Nanotherapeutics Acquires Late Stage Clinical Program for Alzheimer's Treatment

December 16, 2009 - Nanotherapeutics, Inc., a privately held biopharmaceutical company, announced that it has acquired in bankruptcy proceedings two late stage clinical programs: Ramoplanin from Oscient Pharmaceuticals Corporation and PRX-3140 from EPIX Pharmaceuticals, Inc. Ramoplanin - an oral antibiotic for the treatment of Clostridium difficileassociated disease (CDAD) - is entering Phase 3 trials. PRX-3140 - an orally-bioavailable Alzheimer’s treatment - is in Phase 2 clinical studies. Nanotherapeutics also acquired the U.S. and foreign patent estates covering each clinical program... [PDF] Nanotherapeutics' Press Release -

Proteostasis Therapeutics: Paper in Cell Establishing Role of the Proteostasis Network in Alzheimer's Disease

December 15, 2009 - Proteostasis Therapeutics announced that modulating a key Proteostasis Network (PN) pathway may offer a novel approach to Alzheimer’s disease, a finding that was published in the journal Cell by its scientific founders Andrew Dillin, Ph.D., and Jeffery Kelly, Ph.D. The publication describes how regulation of an aggregase pathway reduced the neurodegenerative effects of beta amyloid aggregates that are a hallmark of the disease. Proteostasis has exclusively licensed the intellectual property for modulating this pathway from the Salk Institute and is integrating it into its proprietary technology platform directed to the discovery of a new class of therapeutics, Proteostasis Regulators (PR), small molecules designed to correct defects in the PN... Proteostasis Therapeutics' Press Release -

Neurotez : "Testing a Leptin product as a novel therapy for Alzheimer's disease"

Oct. 14 2009 - Neurotez : Dr. J. Wesson Ashford, MD, PhD (Clinical Professor at Stanford University and a Senior Scientist at the Palo Alto VA) will be presenting at the the CTAD (Clinical Trials in Alzheimer's disease) meeting in Las Vegas on Oct 30th, 2009. The title of his talk is: "Testing a Leptin product as a novel therapy for Alzheimer's disease". Neurotez's news -

SRI Roche : Translational Medicine Collaboration to Study Methods and Treatments Associated with Cognitive Deficits across Neuropsychiatric Disorders

November 10, 2009 — SRI International, an independent nonprofit research and development organization, announced that its Center for Neuroscience has entered into a research collaboration with F. Hoffmann-La Roche to study procedures and treatments for cognition impairments in neurological and psychiatric conditions such as Alzheimer's disease, depression and schizophrenia.
Research will take place in SRI's laboratories in Menlo Park, California... SRI International's press release -

Grifols : interim results of its clinical trial on Alzheimer’s disease

9/22/2009 - The preliminary results of the trial suggest that patients who received treatment showed a trend towards stabilization of the disease

The line of investigation was based on the systematic practice of therapeutic plasmapheresis with Human Albumin Grifols in patients with this disease

Back in 2005, the Clinical Research Department at Grifols designed a clinical study to explore whether the use of successive plasmapheresis with human albumin in patients with Alzheimer’s disease could mobilize the beta amyloid protein implicated in the disease from the cerebrospinal fluid into the blood. Dr. Boada, Medical Director of the Fundació ACE and Clinician Head at the Neurology Service at the Vall d’Hebron Hospital, Barcelona, agreed to conduct this preliminary study, and the positive results with respect to the cognitive status of the patients treated gave rise to the design and development of a clinical trial with the participation of three hospitals in Spain and two in the United States.

The interim results of this trial, recently published in the journal Drug News and Perspectives (DOI: 10.1358/dnp.2009.22.6.1395256) highlight both the improvement of cognitive status of patients treated and the evidence that amyloid beta is mobilized in the blood of patients who undergo therapeutic plasmapheresis with albumin. However, it is necessary to complete the clinical trial before the improved cognitive development can be confirmed... Grifols' Press Release -

Accera : Peer-Reviewed Publication of the Results of its 90-day Clinical Study of AC-1202 (Axona™) in Mild to Moderate Alzheimer’s Disease

August 12, 2009 – Accera, Inc., a biotechnology company delivering breakthrough therapies in central nervous system (CNS) disorders, announced publication of a scientific paper in the peer-reviewed journal Nutrition & Metabolism. The paper, entitled “Study of the ketogenic agent AC-1202 in mild to moderate Alzheimer’s disease: a randomized, double-blind, placebo-controlled, multicenter trial” suggests that daily administration of AC-1202 (Axona™) can help improve cognition and memory in patients with mild-to-moderate Alzheimer’s disease (AD)... Accera's Press Release -

Alzheimer's Drug Discovery Foundation Funds EDUNN Biotechnology to Develop Treatment for Alzheimer's Disease

January 15, 2009 - The Alzheimer's Drug Discovery Foundation (ADDF) announced that it is providing a grant of $100,000 to Edunn Biotechnology, Inc., an early stage company dedicated to developing a novel class of drugs to treat and prevent Alzheimer's disease (AD)

Edunn's lead drug candidate, EDN-OL1, is an oligonucleotide-based drug that has shown promise in halting and reversing the progression of AD in animal models. EDN-OLI reduces the production of amyloid beta proteins found in the brain and believed to cause AD... Edunn Biotechnology's Press Release -

Sanomune : Promising new treatment for Alzheimer’s disease licenced

March 4, 2009 – A Canadian bio-technology company, Sanomune Inc., has licensed a new treatment method that helps drugs to reach the brain unlike any other treatment for neurological diseases. The treatment method, developed by HealthPartners Research Foundation, is a new therapeutic technology offering hope to the 5.2 million people in the United States living with Alzheimer’s disease and other neurological diseases.

The intranasal method was developed by William H. Frey II, Ph.D., senior director of HealthPartners Research Foundation’s Alzheimer’s Research Center, and his colleagues. It allows medication to bypass the protective blood-brain barrier and enter the brain directly. Dr. Frey developed a way to bypass the barrier for neurological conditions using intranasal delivery of Deferoximine or SAN-121. SAN-121 has previously been shown when given in twice daily injections to reduce cognitive decline in Alzheimer’s patients by 50 percent. However, systemic delivery has unwanted and negative side effects including a drop in blood pressure. With intranasal delivery, side effects can be significantly reduced... Sanomune's Press Release -

Avineuro : positive Phase I clinical trial results on AVN-101, potent small molecule for treatment of Alzheimer’s disease.

October 26th, 2009 – Avineuro Pharmaceuticals, Inc. reported clinical Phase I results on AVN-101, a potent small molecule for treatment of Alzheimer’s disease. AVN-101 was well tolerated in a wide range of doses and no adverse events were observed. Avineuro Pharmaceuticals, Inc. plans to start Phase II clinical trials with AVN-101 in Alzheimer’s disease in Q1 2010... Avineuro Pharmaceuticals' Press Release -

Mithridion : Phase I Study Results in Alzheimer’s Disease

April 7, 2009 -- Mithridion, Inc., a biopharmaceutical company focusing on serious central nervous system (CNS) disorders, announced results from a Phase I pharmacokinetic and clinical study of MCD-386, its lead drug candidate for Alzheimer’s disease (AD). MCD-386 is an M1 selective muscarinic agonist with “first-in-class” potential for improving memory and cognition symptoms, and for disease-modifying effects (or stopping disease progression) in AD...

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...Mithridion is developing a controlled release formulation with the dual objectives of extending the duration of action and avoiding elevated peak (Cmax) concentrations, while maintaining the MCD-386 concentration above the therapeutic level. The company plans to evaluate the safety, tolerability and pharmacokinetics of MCD-386 in a randomized, double-blind, placebo-controlled, ascending multiple-dose Phase I study to commence in the fourth quarter of 2009... [PDF] Mithridion's Press Release -

Critical Outcome Technologies: Launch of a Drug Discovery Program for Alzheimer's Disease

July 21, 2009 : Critical Outcome Technologies Inc. (COTI) , announced that the Company has undertaken the discovery and optimization of novel lead compounds for the treatment of Alzheimer’s Disease (AD). “Based on partnering interest expressed by multiple global pharmaceutical organizations we have decided to establish a drug discovery program to help combat this devastating disease”, said Mr. Michael Cloutier, Chief Executive Officer of COTI.
To address this substantial unmet medical need, COTI has leveraged its proprietary drug discovery technology CHEMSAS® to develop a novel approach for the discovery of potentially effective oral treatments for AD. Multiple and interacting factors have been proposed as causes of AD and there is an increasing number of validated therapeutic targets. Traditional drug development has focused on agents that inhibit an enzyme of the neural transmitter Acetylcholine. The United States Food and Drug Administration (FDA) and European Medicines Agency have approved treatments for AD from this class that currently dominate the market although they have not produced results that consistently meet the requirements of healthcare professionals and patients. The COTI scientific team has focused their research efforts on the area of secretases, a class of enzymes that cut the amyloid precursor protein into three fragments. Sequential cutting by beta secretase and gamma secretase produces the beta amyloid peptide fragments that accumulate into the "plaques" or scars found in the brains of people with AD... [PDF] Critical Outcome Technologies' Press Release -

Ichor Awarded $3.3 Million NIH Grant to Develop Alzheimer's Disease Vaccine

August 5, 2009 - Ichor Medical Systems (Ichor) of San Diego announced that it has been selected to receive a $3.3 million grant award from the National Institute of Neurological Disorders and Stroke (NINDS) for development of a vaccine for Alzheimer’s disease. Ichor is collaborating on the project with Dr. Michael Agadjanyan, Vice President and Head of Immunology at the Institute for Molecular Medicine (IMM), Huntington Beach, CA; Dr. David H. Cribbs, Professor, Department of Neurology and Institute for Memory Impairments and Neurological Disorders at the University of California, Irvine (UCI); and Dr. Ruth Mulnard, Associate Professor of Neurology and Associate Director, Institute for Clinical Translational Science at UCI.
In the last few years the laboratories of Dr. Agadjanyan and Dr. Cribbs have designed and evaluated DNA-based vaccines for Alzheimer’s disease. In mice genetically engineered to model Alzheimer's disease, these vaccines slowed the development of pathology and reduced behavioral deficits. Building upon these promising research findings, Ichor will evaluate its proprietary TriGrid™ electroporation technology for delivery of DNA vaccines encoding proteins implicated in the development of Alzheimer’s disease.
The objective of this approach is to induce antibody responses that slow down progression of Alzheimer’s disease, or if vaccination is initiated early enough, could even prevent disease development. The plan funded by the NINDS includes the studies required to support eventual initiation of human clinical testing of this approach... [PDF] Ichor Medical Systems' Press Release -

Humanetics : Findings at 2009 Alzheimer’s Association International Conference

July 13, 2009— The results of a preliminary clinical trial suggest that a new Alzheimer’s drug from Humanetics Corporation is safe for daily use and that cognitive performance in patients with mild to moderate disease remained stable during the six-week course of the trial. The lack of decline in cognitive performance was an encouraging finding to be further evaluated in a Phase IIB clinical trial. Phase IIA clinical findings were presented in Vienna at the 2009 Alzheimer’s Association International Conference on Alzheimer’s Disease (ICAD 2009) by investigators from The Mount Sinai School of Medicine (MSSM). The study was conducted at The Mount Sinai Alzheimer’s Disease Research Center in New York, a nationally renowned center of excellence since 1984 offering a comprehensive clinical program and research facility dedicated to the study and treatment of both normal aging and Alzheimer’s disease.
Study investigators Giulio Pasinetti, M.D., Ph.D. and Hillel Grossman, M.D., both of Mount Sinai School of Medicine, each made a poster presentation on NIC5-15 at ICAD 2009. Dr. Pasinetti said his findings supported the conclusion that “NIC5-15 is a safe and tolerable natural compound that may alleviate Alzheimer’s disease dementia through multiple mechanisms including Abeta lowering activities. These early findings suggest the need for further investigation of NIC5-15 in the treatment of Alzheimer’s disease.”... Humanetics' Press Release -

Boehringer Ingelheim and Vitae Pharmaceuticals : a major collaboration to research and develop novel treatments for Alzheimer`s disease

15 June 2009 - Boehringer Ingelheim and Vitae Pharmaceuticals, Inc., announced that they have entered into a significant worldwide collaboration to research and develop beta-secretase (BACE) inhibitors for the treatment of Alzheimer’s disease. Current therapies for Alzheimer’s disease can improve symptoms, but do not affect the progression of the disease. The inhibition of BACE - an enzyme involved in the formation of amyloid-beta plaques which accumulate in the brains of patients with Alzheimer’s disease - offers the potential to slow or even halt disease progression.

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Vitae Pharmaceuticals
Vitae Pharmaceuticals is an emerging pharmaceutical company building a clinical stage pipeline of novel drug candidates in important therapeutic categories, such as cardiovascular disease, diabetes and Alzheimer’s disease...

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Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 138 affiliates in 47 countries and 41,300 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine... Boehringer Ingelheim's Press Release - [PDF] Vitae Pharmaceuticals' Press Release -

Adeona Pharmaceuticals : Results of Clinical Study at 2009 International Conference on Alzheimer’s Disease (ICAD)

July 16, 2009 - Highly Statistically Significant Defective Serum Copper Handling Found in Alzheimer’s Subjects - Subclinical Zinc Deficiency in Alzheimer’s Subjects Found - HartLab Introduced to International Alzheimer’s Community - Adeona Pharmaceuticals, Inc. (AMEX:AEN), a specialty pharmaceutical company dedicated to the awareness, diagnosis, prevention and treatment of zinc deficiency and chronic copper toxicity in the mature population, announced that it presented results of a 90 subject prospective, blinded, observational clinical study to evaluate copper and zinc status in Alzheimer’s disease, Parkinson ’s disease and normal subjects. The results were presented at the 2009 International Conference on Alzheimer’s Disease (ICAD) in Vienna, Austria. Two separate sets of study results were presented, entitled respectively, “Alzheimer’s Patients Exhibit Defective Serum Ceruloplasmin Associated with Defective Copper Binding” and “Sub-Clinical Zinc Deficiency Found in Alzheimer’s Disease.”...

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About Adeona Pharmaceuticals, Inc.

Adeona Pharmaceuticals, Inc. (AMEX:AEN - News) is a specialty pharmaceutical company dedicated to the awareness, diagnosis, prevention and treatment of subclinical zinc deficiency and chronic copper toxicity in the mature population. Adeona believes that such conditions may contribute to the progression of debilitating degenerative diseases, including, Dry Age-Related Macular Degeneration (Dry AMD), Alzheimer's disease (AD) and mild cognitive impairment (MCI) in susceptible persons. Adeona is also developing a number of late-stage clinical drug candidates for the treatment of rheumatoid arthritis and multiple sclerosis... Adeona Pharmaceuticals' Press Release -

Bayer Schering Pharma : positive Phase II data with florbetaben

July 13, 2009 - Potential to visualize beta-Amyloid plaques in Patients with Alzheimer’s disease demonstrated / Florbetaben may innovate the diagnostic capabilities – Bayer Schering Pharma AG, Germany, has presented positive data on a global Phase II study with the novel positron emission tomography (PET) tracer florbetaben (BAY 94-9172) at the International Conference on Alzheimer's Disease (ICAD) in Vienna, Austria. This study showed that patients with a clinical diagnosis of Alzheimer´s disease could be differentiated from age-matched healthy volunteers (HVs) on the basis of florbetaben uptake pattern in the brain.

Until now, the clinical diagnosis of Alzheimer´s disease (AD) with current methods such as cognitive tests is still limited. Currently, a definite diagnosis of Alzheimer´s disease is only possible post mortem. The results of this study showed PET images with a high specificity of over 90 percent: More than 90 percent of the HVs had a negative florbetaben scan (i.e. no tracer uptake) in the relevant brain regions. The results also show a sensitivity of approximately 80 percent indicated by the clinical diagnosis, meaning that about 80 percent of the clinically suspected Alzheimer patients had positive florbetaben scans indicating the presence of beta-Amyloid plaques. This is in line with the results of studies comparing the clinical diagnosis with the definite post mortem histopathological diagnosis...

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...Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life... Bayer Schering Pharma's Press Release -

Johnson & Johnson and Elan Corporation plc : Definitive Agreement for Alzheimer's Immunotherapy Program and Equity Investment

First-in-Class Alzheimer’s Treatments Expand Existing J&J Neuroscience Pipeline Johnson & Johnson Equity Investment Provides Financial Flexibility for Elan - July 2, 2009 – Johnson & Johnson (NYSE: JNJ) and Elan Corporation plc (NYSE: ELN) announced a definitive agreement whereby Johnson & Johnson will acquire substantially all of the assets and rights of Elan related to its Alzheimer’s Immunotherapy Program (AIP Program), through a newly formed company. In addition, Johnson & Johnson, through its affiliate, will invest $1 billion in Elan in exchange for newly issued American Depositary Receipts (ADRs) of Elan which will represent 18.4% of Elan’s outstanding ordinary shares.

The AIP Program represents Elan’s interest in a collaboration with Wyeth to research, develop and commercialize selective products for the treatment and/or prevention of neurodegenerative conditions, including Alzheimer’s disease.

Johnson & Johnson, through its affiliate, will assume and continue Elan’s activities with Wyeth under the AIP Program and will initially commit up to $500 million to continue the development and launch activities of bapineuzumab, a potential first-in-class treatment that is being evaluated for slowing the progression of Alzheimer’s disease, as well as other compounds. The agreement provides for additional funding obligations of the parties if needed...

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About Johnson & Johnson
Caring for the world, one person at a time….inspires and unites the people of Johnson & Johnson. We embrace research and science – bringing innovative ideas, products and services to advance the health and well-being of people. Our approximately 119,000 employees at more than 250 Johnson & Johnson companies work with partners in health care to touch the lives of over a billion people every day throughout the world.


About Elan
Elan Corporation, plc is a neuroscience-based biotechnology company committed to making a difference in the lives of patients and their families by bringing innovations in science to fill significant unmet medical needs. Elan shares trade on the New York, London and Dublin Stock Exchanges. The gross assets attributable to the AIP Program in the audited consolidated accounts of Elan as at 31 December, 2008 were US$63.1 million. Costs (losses) associated with the AIP Program in respect of the year ended 31 December, 2008 were approximately US$113 million... Elan's Press Release - Johnson & Johnson's Press Release -

BRNI and Inverness Medical Innovations to Develop Commercial Test to Detect Early Alzheimer’s Disease

May 27, 2009 – The Blanchette Rockefeller Neurosciences Institute (BRNI) and Inverness Medical Innovations, Inc. (Inverness, NYSE:IMA) of Waltham, Massachusetts, a global leader in rapid diagnostics and health management, announced that they will work together to further develop and commercialize a diagnostic test for Alzheimer’s disease first discovered by scientists at BRNI.

The BRNI test, once fully commercialized, could dramatically change the time and way that the disease is treated. The agreement also marks the first major global private sector deal involving BRNI technology and science. Under the terms of the arrangement, Inverness will fund the development efforts to be conducted by BRNI over an initial three year period. Inverness has also obtained an option which, if exercised, will provide Inverness with certain rights to the technology developed for use in the diagnosis, prognosis and monitoring of Alzheimer’s disease... Inverness Medical Innovations' Press Releases -

CeNeRx BioPharma : Novel Drug Candidate for Prevention and Treatment of Neurodegeneration Disorders

June 16, 2009 -- CeNeRx BioPharma, Inc., a clinical stage company developing and commercializing innovative treatments for diseases of the central nervous system (CNS), announced that it has obtained the rights to develop and market a novel agent for the prevention and treatment of neuropathies and neurodegenerative disorders. The drug candidate, CXB909, is a small molecule, orally active agent that enhances the effects of nerve growth factor (NGF). CeNeRx intends to initiate a Phase l trial of CXB909 for the treatment of chemotherapy-induced peripheral neuropathy (CIPN) later this year...
...CXB909 is a downstream enhancer of the effects of nerve growth factor, an endogenously produced neurotrophic factor that is important for the function and survival of several types of
neurons. Both Alzheimer’s disease and Huntington’s disease involve the degeneration of certain neurons, and neuronal damage is also implicated in the peripheral neuropathies associated with diabetes, kidney disease, cancer chemotherapy and other conditions. In preclinical studies, CXB909 enhanced the action of NGF in vitro, amplifying its activity almost seven-fold. CXB909 was neuroprotective in a variety of cellular assays and in animal models of neuropathies and neurodegenerative diseases, including chemotherapy-induced neuropathy, for which there is currently no approved treatment... [PDF] CeNeRx BioPharma's Press Release -