study establishes proof-of-concept that oral masitinib has potential therapeutic benefits in patients with mild-to-moderate Alzheimer’s disease
  • Overall, results add new scientific data to the important question of the potential role of anti inflammatory agents in the management of Alzheimer’s disease
  • AB Science is actively preparing to launch a phase 3 study, pivotal in the process of registration of masitinib in this indication
This randomized placebo-controlled phase 2 trial, conducted by Professor François Piette (Hôpital Charles Foix in Ivry-sur-Seine) and colleagues from 12 study centers across France, investigated the hypothesis that masitinib’s targeted inhibitory action on mast cells may reduce the symptoms of Alzheimer’s disease. A total of 35 patients were included in this study. Neuroinflammation is thought to be important in Alzheimer’s disease pathogenesis. Mast cells are a key component of the inflammatory network and participate in the regulation of the blood-brain barrier’s permeability. Masitinib, a selective oral tyrosine kinase inhibitor, effectively inhibits the survival, migration and activity of mast cells... [PDF] AB Science's Press Release -

Thursday, May 5, 2011

StemCells, Inc. Advances Alzheimer's Disease Program Through Collaboration With Leading Researcher

StemCellsApr 18, 2011 - StemCells, Inc. (Nasdaq:STEM) announced that it has entered into a collaboration with Frank LaFerla, Ph.D., a world renowned leader in Alzheimer's disease research, to study the therapeutic potential of the Company's HuCNS-SC(R) human neural stem cells in Alzheimer's disease. Dr. LaFerla's published research has shown that mouse neural stem cells enhance memory in a mouse model of Alzheimer's disease. The goal of this collaboration is to replicate these results using the Company's human neural stem cells.

"This collaboration is a natural evolution of Dr. LaFerla's pioneering research, and will build on the promising results we have seen to date in other preclinical studies of our cells in Alzheimer's disease," said Stephen Huhn, MD, FACS, FAAP, Vice President and Head of the CNS Program at StemCells, Inc. "Our growing human clinical database already includes a favorable safety profile in fatal neurodegenerative disorders as well as proof of engraftment of our HuCNS-SC cells in the brain. Consequently, we will be well positioned for rapid advancement into clinical testing in Alzheimer's disease following successful results from this research collaboration."... StemCells' Press Release -

Monday, April 18, 2011

Quanterix Discovers Link Between Heart Attack–induced Hypoxia and Suspected Alzheimer’s Disease Pathway

QuanterixApril 12, 2011 - Single Molecule Technology First to Detect Increase in Alzheimer’s Disease Plaque Peptide Following Cardiac Arrest Quanterix Corporation, enabling a new generation of diagnostics based on revolutionary Single Molecule Array (SiMoA™) technology, announced that significant elevations in blood levels of amyloid beta (Aβ) 42 peptide, a component of the plaques that are a hallmark of Alzheimer’s disease, were detected in patients who experienced hypoxia (inadequate supply of oxygen to the brain) following cardiac arrest. The ability of SiMoA to measure extremely low abundance proteins has enabled discovery of a direct link between brain injury caused by hypoxia and increased Aβ42 levels in blood. Results were presented on April 12 at the American Academy of Neurology Annual Meeting April 9–16 in Honolulu, Hawaii.

The Aβ42 testing was conducted at Quanterix on serum samples obtained from 26 resuscitated patients who were admitted to the Department of Surgical Sciences, Anaesthesia and Intensive Care, Uppsala University, Uppsala, Sweden. In the study, all 26 patients exhibited a significant elevation of Aβ42 ranging from approximately 50% to over 30–fold. "These data are the first to show a correlation between hypoxic stress and the upregulation of Aβ42 in humans. The findings also indicate that Aβ42 levels after cardiac arrest correlate with long term cognitive outcome. The study highlights the potential of SiMoA to illuminate disease pathways involving proteins present at previously undetectable levels." said David Wilson, Ph.D., Senior Director, Product Development at Quanterix and lead author of the study... Quanterix's Press Release -

Monday, April 11, 2011

Revalesio : Alzheimer’s Disease Research at National Neurology Conference

Revalesio CorporationApril 4, 2011 - Revalesio Corporation, a pioneering biotechnology company, and Rush University will present research on the use of RNS60 in Multiple Sclerosis and Alzheimer’s disease at the American Academy of Neurology (AAN) meeting April 9-16 in Honolulu, Hawaii.
“The data we’re presenting at AAN supports our work in establishing RNS60 as a strong therapeutic candidate across multiple inflammatory diseases,” said Richard Watson, M.D., Director of Clinical Research at Revalesio. “These findings, combined with the research recently presented at the American Society for Neurochemistry and American Academy of Asthma Allergy and Immunology, create a strong foundation for our development of novel CSN-based therapeutics to improve the outcomes of patients with inflammatory diseases. Combined with the excellent safety profile of RNS60 to date, the findings make a strong case for testing RNS60 in clinical trials,” said Dr. Watson.
Revalesio will present data at the national conference from studies in multiple preclinical models of Multiple Sclerosis that demonstrated a significant reduction in disease scores related to the use of RNS60. These results identify the strong potential of RNS60 as a low-risk therapeutic for treating Multiple Sclerosis.
Revalesio will also present data related to Alzheimer’s disease. In a well-established cell culture model of the disease, RNS60 dose-dependently inhibited the activation of a protein called Tau. Tau activation is a known cause behind the generation of neurofilament tangles often found in the brains of Alzheimer’s patients and is widely considered to be a contributor to the symptoms of Alzheimer’s disease. RNS60 also protected neurons challenged with beta-amyloid from apoptosis (cell death)... Revalesio's Press Release -

Tuesday, April 5, 2011

Aurobindo Pharma : USFDA approval for Galantamine Tablets

Aurobindo Pharma Limited30th March 2011 - Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Galantamine Tablets USP 4mg, 8mg and 12mg

Galantamine Tablets USP 4mg, 8mg and 12mg is the generic version of Ortho McNeil Janssen Pharmaceutical, Inc's Razadyne® Tablets 4mg, 8mg and 12mg. The product falls under the neurological (CNS) therapeutic category and is indicated for the treatment of mild to moderate dementia of the Alzheimer's type. The product has a market size of approximately US$ 41 million for the twelve months ending September 2010 according to IMS and will be launched shortly... Aurobindo Pharma's Press Release -

Tuesday, March 29, 2011

Pico-Tesla : Alzheimer’s disease Study with University of South Florida (USF) Health Byrd Alzheimer’s Institute

Pico-Tesla, The Magneceutical® CompanyJan. 5, 2011 - Pico-Tesla starts pilot study of Magneceutical® Therapy for Alzheimer’s disease at University of South Florida (USF) Health Byrd Alzheimer’s InstitutePico-Tesla, The Magneceutical® Company, announced that it has commenced a randomized, double-blind, placebo-controlled pilot study of 30 patients who have Alzheimer’s disease symptoms. The pilot study seeks to determine whether the application of magnetic fields generated by Pico-Tesla’s patented Resonator™ system can be effective as an adjunctive therapy to oral medications in reducing the symptoms of Alzheimer’s disease.

The study will be coordinated by Amanda Grant Smith, M.D., Medical Director of the USF Health Byrd Alzheimer’s Institute, University of South Florida (USF).

“We are very pleased to have Dr. Amanda Smith coordinating this important study that may help to explore the clinical potential of Magneceutical® Therapy for Alzheimer’s patients,” said Allen Braswell, CEO of Pico-Tesla.

Dr. Smith received her undergraduate degree from Emory University in 1992 and her medical degree from Jefferson Medical College in 1997. She did her internship, residency in psychiatry, and fellowship in geriatric psychiatry at the University of South Florida College of Medicine. Dr.
Smith is a Diplomate of the American Board of Psychiatry and Neurology, with subspecialty certification in geriatric psychiatry. She is a member of the American Association for Geriatric Psychiatry and a charter member of ISTAART, the International Society to Advance Alzheimer Research and Treatment... Pico-Tesla's Press Release -

Wednesday, March 23, 2011

BiOxyDyn Anatomical Connectivity Mapping (ACM) approach shows sensitivity to Alzheimer's disease

BiOxyDynOctober 2010 - BiOxyDyn Anatomical Connectivity Mapping (ACM) approach shows sensitivity to Alzheimer's disease - Anatomical connectivity mapping, or ACM, is a technique that uses magnetic resonance imaging (MRI) to detect subtle alterations in the 'wiring pattern' of the brain that can occur in a range of diseases. Recent work performed by Dr Marco Bozzali and colleagues at the Santa Lucia Foundation, Rome, in conjunction with researcher from the University of Manchester, shows that ACM is more sensitive to some of subtle the effects of Alzheimer's on the brain than more established MRI measurements. Importantly, Dr Bozzali's team also show that ACM measurements are related to the severity of patient's memory impairment with Alzheimer's disease. BiOxyDyn's Press Releases -

Tuesday, March 15, 2011

NeuroPhage Pharmaceuticals : $12.4M Series B round

NeuroPhage PharmaceuticalsMarch 1, 2011 - NeuroPhage Pharmaceuticals, Inc. (NeuroPhage), a privately held biotechnology company developing a protein disaggregation platform for treatment of neurodegenerative diseases, announced that it has secured $12.4 million in Series B financing, which will be mostly directed to the IND-enabling activities in preparation of a Phase 1 clinical trial for NPT001, NeuroPhage’s lead product candidate for the treatment of Alzheimer’s disease, and include further work to expand the platform.

Shire LLC
The round was led by Mérieux Développement and also included Shire LLC as a new investor. Existing investors reiterated their strong support in this Series B round, bringing the total amount of equity capital raised by NeuroPhage to $19.6 million since its inception in 2007... NeuroPhage Pharmaceuticals' Press Release -

Mérieux Développement

Wednesday, March 9, 2011

Curaxis Pharmaceutical : CEO Patrick S. Smith Comments on Recent Alzheimer's Association

Curaxis Pharmaceutical Corp.Feb. 7, 2011 -- Patrick S. Smith, President and Chief Executive Officer of Curaxis Pharmaceutical Corp. (OTCBB:CURX), commented on a new report by the Alzheimer's Association, titled "Generation Alzheimer's – the defining disease of the baby boomers", which demonstrates the devastating impact and size of Alzheimer's disease. Five million Americans have already been diagnosed with Alzheimer's, and that number may increase as the Baby Boomer generation turns 65 this year, according to the report.
Mr. Smith stated, "With 10 million baby boomers expected to either die with or from Alzheimer's, it is certainly time for Curaxis to take its place in providing a solution for this debilitating disease. We are looking to complete our evaluation of potential candidates and engage a Contract Research Organization for Curaxis' upcoming Phase IIB clinical trial in the near term. From a cost competitive standpoint, as well as the high demand for Alzheimer's clinical work, our market timing for the selection of a CRO could not be better."
The phase IIB clinical trial for Curaxis' lead Alzheimer's disease treatment, Memryte, is anticipated to launch in mid 2011. Memryte addresses the pathologies of Alzheimer's through multiple pathways, including beta-amyloid, tau phosphorylation, inflammation and aberrant cell cycling... Curaxis Pharmaceutical's Press Release -

Tuesday, March 1, 2011

Repligen Licenses Rights to Use of HDAC3 Inhibitors for Memory Disorders

RepligenJanuary 20, 2011 - Study Published in The Journal of NeuroscienceRepligen Corporation (NASDAQ: RGEN) announced that it has entered into an exclusive license agreement with the University of California, Irvine (UCI) for a patent application covering the use of histone deacetylase 3 (HDAC3) inhibitors for the treatment of disorders involving preservation or extinction of memory including Alzheimer’s disease, memory impairment and post traumatic stress disorder. The patent application is based on work conducted at UCI by Dr. Marcelo A. Wood, which demonstrated that one of Repligen’s HDAC3 inhibitors improved both the acquisition and persistence of long-term memory in an animal model. These data were published in the January 12th issue of The Journal of Neuroscience in a manuscript entitled “HDAC3 Is a Critical Negative Regulator of Long-Term Memory Formation” (McQuown, S., et al., J. Neurosci. (2011) 31:764 –774). Under the terms of the license agreement, UCI will receive an upfront payment, development milestones and royalties upon successful commercialization of an HDAC3 inhibitor for certain memory disorders. Upon issue, the patent will remain in force until 2031 prior to any regulatory extensions... [PDF] Repligen's Press Release -