First Joint Cortex-Servier High-Impact Ampakine Compound Moves into Phase I Clinical Studies

November 10, 2010 — Cortex Pharmaceuticals, Inc. (OTCBB (CORX)) announced that it had been notified by Les Laboratoires Servier (“Servier”), France’s largest privately held pharmaceutical company, of their intent to move forward into Phase I clinical studies with the jointly-discovered High Impact AMPAKINE® compound S47445 (CX1632).

“We are very pleased with the progress Servier has made with moving S47445 through pre-clinical efficacy, safety and toxicology studies, and into man in the near future” said Mark Varney, Ph.D., Cortex’s President and Chief Executive Officer. “The High Impact AMPAKINE technology represents a potential disease-modifying approach to treat Alzheimer’s disease and other memory and cognitive impairments associated with a range of neurodegenerative diseases because of the ability of the compounds to stimulate growth factors within the brain.”

In October 2000, Cortex entered into a Research Collaboration Agreement and a license Agreement with Servier, which was completed at the end of 2006 and permitted Servier another year to select three compounds for development. Servier selected S47445 for further development, and discontinued development of the other two compounds. Under the License Agreement, Servier can develop and distribute S47445 in Europe, Asia, the Middle East and certain South American countries as a treatment for neurodegenerative diseases and anxiety disorders. Cortex retains the rights to develop and distribute S47445 in North America, most of South America, Australia and New Zealand.

“Cortex applauds Servier for their persistence in bringing this compound forward,” said Dr. Varney. “This announcement is great news for both our companies and for the many patients who suffer from Alzheimer’s disease and other neurodegenerative diseases.”

Dr Emmanuel Canet, head of Servier R&D commented, "Discovery of new therapeutic approaches for neurodegenerative disorders such as Alzheimer disease remains a major challenge and it is by joining forces through collaborations such as the one developed with Cortex, that we will be able to move forward to the clinic with innovative drugs for these diseases. S 47445 fulfills all the criteria needed to enter clinical research and development as this High Impact AMPAKINE has demonstrated a compelling profile of activity in pre-clinical models. We now are looking forward to evaluating its clinical benefit in Alzheimer disease patients"... Cortex Pharmaceuticals's Press Release -

APR and Labtec : exclusive License Agreement with Ferrer Internacional

APR Applied Pharma Research s.a. and Labtec GmbH Enter Into Exclusive Licensing Agreement With Ferrer Internacional for the Registration and Marketing of Donepezil Oral Dispersible Film

10/01/10 - APR and its development partner Labtec have entered into an exclusive licensing agreement with the leading European pharmaceutical company Ferrer Internacional (Ferrer) for the promotion, distribution and marketing of Donepezil Oral Dispersible Film (ODF) in Spain, Portugal and Germany. Terms of the deal were not disclosed.

“It is an honor to work with a dedicated and professional company like APR. Donepezil Rapidfilm with its unique delivery system will be part of Ferrer’s CNS portfolio and is in line with our overall aim to bring new treatment alternatives for our patients,” said José Luis Fumanal, Vice President Domestic Operations Pharma of Ferrer. “As Ferrer has a successful track record in licensing collaborations, we are convinced that the current agreement with APR will be the initiation of another long-lasting partnership strengthening our supportive care line for our patients.”

“Market trends are clear,” said Paolo Galfetti, CEO of APR. “The future of many molecules to become off-patent such as Donepezil will be determined by dosage form diversification and patient compliance. ODF certainly is the oral dosage form contributing the most to compliance by ensuring drug delivery while being easy to use without any discomfort for patients and doctors. We are also very pleased that such a reputable company as Ferrer Internacional took the Donepezil ODF opportunity for such key markets in Europe. I would also like to express my appreciation for the great co-operation we had from Bioselenia, our strategic licensing partner, that helped to build the connection between APR and Ferrer Internacional on this deal.”... Labtec's Press Release - Applied Pharma Research's Press Release -

ExonHit Therapeutics : promising data on genomic biomarkers in Alzheimer’s disease clinical trials

November 8, 2010 - Aid in the selection of a homogeneous patient population to increase chances of successful study outcomes - Identification of biomarkers to predict response to treatment or monitor efficacy - ExonHit Therapeutics (Alternext: ALEHT) announced that promising data regarding the use of blood-based genomic biomarkers in Alzheimer’s disease (AD) clinical trials were disclosed in two distinct oral presentations at the Third Conference of Clinical Trials on Alzheimer’s Disease (CTAD) from November 3rd to November 5th in Toulouse, France.
The CTAD 2010 brought together current thought leaders involved in AD clinical trials to discuss in particular new results, new drug development, and methodological items (disease modifying outcomes, biomarkers, etc…).
To date, clinical trials designed to evaluate a new treatment for Alzheimer’s disease select patients based on clinical criteria, using psychometric scales, brain imaging and measurements in
cerebrospinal fluid. AD being a complex disease with multiple clinical manifestations, clinical trial results are sometimes difficult to interpret due to the heterogeneity of the patient population. Similarly, treatment response in AD is mainly assessed using psychometric scales with results that also vary according to the rater’s experience or the patient’s disposition.
“Including the use of a simple blood-based molecular biomarker such as AclarusDx™ in Alzheimer’s disease trials may facilitate the recruitment of a more homogeneous Alzheimer patient population and thus contribute to reduce random noise in trial results, hence making it easier to evaluate a drug’s potential efficacy,” stated Professor Serge Gauthier, M.D. from McGill University in Montreal. “In addition, drawing blood from patients can be done almost anywhere and is much easier than collecting cerebrospinal fluid in an aged and fragile patient population.”
“Thanks to the development of comprehensive profiling technologies such as our SpliceArray™ platform, pharmacogenomic analysis can be applied in clinical trials to develop predictive or monitoring biomarkers that can be used to identify patients who will benefit from a treatment or to follow their response to that treatment. This is what we have done with EHT 0202, our Phase II compound in Alzheimer’s disease,” added Matthew Pando, PhD, Executive Vice President, Therapeutics of ExonHit Therapeutics... [PDF] ExonHit Therapeutics' Press Release -

Mind-NRG : Series A financing from Index Ventures

27th October, 2010 - Company developing disease modifying compounds for CNS disorders – Index Ventures, a leading venture capital firm, announced the incorporation and Series A financing of Mind-NRG. The new Company, based in Switzerland, is devoted to the development of NRG-101, a peptidic neurotrophic factor with disease modifying potential that crosses the blood-brain barrier by a receptor-mediated transport to reach its target. Index Ventures has allocated up to € 10m to Mind-NRG, with € 1.5m invested at the start to generate further key data.
NRG-101 will be developed to treat neurological and psychiatric disorders such as Parkinson’s disease, Alzheimer’s disease and schizophrenia. Mind-NRG will initially focus on conducting pivotal in vitro and in vivo experiments to further explore the mechanism of action of the peptide and to assess the activity of NRG-101 in a variety of relevant disease models.
Michèle Ollier, partner at Index Ventures and Chairman of the new company commented: “The investment into Mind-NRG is based on the asset-centric model that Index Ventures has pioneered, in line with our focus on highly innovative, science driven therapeutic projects.”

ProteoSys – a Mainz, Germany based research company, focused on proteomics and system biology – has developed and validated NRG-101 over the last years and has assigned NRG-101 to Mind-NRG in exchange for equity in the newly formed company. “We are very excited to have formed such a strong team in order to exploit the potential of NRG-101” said Helmut Matthies, CEO of ProteoSys... [PDF] Mind-NRG's Press Release -

Milestone transition in Astex Alzheimer’s Disease collaboration with AstraZeneca

25 October 2010 - Astex Therapeutics, the UK based biotechnology company developing targeted therapies for oncology and virology, announced that AstraZeneca has selected a candidate drug from its collaborative drug discovery programme aimed at identifying novel, small molecule inhibitors of beta-secretase - a key enzyme implicated in the progression of Alzheimer’s disease. The selection of a candidate drug triggers a milestone payment to Astex which, under the terms of agreement, is eligible also to receive further milestones during clinical development and royalties on commercialisation of products derived from the collaboration. Financial details were not disclosed.

In the collaboration, Astex applied its fragment based drug discovery approach, Pyramid™, to identify novel lead compounds inhibiting the target. AstraZeneca is responsible for progressing the selected candidate drug through clinical development and eventually onto the market... Astex Therapeutics' Press Release -

Metabolon : Biochemical Understanding of Alzheimers Disease

October 13, 2010 — Metabolon, Inc., leaders in global metabolomics, biomarker discovery and biochemical analysis, announces the publication of “Ablation of the Locus Coeruleus (LC) Increases Oxidative Stress in Tg-2576 Transgenic But Not Wild-type Mice” in the International Journal of Alzheimer Disease. The paper examines the role of the LC on markers of oxidative stress in transgenic mice and was carried out as a collaboration among scientists at Pfizer, Proteostasis Therapeutics, the University of Dundee, Duke University and Metabolon. The paper is co-authored by Orest Hurko, Kurt Boudonck, Cathleen Gonzalez, J. Steve Jacobsen, Peter H. Reinhart, Crowther Daniel, Zoe A. Hughes.

Previous research in this area suggested that differences in inflammatory response observed in humans with Alzheimer disease and mouse models reflect a discrepancy in the state of the LC, the major site of norepinephrine synthesis in the brain. LC degeneration is an early change in human Alzheimer disease, but it is preserved in transgenic mouse models of Alzheimer disease... Metabolon's Press Release -

Star Scientific : Roskamp Institute's Plans to Conduct Human Alzheimer's Clinical Trials Using a Compound (RCP-006) Developed by Rock Creek Pharma...

Oct 07, 2010 - Star Scientific, Inc. (Nasdaq: CIGX) has issued the following comment by Paul L. Perito, Rock Creek Pharmaceuticals' Chairman and CEO:
"We are gratified that the Roskamp Institute, a highly credentialed scientific foundation, has made a significant medical discovery that we believe holds the potential for creating a therapy that could play a role in alleviating the scourge of Alzheimer's Disease. We are equally grateful that our talented scientific and medical team, inspired by the creativity of our parent company's founder, Jonnie R. Williams, has developed a compound, RCP-006, which the Roskamp Institute believes merits human clinical trials. We trust that these trials will determine the effectiveness of RCP-006 in treating this debilitating disease... Star Scientific's Press Release -

Roche and reMYND's DDD : strategic alliance to develop first-in-class disease-modifying treatments for Alzheimer's and Parkinson's disease

07-09-2010 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and reMYND announced that they have entered into an agreement to develop novel therapeutics that could slow down neurodegeneration in Parkinson’s and Alzheimer’s patients by inhibiting α-synuclein and tau toxicity.

The collaboration will focus on two of reMYND’s pre-clinical small molecule programmes targeting α-synuclein and tau related pathologies in appropriate model systems as well as potential back-up classes. Roche and reMYND will form joint teams to progress the programmes towards clinical studies. Roche will provide input into chemistry, lead-optimisation and pre-clinical development, while reMYND will continue to conduct non-clinical pharmacology studies and further elucidate the underlying molecular mechanisms. Roche will be responsible for all clinical development and worldwide commercialisation.

reMYND’s compounds are unique because they inhibit α-synuclein neurotoxicity in Parkinson's disease and tau neurotoxicity in Alzheimer's disease. As such they are considered disease modifying, whilst most currently available treatments only treat the symptoms of the disease... reMYND's Press Release -

Aquapharm and Dundee University : Research Collaboration to find Marine Compounds to target Alzheimer's

20th September 2010 - Research agreement combines leading expertise to discover marine natural product inhibitors of O-GlcNAcase - Aquapharm Biodiscovery, a leading marine biotechnology company, announced it has signed a research agreement with Dundee University to help it develop new drugs based on marine natural products that may help in the fight against Alzheimer's.
Alzheimer's is a disease marked by the formation of insoluble protein aggregates in the brain with associated progressive degeneration of the neurons. The collaboration is aimed at O-GIcNAcase, a well-documented target for Alzheimer's, that modulates the solubility of the protein in these aggregates but that has been difficult to target with conventional small-molecule libraries. It therefore forms an ideal opportunity to demonstrate that Aquapharm's growing collection of novel and diverse marine-derived compounds and scaffolds can modulate a clinically attractive but pharmacologically challenging target for a disease for which new solutions are urgently required... [PDF] Aquapharm Biodiscovery's Press Release -

Anavex 2-73: Anti-Amnesic and Neuroprotective Data Against Amyloid Toxicity for First of a New Class in Alzheimer’s Disease

Sept. 13, 2010 – Anavex Life Sciences Corp., (“ANAVEX” or the “Company”) (OTCBB: AVXL) announced that the Journal of Psychopharmacology has published an original paper showing that ANAVEX 2-73 and its only and active metabolite ANAVEX 19-144 alleviate neurotoxicity and cognition deficits associated with Alzheimer’s disease.

The paper, titled “Anti-amnesic and neuroprotective potentials of the mixed muscarinic receptor/sigma 1 ligand ANAVEX 2-73, a novel aminotetrahydrofuran derivative”, is available online at sagepub.com and cites biochemical, morphological and behavioral evidence from experiments conducted jointly between INSERM at University of Montpellier 2 and Anavex Life Sciences Corp.

Validated and well-recognized, standard non-transgenic animal models were used to show statistically significant neuroprotective effects via both muscarinic cholinergic and sigma-1 receptor agonism effects.

The authors compare the pharmacological profile of ANAVEX 2-73 to that of donepezil (marketed as ARICEPT(R)), the leading-selling drug approved for the treatment of Alzheimer’s disease, noting the greater potential benefits of ANAVEX 2-73. Amyloid-beta peptide has been shown to result in mitochondrial and endoplasmic reticulum stress, intracellular calcium dysregulation leading to oxidative stress and apoptosis (cell death). The authors point to the role of ANAVEX 2-73 in prevention of oxidative stress and apoptosis and other data suggesting modulation of Bcl-2 and reactive oxygen species... Anavex's Press Release -

Addex Pharmaceuticals : Drug Candidate Effective in Alzheimer’s Disease Model

2 September 2010 – Allosteric modulation company Addex Pharmaceuticals Ltd (SIX: ADXN) announced that it has observed efficacy in a model of Alzheimer’s disease using a recently discovered orally-available drug-candidate. The proprietary molecule specifically inhibits a receptor subtype called the metabotropic glutamate receptor 2 (mGluR2) via negative allosteric modulation (NAM). An Addex mGluR2 NAM is scheduled to enter Phase I clinical testing in healthy volunteers during 2011.

“Specifically targeting the signaling of the neurotransmitter glutamate using mGluR2 NAM is one of the most promising avenues of research for treating cognitive symptoms of Alzheimer’s disease... Addex Pharmaceuticals' Press Release -

Alectos Therapeutics : Collaboration with Merck to Develop Drugs for Alzheimer’s Disease.

August 11, 2010 - Collaboration Targets a Potential Non-Amyloid Approach to Treating Alzheimer’s Disease – Alectos Therapeutics Inc. announced a research collaboration with Merck, headquartered in Whitehouse Station, N.J., to identify and develop compounds that modulate O linked N-acetylglucosaminidase (O-GlcNAcase) an enzyme that is believed to be involved in the development of Alzheimer’s disease and potentially other disorders. The agreement provides Merck with a worldwide, exclusive license to research, develop and commercialize compounds that modulate this target.
Under the terms of the agreement, Merck has paid Alectos an upfront payment and will fund research to include study of Alectos’ existing portfolio of compounds targeting Alzheimer’s disease. Alectos is eligible to receive a total of US $289 million in an upfront fee, research, development and regulatory milestones and tiered royalty payments on sales of any products resulting from this collaboration.

Alectos and Merck will collaborate on discovery efforts and preclinical development. Merck is responsible for clinical development and will have worldwide marketing and commercialization rights to any resulting products... [PDF] Alectos Therapeutics' Press Release -

Geron : First Human Clinical Trial of Embryonic Stem Cell-Based Therapy and Other Potential Neurological Indications for GRNOPC1

July 30, 2010 - Geron Corporation (Nasdaq: GERN) announced that the U.S. Food and Drug Administration (FDA) has notified the company that the clinical hold placed on Geron's Investigational New Drug (IND) application has been lifted and the company's Phase I clinical trial of GRNOPC1 in patients with acute spinal cord injury may proceed...

[...]

...Additionally, we are now formally exploring the utility of GRNOPC1 in other degenerative CNS disorders including Alzheimer's, multiple sclerosis and Canavan disease."...

[...]

Other Potential Neurological Indications for GRNOPC1

[...]


Alzheimer's Disease: Alzheimer's disease is a progressive, fatal, degenerative disorder that attacks the neurons in the brain, resulting in loss of memory, cognitive function such as reasoning and language, and behavioral changes. According to the Alzheimer's Association an estimated five million people in the United States have Alzheimer's disease. GRNOPC1 is being evaluated in animal models of Alzheimer's disease in collaboration with Professor Frank M. LaFerla, Director of the Institute for Memory Impairments and Neurological Disorders (UCI MIND) at the University of California, Irvine...Geron's Press Release -

Amorfix : New Insights Into Alzheimer's Disease Pre-Clinical Development Mouse Models

July 12, 2010 - Amorfix Quantifies Rate of Accumulation of Amyloid in Seven Mouse Models of AD – Amorfix Life Sciences, a company focused on treatments and diagnostics for misfolded protein diseases including Alzheimer’s disease (AD), has used its A4 test to compare the rate of accumulation of aggregated Abeta in the brain tissue of various mouse models of AD. Amorfix presented this new data at the International Conference on Alzheimer’s Disease (ICAD 2010) this week.
The paper presented by Amorfix entitled “Early Detection of Beta-Amyloid Aggregation in In Vivo and In Vitro Models of Alzheimer’s Disease” characterized seven different AD mouse models by quantitatively measuring the beta-amyloid (Abeta) aggregates in brain tissue from animals 1 month to 14 months of age. The accumulation of Abeta is the hallmark of AD in humans, and a number of cell-culture and animal models have been developed to mimic AD pathology. The A4 (Amorfix Aggregated Abeta Assay) was developed to provide a quantitative method for detection of aggregated species of Abeta... [PDF] Amorfix Life Sciences' Press Release -

Plexxikon : Novel Agent Significantly Inhibits Activation of Key CNS Cells Associated With Alzheimer's Disease

July 14, 2010 - Plexxikon Inc. announced promising preclinical data from in vivo Alzheimer’s Disease studies demonstrating a dramatic reduction in activated microglia in the brains of very old (22 months) 3xTG-AD mice, a triple transgenic model for Alzheimer’s Disease. This reduction of activated microglia led to significantly improved learning in the treated group. PLX3397 is an oral, brain-permeable, potent and selective inhibitor of a kinase target associated with Macrophage Colony Stimulating Factor (CSF-1), a cytokine which is necessary for the activation of microglia and proliferation of macrophages. These cells play key roles in inflammation and cancer. These data were presented yesterday at the Alzheimer’s Association International Conference on Alzheimer’s Disease in Honolulu, Hawaii... Plexxikon's Press Release -

Schwabe Pharmaceuticals : Major study shows that long-term intake of Ginkgo biloba special extract EGb 761® protects against Alzheimer's disease

22 June 2010 - For the very first time, a medicine has been shown to protect against the development of Alzheimer’s disease. French scientists were able to demonstrate that taking 240 mg of Ginkgo extract EGb 761® per day regularly over a period of at least 4 years can cut the risk of developing Alzheimer’s disease by nearly 50%.

“The results of the GuidAge study are remarkable”, according to Prof. Michael Habs, Managing Director at Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, producers of EGb 761® (Tebonin®, pharmacy only). “It is the first time ever that a protective effect against Alzheimer’s disease has been demonstrated for a medicine. The multifaceted effects of the plant extract appear to positively influence the complex developmental processes of dementia.”

The GuidAge study was a large-scale study, in which 2854 elderly people with memory complaints were randomly assigned to receive either 240 mg/day of the patented Ginkgo special extract or a placebo for five years... Dr. Willmar Schwabe Pharmaceuticals' Press Release -

Watson Pharmaceuticals : Generic Exelon

July 1, 2010 - Watson Pharmaceuticals, Inc. (NYSE: WPI) announced that, under a settlement with Novartis Pharmaceuticals Corporation, Novartis Pharma AG, Novartis AG, Novartis International Pharmaceutical Ltd., and Proterra AG (collectively "Novartis"), Watson has commenced shipment of a generic version of Exelon(R) (rivastigmine tartrate) 1.5mg, 3mg, 4.5mg and 6mg capsules.

Exelon(R) is used to treat dementia (a brain disorder that affects the ability to remember, think clearly, communicate, and perform daily activities and may cause changes in mood and personality) in people with Alzheimer's disease... Watson Pharmaceuticals' Press Release -

GTX Corp and Aetrex Worldwide, Inc. : Licensing Agreement to Deliver Patented GPS Shoes Worldwide

June 30, 2010 – GTX Corp (OTCBB: GTXO), a leader in customizable, patented two‐way GPS Tracking Personal Location Services (PLS) solutions, received its first commercial order from Aetrex Worldwide, Inc. , a leading maker of orthotic and therapeutic shoes. Aetrex’s initial order for 3,000 GPS devices to be embedded in the Aetrex Ambulator® collection brings a durable, reliable solution for monitoring the location of the 5.3 million seniors in the US afflicted with Alzheimer’s disease or dementia. GTX will begin to ship the devices this summer in order for Aetrex to prepare for the launch date which is scheduled to coincide with the National Alzheimer Association memory walks this fall.

GTX Corp’s GPS‐enabled shoes provide caregivers and loved ones a safe, unobtrusive means to easily find those afflicted with Alzheimer’s that might wander and become lost. GTX Corp’s eight patents for the GPS Shoe cover a GPS transceiver module that is placed within the shoe. The module transmits the wearer’s location coordinates to a central monitoring station which disseminates the location data through the use of proprietary software, cellular connectivity, the GTX Corp middleware platform and secure viewing portal... [PDF] GTX's Press Release - [PDF] Aetrex's Press Release -

Vermillion : Issuance of Patent for Alzheimer's Disease Diagnosis

June 29, 2010 - Vermillion, Inc., a molecular diagnostics company, announced that the United States Patent and Trademark Office (USPTO) has issued a notice of allowance of a patent entitled "Biomarkers for Alzheimer's disease" to the Company. The patent claims are directed to biomarker combinations for the diagnosis and management of Alzheimer's disease and to the measurement of the biomarkers by a variety of methods, including mass spectrometry and immunoassay... Vermillion's Press Release -

Intellect Neurosciences : Notice of Allowance for Patent on Alzheimer's Drug from the Israeli Patent and Trademark Office

June 9, 2010 / Intellect Neurosciences, Inc (OTCBB: ILNS) announced it has received a Notice of Allowance from the Israeli Patent and Trademark Office for a new patent related to the Company's clinical-stage drug candidate OX1 (OXIGON™), which has disease-modifying potential for Alzheimer's and other neurodegenerative disorders. OX1, which has been successfully tested by the Company in human Phase I safety trials, is an orally-administered, brain-penetrating, naturally-occurring copper-binding small molecule targeting multiple mechanisms that contribute significantly to the underlying pathology of Alzheimer's disease... Intellect Neurosciences' Press Release -

Ipsen : Encouraging results of GuidAge®, large scale European trial conducted in the prevention of Alzheimer’s Dementia

22 June 2010 - Primary efficacy objective (to delay conversion to Alzheimer’s Dementia): - Unmet in overall study population, Met in patients treated for a duration of at least 4 years - The GuidAge® study marks a milestone for future research on Alzheimer’s Disease and for prevention strategies - Ipsen intends to transfer a unique biobank to French Academic research - Ipsen (Euronext: IPN; ADR: IPSEY) announced top line results of GuidAge®, the longest (5 years) and largest (2,854 subjects) European study in the prevention of Alzheimer’s Dementia (AD). This trial was conducted according to the most stringent international standards. The aim of this study was to assess the efficacy of a 5-year treatment with EGb 761® in the prevention of Alzheimer’s Dementia in a population of elderly aged 70 or more, with memory complaint spontaneously expressed to their family physician and who lived at home at the inclusion in the study...

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...About EGb 761®
EGb 761®, which is the active substance of Tanakan®, is a unique standardized extract of Ginkgo biloba. This compound features antioxidant and neuroprotective property as well as an action on β-amyloid protein in experimental models. Its consistent composition in pharmacologically active substances is achieved through specially designed plantations of Ginkgo biloba (dioecious tree in the Ginkgoaceae family) that are cultivated under controlled conditions and a standardised extraction and purification process. EGb 761® is indicated and registered in many countries for the treatment of cognitive disorders in the elderly as well as neurosensory disorders.

About GuidAge®
The aim of the GuidAge® study was to assess the efficacy of EGb 761® at a dose of 240 mg daily in the prevention of Alzheimer’s Dementia (AD) in a population of subjects aged 70 or more with a memory complaint spontaneously expressed to their family physician and living at home at the inclusion. GuidAge® is the longest and largest European study in this disease and has been conducted in full compliance with the most stringent international standards. GuidAge® was a 5-year double-blind randomized trial versus placebo conducted in France by a network of family physicians and memory clinics. The primary endpoint was the incidence of AD during a 5-year follow-up period. A total of 2,854 subjects were enrolled between March 2002 and November 2004. At entry, the mean age of the study population was 76.3 (±4.4), with mean MMSE (Mini Mental State Evaluation) at entry of 27.6 (± 1.9). Last patient last treatment date was November 2009.
The outcomes of the study pointed out that 134 individuals developed dementia of Alzheimer’s type, including 61 patients (4.3%) in the EGb 761® group and 73 patients (5.2%) in the placebo group; this difference was not significant (p=0.31). Global conversion rate found in the placebo group (5.2%) was 50% lower than usually reported in the general French population. In planned pre-specified analysis, results were in favour of EGb 761® in patients treated for at least 4 years (1.6% versus 3.0% in the placebo group, p=0.03) and in males (2.9% versus 7.0% in the placebo group, p=0.007).
Both the dose and indication in the GuidAge® study are not approved by regulatory authorities... [PDF] Ipsen's Press Release -

Forest and Merz : FDA Approval of NAMENDA XR for the Treatment of Moderate to Severe Dementia of the Alzheimer's Type

Jun 21, 2010 - Forest Laboratories, Inc. (NYSE: FRX) and Merz Pharmaceuticals GmbH announced that NAMENDA XR(TM) (memantine hydrochloride) was approved by the U.S. Food and Drug Administration for the treatment of moderate to severe dementia of the Alzheimer's type. NAMENDA XR is a 28 mg once-daily extended-release formulation of NAMENDA. The safety and efficacy of NAMENDA XR were established in a randomized, double-blind, placebo-controlled trial of 677 outpatients already taking a cholinesterase inhibitor. The results indicate that patients treated with NAMENDA XR experienced statistically significant benefits in cognition and clinical global status compared to placebo.


NAMENDA XR will be covered by U.S. Patent No. 5,061,703, which is listed in the Orange Book for NAMENDA and expires in April 2015. In addition, Forest owns pending patent applications related to NAMENDA XR. The companies are determining the appropriate commercialization strategy and market timing to ensure a successful franchise... Forest Laboratories' Press Release -

TauRx : collaborative R&D agreement with Bayer Schering Pharma

June 4, 2010 (New York, NY) - Paves the way for a new paradigm in the early diagnosis and management of Alzheimer’s disease – WisTa Laboratories Ltd, a wholly owned subsidiary of TauRx Pharmaceuticals, announced that they have entered a collaborative R&D agreement with Bayer Schering Pharma AG, Germany, which could redefine the way Alzheimer’s disease (AD) and related disorders are currently being diagnosed and treated.

Through this collaboration, the two companies will develop specific markers that will aid in the diagnostics and management of Tau-protein related AD using brain-imaging technology. The diagnostics they are jointly aiming to develop will have application in disease treatment and potentially disease prevention... [PDF] TauRx Pharmaceuticals' Press Release -

Ablynx and reMYND settle dispute amicably

2 June 2010 – Ablynx NV [Euronext Brussels: ABLX] and reMYND NV announced that they have reached a settlement concerning a dispute relating to a collaboration agreement to discover and commercialize new Nanobodies® which Ablynx and reMYND entered into in 2003. In 2007, Ablynx was notified by reMYND that a difference of interpretation existed in respect of Ablynx's contractual obligation to reMYND under the 2003 agreement.

Under this agreement, Ablynx had the obligation to pay reMYND 50% of any income received if certain Nanobodies from the above collaboration were licensed to a third party for development and commercialization. Ablynx has a collaboration with Boehringer Ingelheim in the area of Alzheimer’s disease with a potential deal value of $265 million plus royalties, under which, at this time, it believes, in contrast to reMYND, that no license to develop or commercialize any of the aforementioned Nanobodies has been granted... [PDF] reMYND's Press Release - Ablynx's newsroom -

LIFETREE CLINICAL RESEARCH® CEO AND CO-FOUNDER NAMED TO ALZHEIMER’S ASSOCIATION, UTAH CHAPETER BOARD OF DIRECTORS

5/27/2010 - The CEO and co-founder of Lifetree Clinical Research® and Lifetree Center for Neuroscience Research, one of the largest specialized clinical research organizations in the Western region of the United States, has been named to the board of directors for the Alzheimer’s Association, Utah Chapter. Alice Jackson will begin her three-year term of service effective May 24, 2010.
"Utah is facing a sharp increase in people with Alzheimer's," said Jack Jenks, executive director of the Alzheimer's Association, Utah Chapter. "The addition of Alice Jackson to our board of directors will ensure that our association will continue to benefit from a diversity of experience, expertise and insight, leading to a cure for this disease."... Lifetree Clinical Research's Press Release -

Senexis : NEXT-GENERATION DISEASE-MODIFYING DRUGS FOR ALZHEIMER’S ENTER PRE-CLINICAL DEVELOPMENT

25th May 2010 - Senexis Limited has identified drug candidates from different and novel chemical series that have shown potential in pre-clinical models, as disease modifying treatments for Alzheimer’s disease. Their success secures the drawdown of further tranche of funding from the Wellcome Trust to support pre-clinical development of the most promising candidates from the SEN1500 series.

Senexis were awarded £2.9 million by the Wellcome Trust, under the Seeding Drug Discovery initiative in 2008, to support selection studies to identify potential drug candidates for pre-clinical development. Successful completion of these studies now triggers the release of funds, enabling Senexis to initiate that planned development and file two further patents to protect this next generation of potentially disease modifying Alzheimer’s drugs.

Using proprietary drug screening technologies, Senexis have identified novel compounds, which target the soluble assemblies of brain proteins that are a toxic form of amyloid. These potential drugs have been selected for their ability to prevent amyloid from aggregating or “clumping together”. The effect of the compounds is to protect against amyloid toxicity, well before the formation of the tell-tale “plaques” that have been used to classify the disease, since the original discoveries of Alois Alzheimer over a century ago... Senexis' Press Release -

Merz and Acumen Partner in An Innovative Alzheimer's Approch

January 12, 2010 – Merz has licensed an innovative drug development program and related technology originated by Acumen Pharmaceuticals, Inc. The license provides Merz certain exclusive global drug development, manufacturing and marketing rights in exchange for upfront and milestone payments to Acumen as well as royalties on future product sales. The drug technology is based on Acumen’s pioneering work on the toxic ß-amyloid protein species appearing very early in dementia of the Alzheimer’s type.


As such, the technology holds great potential in the present quest for a disease-modifying Alzheimer treatment, interfering with the cause, not just the symptoms of one of the most devastating diseases. The development of such an innovative and promising approach therefore complements the successful track record established by Merz’ current anti dementia blockbuster drug, Memantine... [PDF] Acumen Pharmaceuticals' Press Release -

Martek Biosciences : Study Published in Alzheimer's & Dementia: The Journal of the Alzheimer's Association Shows Algal DHA Improved Memory and...

May 3, 2010 - The Memory Improvement with Docosahexaenoic acid (DHA) Study (MIDAS) published online this week in Alzheimer's & Dementia: The Journal of the Alzheimer's Association showed that algal DHA improved memory function in healthy aging adults, providing a benefit roughly equivalent to having the learning and memory skills of someone three years younger.

MIDAS is the first large, randomized and placebo-controlled study demonstrating the benefits of algal DHA in maintaining and improving brain health in older adults. The goal of MIDAS was to evaluate the effects of algal DHA on cognitive outcomes in healthy elderly people with a mild memory complaint. The study was funded by Martek Biosciences.

MIDAS found that healthy people with memory complaints who took 900 mg algal DHA capsules for six months had almost double the reduction in errors on a test that measures learning and memory performance versus those who took a placebo, a benefit roughly equivalent to having the learning and memory skills of someone three years younger. The DHA was well-tolerated and subjects taking the DHA also experienced a lower heart rate, providing a significant cardiovascular benefit.

The study population included 485 people 55 and older at 19 U.S. sites who were considered to have age-related cognitive decline. Age-related cognitive decline is defined as decline in cognitive functioning consequent to the aging process that is within normal limits given a person's age. For example, individuals may report problems remembering names or appointments or may experience difficulty solving complex problems.

MIDAS study participants consumed an oral dose of 900 mg per day of algal DHA or a placebo (corn/soy) over the course of six months. The primary endpoint was a cognitive test of memory and learning called the CANTAB Paired Associate Learning (PAL). CANTAB PAL is an assessment of visual memory and new learning, and is a useful tool for assessing patients with age-related memory loss... Martek Biosciences Corporation's Press Release -

Octapharma : Trial on Intravenous Immunoglobulin (IVIG) in Alzheimer's Disease at ICAD 2010 Congress

April 21st, 2010 - The on-going phase II trial on Octapharma's 10% intravenous immunoglobulin octagam®10% will be a topic at the up-coming International Conference on Alzheimer's Disease (ICAD 2010) to take place in Honolulu, Hawaii from July 10 to 15. Researchers from around the globe will attend ICAD to share groundbreaking research and information on the cause, diagnosis, treatment and prevention of Alzheimer's disease and related disorders.

Octapharma's trial entitled "Prospective 24-week, double-blind, randomized, placebo-controlled, multicenter study evaluating safety and efficacy in mild to moderate Alzheimer’s disease under treatment with increasing dosages of intravenous immunoglobulin (octagam® 10%)" and... Octapharma's Press Release -

Siena Biotech : Roche exercises option on compounds from collaboration with Siena Biotech

March 31st 2010 - New molecules could offer innovative treatment approach for Alzheimer’s Disease - Siena Biotech S.p.A., announced that Roche (SIX: RO, ROG; OTCQX: RHHBY) will exercise its option early to become the lead party for further development, manufacture and commercialization of certain selected candidate molecules for a better treatment of Alzheimer’s Disease.


Under the terms of the collaboration, Siena Biotech has received an undisclosed option exercise fee and is eligible for further success payments upon attainment of certain development and regulatory milestones. Following successful development and commercialization of any of the candidate compounds, Siena Biotech will also receive royalties on product sales: Siena Biotech has retained rights for the further research and development of commonly discovered novel compounds for Orphan indications... [PDF] Siena Biotech's Press Release -

Avid Radiopharmaceuticals, Cardinal Health : Milestone in Innovative Alzheimer's Research

March 25, 2010 — Currently, Alzheimer's disease cannot be definitively diagnosed until after death, when a brain autopsy is performed on a patient and evidence of beta-amyloid plaque deposits in the brain – which are a characteristic pathology of the disease – can be found. Accurate diagnosis during life can be challenging, particularly in the early stages of Alzheimer's, when symptoms are mild and non-definitive. However, Avid Radiopharmaceuticals, Inc. (Avid) and Cardinal Health are working together to change that.

Avid and Cardinal Health announced that more than 100 clinical centers and more than 700 patients have now participated in a Phase III clinical trial that is testing whether Avid's molecular imaging agent Florbetapir F 18 can detect Alzheimer's disease in living patients. Florbetapir F 18 (also known as 18F AV-45 and Florbetapir) is used with positron emission tomography (PET) technology to detect beta-amyloid plaque deposits in the brain... Cardinal Health's Press Release - [PDF] Avid Radiopharmaceuticals' Press Release -

Signum Biosciences : Alzheimer’s Drug Discovery Foundation Funds Signum Biosciences to Move Novel Therapeutics Towards Clinic

Jan 2010 - Signum Biosciences has been awarded a $270K grant from the Alzheimer's Drug Discovery Foundation (ADDF) to investigate, "PP2A: A novel therapeutic target for Alzheimer's Disease". Signum Biosciences' news -
ALZHEIMER’S DRUG DISCOVERY FOUNDATION's Press Release :
MARCH 31, 2010 – The Alzheimer’s Drug Discovery Foundation (ADDF) announced today that it is providing a grant of $270,000 to Signum Biosciences, Inc. (Princeton, NJ) to evaluate small-molecule, orally delivered Protein Phosphatase 2a (PP2A)-modulatory compounds as disease-modifying therapeutics for Alzheimer’s disease.
Signum is developing lipid signal transduction modulators (STMs) for chronic neurodegenerative and inflammatory diseases. Signum’s STM technology, a promising new approach to Alzheimer’s, was licensed from the Princeton University Laboratory of Professor Jeffry Stock, a Signum cofounder and leader in signal transduction research. STMs activate PP2A, a master regulatory protein that, if compromised, can generate signaling imbalances leading to neuronal death and cognitive decline...[PDF] ALZHEIMER’S DRUG DISCOVERY FOUNDATION's Press Release -

Sun Pharma : USFDA tentative approval for generic Namenda® tablets

April 10, 2010: Sun Pharmaceutical Industries Ltd. announced that USFDA has granted its subsidiary a tentative approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Forest Laboratories, Inc.’s Namenda 5 mg and 10 mg tablets.
These generic Memantine tablets are equivalent to Forest Laboratories, Inc’s Namenda® tablets and includes two strengths: 5 mg and 10 mg. These strengths of Memantine have a combined annual sale of approximately $1.2 billion in the US.
Memantine tablets are indicated for the treatment of moderate to severe Alzheimer’s Disease... [PDF] Sun Pharmaceutical Industries' Press Release -

GE Healthcare : positive Phase 2 data with flutemetamol and Phase 3 program now underway

April 9, 2010 – GE Healthcare will present results from its multicenter phase 2 study of flutemetamol at the 4th annual Human Amyloid Imaging (HAI) Meeting in Toronto, Canada. Flutemetamol is a positron emission tomography (PET) imaging agent in development by GE Healthcare, in the field of brain imaging.

The purpose of the phase 2 study was to investigate the efficacy of flutemetamol in differentiating between patients with clinically probable Alzheimer’s disease (AD) and cognitively intact healthy volunteers (HVs). In the study, subjects with a high probability of amyloid (27 AD patients) and a low probability of amyloid (25 healthy subjects) underwent PET imaging with flutemetamol... GE Healthcare's Press Release -

BELLUS Health : launch of NRM8499 Phase I clinical study for the treatment of Alzheimer's disease

April 1, 2010 - BELLUS Health Inc. (TSX: BLU) ("BELLUS Health" or the "Company") announced that, on March 30, 2010, the Company initiated a Phase I clinical study for NRM8499, a prodrug of tramiprosate. NRM8499 is intended for the treatment of Alzheimer's disease. The randomized, double-blind, placebo-controlled study will investigate the safety, tolerability and pharmacokinetic profile of NRM8499 in a group of up to 84 young and elderly healthy subjects.

NRM8499 was previously identified by BELLUS Health as a compound which increases the brain exposure to tramiprosate. Preclinical studies conducted in rodents showed that NRM8499 increased plasma and brain exposure to tramiprosate by 1.5 to 3 fold. The Company believes that an increase in the exposure of tramiprosate to the brain may help improve the therapeutic effect on cognitive function and other clinical outcomes in Alzheimer's disease.

"We are very excited about the launch of the NRM8499 Phase I clinical study. The knowledge acquired through the tramiprosate development program concerning this compound, along with our enhanced understanding of Alzheimer's disease acquired through more than 15 years of preclinical and clinical research in this field, leads us to believe that the potential for NRM8499 is extremely promising,"... BELLUS Health's Press Release -