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Neurodyn Inc. creates Memogain® Advisory Board

Posted on Feb 24, 2014 in News

(February 21, 2014) Neurodyn Inc. commenced a Phase 1A clinical trial of its Alzheimer’s drug Memogain® in December 2013. In order to further support the Memogain Development Program, the company has assembled a advisory board of respected industry leaders to assist and guide the company as it plans the regulatory pathway for this promising Alzheimer’s prescription drug candidate. As a pro-drug of an already approved Alzheimer’s disease drug, with a much improved safety and efficacy profile, Memogain® may qualify for a more rapid and less costly path to market authorization by the US FDA.   Drs. Jim Olds, Chris Fibiger, Barry Greenberg and Mr. Jack Kay were named to the Memogain® Advisory Board. Each of them has made significant contributions in neuroscientific research, drug discovery, and pharmaceutical development worldwide.   Dr. Jim Olds earned his PhD in neurosciences and is currently the Director of the Krasnow Institute for Advanced Study, Professor of Neuroscience as well as Chair of the Department of Molecular Neuroscience at George Mason University, Virginia.  Additionally, he has an academic faculty appointment at the Department of Anatomy and Cell Biology at the Uniformed Services University of the Health Sciences in Maryland. In August 2004, he was named editor-in-chief of the journal Biological Bulletin.   Dr. Chris Fibiger was once among the top 100 most cited scientists in neuroscience. He was formerly Vice President and Global Head of Neuroscience at Amgen, a multinational biopharmaceutical company, where he led worldwide neuroscience discovery efforts ranging from early exploratory research through clinical candidate selection. He is now the Chief Scientific Officer for Medgenesis Therapeutics Inc.   Dr. Barry Greenberg has been involved in Alzheimer’s disease research and drug discovery since 1985. He is now Director of Neuroscience Drug Discovery & Development at the University Health Network and co-directing the Toronto Dementia Research Alliance as Director of Strategy, a consortium involving academic research and the five memory clinics at hospitals affiliated with the University of Toronto to create a citywide dementia research center.   Mr. Jack Kay has worked in the pharmaceutical industry for over 45 years, and, since 1995 has been President and Chief Operating Officer of Apotex Inc., the largest Canadian-owned group of pharmaceutical companies.   “We are thankful to be able to benefit from the guidance and insights of these recognized experts,” says Kenneth Cawkell, Neurodyn’s CEO. “Together, they will bring many years of experience and perspective to our task of optimizing our development strategy for Memogain®and ensure its successful commercialization.”     For more information, please contact: Neurodyn Life Science Inc.               Dr. Denis G. Kay, CSO                        +1 902 314...

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Neurodyn Inc. completes Part I of Memogain® Phase IA Clinical Trial

Posted on Jan 13, 2014 in News

Neurodyn Inc. announced today that its’ Alzheimer’s prescription drug candidate – Memogain® has completed the initial Part I of a Phase IA clinical trial in December 2013 at the Centre for Human Drug Research (CHDR) in Leiden, Netherlands – the leading European centre for the conduct of Alzheimer’s clinical trials. The following is a summary of the initial Part I of the Memogain® Phase IA Single Ascending Dose Clinical Trial conducted in December 2013:   Location: The Centre for Human Drug Research [CHDR] Leiden Netherlands, the leading European center for the conduct of Alzheimer’s clinical trials. Caution: This is an interim report of results in a small group of healthy young adults that were given two doses of Memogain via the intranasal route. Background Problem: Side Effects – Galantamine has been known for thousands of years to be a cognitive enhancer, its main and significant draw-back is its gastrointestinal side effects which limits the dose that could be given and reduces patient compliance. Solution: Pro-drug – Memogain is a pro-drug of Galantamine which has been designed to significantly increase the delivery of galantamine to the brain with the following benefits; Increased effectiveness as cognition enhancer, Absence of gastrointestinal side effects, No requirement for up-titration,  and Disease-modifying activity. Mechanisms of Action – Subsequent to the initial introduction of Galatamine in the mid 90’s, Neurodyn’s scientific team confirmed that Galantamine’s principal mechanism of action was to sensitize acetylcholine receptors to their neurotransmitter acetylcholine. Galantamine also exhibits modest acetylcholinesterase inhibitor activity. These two mechanisms work together to improve cognitive function. Study Design The Memogain Phase IA clinical study is divided in two distinct parts: Part I –a double-blind, placebo-controlled study in healthy young subjects –  two single ascending doses of Memogain (5.5mg and 11 mg); sample size n=16. Part II  – a reference controlled study in healthy elderly subjects (aged 66 and over) – three single ascending doses of Memogain (22mg, 33mg, 3rd dose to be determined), reference-controlled (16 mg oral galantamine, 10mg oral donepezil),  sample size  n=42. Total sample size of Phase IA study: n=58. Part I has been completed – Summary Report; Safety:   The safety data is flawless, in particular when considered that there may be much higher galantamine levels in the brain (delivered via Memogain as a pro-drug), than if galantamine (the active drug) were administered orally. There was no hint of any central or significant peripheral adverse effects. In contrast, at the higher dose of Memogain (11 mg) the equivalent dose of oral galantamine would be expected to have caused severe gastrointestinal side effects in up to 30% of subjects. A transient prickling or burning sensation in the nose was reported by several subjects, however this irritation was considered...

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Harper Government Announces Support for PEI Bioscience Company

Posted on Sep 23, 2013 in News

CHARLOTTETOWN (PE) – September 20, 2013 – The Honourable Gail Shea, Minister of Fisheries and Oceans, on behalf of the Honourable Rob Moore, Minister of State (Atlantic Canada Opportunities Agency), joined company officials at Neurodyn Inc., a Charlottetown-based biotech company, to announce funding to support the development of two new products. Founded in Vancouver, British Columbia, Neurodyn Inc. expanded its research and development activities to Charlottetown where the company utilizes a portfolio approach to identify, validate, and develop bioactives for neuroprotection and the early treatment of neurological diseases. “Our Government understands that the technological advancements being made by our Canadian companies will have a direct link to our future prosperity,” said Minister Shea. “Neurodyn is a prime example of why we continue to invest in innovative companies to create jobs, strengthen our economy and improve the quality of life of Canadians.” The Government of Canada, through ACOA’s Business Development Program, is investing $458,833 to support Neurodyn as it moves forward to develop products for Parkinson’s disease mitigation. “Neurodyn is committed to developing products that promote brain health and ease the burden of those living with Parkinson’s disease”, says Kenneth Cawkell, CEO. “We are grateful to the Government of Canada for its investment in this project and for recognizing these natural products for their outstanding benefits. This investment will enable Neurodyn to bring these products to market ensuring that Parkinson’s patients may soon find a brighter future living with their disease.” Neurodyn is conducting a natural product drug development program with a specific extract of the ginsenosides from ginseng that shows compelling evidence for protection of early stage Parkinson’s disease. Neurodyn is developing two new products to be trade named NeuroPro and NeuroPro PD. Parkinson’s disease is the second-most common progressive neurodegenerative disease and is a significant social and economic cost to society. PEI’s Bioscience Cluster is made up of leaders from business, research, government and academia working together as an ambitious and dynamic team. Currently, the Prince Edward Island Bioscience Industry represents 38 companies and accounts for more than $90 million in sales and employs over 1,000 people. For more information on Neurodyn Inc, please visit www.neurodyn.ca and for more information about biotechnology week activities in Prince Edward Island and across Canada, please visit: http://www.imagenenation.ca. BROADCAST SECTION Fisheries and Oceans Minister Gail Shea joined company officials from Neurodyn Inc. today to announce a significant investment in the company’s research and development activities focused on products that help in the early treatment of neurological diseases. The Government of Canada, through ACOA, has invested more than $458,000 in the Charlottetown-based biotech company as it moves forward with the development of new products for Parkinson’s disease mitigation. -30- For more information: Jana Parker...

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Neurodyn Inc. acquires Memogain® for Dementia in Alzheimer’s Disease

Posted on Sep 4, 2013 in News

Neurodyn Inc. announced today that it has acquired from Galantos Pharma GmbH, Mainz, Germany (galantos.com) all assets related to their Alzheimer’s prescription drug candidate – Memogain®.  Memogain® has completed an extensive preclinical development program and is ready to proceed into Phase 1 clinical trials in late 2013.  The terms of the acquisition were not disclosed. “We are very pleased to complete this acquisition.  Memogain® is a significant improvement over existing Alzheimer’s drugs, and is staged for immediate entry into clinical trials.  It has the potential to follow a fast-track regulatory pathway in both the US and Europe.” said Kenneth Cawkell, Neurodyn CEO. Memogain® is a patented improvement on the generic drug, galantamine, (Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine).  Galantamine, a plant-derived compound, is widely prescribed to enhance cognition for the treatment of mild to moderate Alzheimer’s disease, but has a limited capacity for brain penetration and significant side effects that limit its effectiveness. Memogain® was developed to have a much higher bioavailability in the brain, without the negative gastro-intestinal side effects that limit patient acceptance. Neurodyn will also investigate the potential for Memogain® to decrease the amyloid plaque burden associated with Alzheimer’s disease and to induce new cell growth in regions of the brain affected by the disease. Sales of galantamine are currently in excess of $500 million per year.  The worldwide Alzheimer’s drug market is currently estimated to exceed $4.2 billion and is growing rapidly due to the aging demographic.  Current drugs on the market have significant side effects which limit their effectiveness and reduce their usefulness. The revenue potential for Memogain® could extend beyond the current galantamine market share due to the urgent medical need for Alzheimer’s drugs that have increased efficacy and decreased side effects compared to the current anti-dementia drugs. Neurodyn Inc. (www.neurodyn.ca) is a Canadian biotechnology company focused on identifying, validating and developing natural bioactives into both prescription drugs and natural products for the early treatment of neurological diseases.  Neurodyn examines historically-proven natural products to discover key bioactives which can either be reformulated or repurposed to provide more effective treatments for neurological conditions. Neurodyn’s lead technologies include ND1208, a neuroprotectant for use in early stage Parkinson’s disease, which is incorporated into both a nutrition supplement (in market) and a US-FDA Medical Food product (under development), Progranulin (ND602), a novel therapeutic demonstrating pre-clinical efficacy in ALS, Parkinson’s disease, Alzheimer’s disease and Spinal Muscular Atrophy, and a natural product derived Nerve Pain Treatment (NQ1123), which is being developed as a prescription drug for a topical nerve pain condition. Galantos Pharma GmbH (www.galantos.com) is a German biotechnology company founded in 2005 by Professors Alfred Maelicke (Mainz) and Ulrich Jordis (Vienna).  Both have been intimately involved in the...

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Neurodyn Inc. Secures Patent for Diagnostic Technology

Posted on Jul 30, 2013 in News

Neurodyn Inc. announced today that one of its key patents will be issued in the US on July 30th, 2013. US Patent 8,497,123 (Sterol Glucosides Toxins) represents technology derived from the founding intellectual property for Neurodyn. The lead inventor on this patent, Dr. Chris Shaw, University of British Columbia, is a founding shareholder in Neurodyn. This patent protects a diagnostic technology being developed by Neurodyn which has the potential for early identification of individuals at risk of developing Neurological diseases. Neurodyn executives feel the technology could have an extensive socioeconomic impact. “This is a significant opportunity for Neurodyn to develop a revolutionary technology for health care systems around the world,” says Dr. Denis Kay, Chief Scientific Officer, “Early diagnosis is critically important to ensuring a higher quality of life for an individual with a neurological condition, but also in reducing the financial burden on society that is associated with these diseases”. Neurodyn Inc. (neurodyn.ca) is a Canadian biotechnology company focused on identifying, validating and developing natural bioactives into both prescription drugs and natural products for the early treatment of neurological diseases.  Neurodyn examines historically-proven natural products to discover key bioactives which can either be reformulated or repurposed to provide more effective treatments for neurological conditions. Neurodyn partners with pharmaceutical and consumer health players, and will also explore faster alternatives to traditional drug development, such as the professional supplement market and the US FDA Medical Food designation. The company currently has a robust suite of drug candidates, including NeuroPro™- a professionally-oriented supplement; Neuroprotectant (ND1208) – a Medical Food product expected to launch in the USA in 2014; Progranulin (ND602) – a therapeutic demonstrating in vivo pre-clinical efficacy in ALS, PD, Alzheimer’s disease and Spinal Muscular Atrophy; Nerve Pain Treatment (NQ1123) – a class of compounds being prepared as a topical drug for a nerve pain condition. For more information, contact: Dr. Denis Kay 902‐314 0776 (mobile) dgkay@neurodyn.ca Mr. Kenneth Cawkell 604‐619‐0990 (mobile) kcawkell@neurodyn.ca Mr. Robert Cervelli 902‐222‐4391 (mobile) cervelli@neurodyn.ca Neurodyn Inc., Suite 508, NRC‐INH, 550 University Avenue, Charlottetown PE C1A 4P3...

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PEI BIO Industry Hosts Neurological Health Symposium

Posted on Jul 2, 2013 in News

The Prince Edward Island BioAlliance and Neurodyn will present the 4th Annual Biotechnology & Human Health Symposium, July 7- 9, 2013 at Rodd’s Brudenell River Resort, Prince Edward Island. The symposium will provide delegates insight into how inflammatory processes play an important role in the development of many neurological disease conditions and represent key therapeutic targets. The Biotechnology & Human Health Symposium program annually attracts international pharmaceutical companies, early stage companies, medical practitioners, principal investigators in clinical trials, contract research organizations, and investors who are focused on this therapeutic area. Dr. Jackalina Van Kampen, Director of Preclinical Research at Neurodyn Inc. and Adjunct Professor, Department of Biomedical Sciences at UPEI, is Program Chair of the Biotechnology and Human Health Symposium. She says the event will be one of the best yet. “This is shaping up to be a very exciting meeting. The concentration of talent that will be gathered here in PEI will give attendees access to some of the world leaders in our field of neurological research. We are very fortunate to attract speakers renowned in this area of research and I’m very proud to be a part of it.” This year’s event is being made possible with financial assistance of from the Government of Canada, through the Atlantic Canada Opportunities Agency (ACOA). “I am proud of our Government’s continued support for Atlantic Canada’s innovative bioscience sector. These investments help to build our region’s commercialization capacity and strengthen our economy,” said the Honourable Gail Shea, Minister of National Revenue and Minister for ACOA. “I encourage all attending delegates from Canada and around the world to have meaningful discussions and build strong relationships during the 4th Annual Biotechnology and Human Health Symposium.” This year’s program will feature a pre-symposium public lecture with Dr. Patrick McGeer from the University of British Columbia who will present “How to maintain a healthy brain and avoid dementia” on the evening of July 7th at 7:00 pm in Brudenell. The main program on July 8th and 9th will feature 12 leading researchers from across North America, Europe, Israel, and India who will present and discuss the role of neuro-inflammation and autoimmunity in the pathogenesis of neurological disease and the process of translating basic research into clinical practice. Canadian researchers and companies, such as Neurodyn, are doing important work in the areas of neurological disease prevention and therapy development. This Symposium gives local industry the opportunity to showcase the quality of work taking place in Atlantic Canada and provides key connections for industry representatives, as well as providing the general public with beneficial information on research, discoveries, and preventative measures for neurodegenerative diseases affecting Islanders. Organizers have also invited international pharmaceutical organizations, such as Johnson...

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