Neurodyn to present at American Society for Clinical Pharmacology & Therapeutics Annual Meeting 2018

(Charlottetown, PE, March 15, 2018)   Neurodyn Cognition Inc. (‘Neurodyn’ or the ‘Company’) today announced that its’ collaborators from The Center for Human Drug Research (Leiden,NL) will present a poster at the 2018 Annual Meeting of the American Society for Clinical Pharmacology & Therapeutics (ASCPT) taking place from March 21 to 24, 2018, in Orlando, Florida.   The poster will feature pharmacokinetic (PK) and pharmacodynamic (PD) outcomes of a MAD study of its’ Alzheimer disease drug candidate Memogain, with a focus on the improved brain function determined by quantitative EEG. As a prodrug of an approved treatment for Alzheimer’s disease, Memogain has been developed to exhibit increased efficacy, and a reduced side effect profile

“We are very excited about the data we are presenting at ASCPT and remain committed to developing safer and more effective treatments for patients,” says Kay.

“Our study has demonstrated Memogain to be safe with few side effects and showed improvements in sustained attention and working memory in elderly individuals.”

About Neurodyn Cognition

Neurodyn Cognition Inc. ( http://www.neurodyncognition.ca ) is a private Canadian biotech company developing Memogain, a patented prodrug of an approved treatment for Alzheimer’s disease, galantamine (Reminyl®). Memogain’s intranasal administration achieves higher dose levels, with significantly greater brain bioavailability, while avoiding the compliance impairing gastro-intestinal adverse effects of existing symptomatic treatments. In addition to improved cognition the increased brain concentrations enhances the drugs unique and safe mechanism of sensitization of neuronal nicotinic acetylcholine receptors, most notably the alpha-7 subtype, which could result in the potential for disease modifying neuroprotective effects.

About The American Society for Clinical Pharmacology & Therapeutics 

The American Society for Clinical Pharmacology & Therapeutics ( https://www.ascpt.org ) , founded in 1900, is the largest scientific and professional organization serving the disciplines of clinical pharmacology and translational medicine.

For more information, please contact:

Mr. Kenneth Cawkell, Chief Executive Officer

kcawkell@neurodyn.ca  | 1.604.619.0990

Dr. Denis Kay, Chief Scientific Officer

dgkay@neurodyn.ca  | 1.902.314.0776

Neurodyn Appoints Anthony J. Giovinazzo as Director and Executive Chairman

VANCOUVER, BC. – December 19, 2017 – Neurodyn Cognition Inc. (“NCI” or the “Company”), is pleased to announce the appointment of Anthony Giovinazzo as a director and Executive Chairman of the Company.  NCI is focused on the development of Memogain, a prodrug of an approved Alzheimer’s therapy with significantly improved safety and efficacy. Memogain has successfully completed its Phase I clinical trials and is in the process of raising funding for its Phase II development program leading to a pivotal marketing study.

We are pleased to welcome Anthony Giovinazzo to the NCI Board as our Executive Chairman,” said Kenneth Cawkell, CEO of the Company. “Anthony has a tremendous background in drug development and, equally important, in securing the required financing.  His experience will be a significant benefit to the Company as we move forward with the next phase of Memogain’s clinical development program.”

During Mr. Giovinazzo’s career he has raised in excess of US$750 million in private and public equity. Most recently, he was responsible for Cynapsus Therapeutic Inc.’s successful drug development program and subsequent sale to Sunovion Pharmaceuticals Inc., a member of the Dianipon Sumitomo Pharma Group, in a CDN $841 million all cash M&A transaction. Anthony has over 25 years of experience in the biotech industry and has been the recipient of a number of industry honours and awards.

“I am looking forward to joining the NCI team and assisting the Company in completing the successful development and commercialization of Memogain, which could represent a near term commercialization opportunity for the underserved Alzheimer’s market.” said Mr. Giovinazzo.

 About Neurodyn Cognition

NCI is a private Canadian biotech company developing Memogain, a patented prodrug of an approved treatment for Alzheimer’s disease, galantamine (Reminyl®). Memogain’s intranasal administration achieves higher dose levels, with significantly greater brain bioavailability, while avoiding the compliance impairing gastro-intestinal adverse effects of existing symptomatic treatments. In addition to improved cognition the increased brain concentrations enhances the drugs unique and safe mechanism of sensitization of neuronal nicotinic acetylcholine receptors, most notably the alpha-7 subtype, which could result in the potential for disease modifying neuroprotective effects.

For Further Information Contact:

Kenneth A. Cawkell, CEO
Neurodyn Cognition Inc.

439 Helmcken Street, Vancouver, B.C. V6B 2E6

Cell:      1-604-619-0990
Email:   kcawkell@neurodyn.ca

 

The statements made in this news release may contain forward-looking statements that may involve a number of risks and uncertainties.  Actual events or results could differ materially from the Company’s expectations and projections.

Neurodyn Cognition Inc. presents latest data for Memogain® at esteemed events

(November 21, 2017) Neurodyn Cognition Inc. recently presented the latest data from a Multiple Ascending Dose (MAD) study and pharmaco-EEG analysis of Memogain® at the 10th Annual Clinical Trials on Alzheimer’s Disease (CTAD) in Boston, Massachusetts on November 1 to 4.

Memogain® is a patented pro-drug of an existing Alzheimer’s drug, galantamine (Reminyl®, Razadyne®), with 10-15x greater brain bioavailability. The drug has a unique and safe mechanism of sensitization of neuronal nicotinic acetylcholine receptors, most notably the alpha-7 subtype, with strong pre-clinical evidence of disease modification. Memogain has successfully completed an enhanced phase I clinical trial, which demonstrated excellent safety and tolerability even at elevated doses, and additionally indicated improved working memory in both young and elderly healthy subjects. The enhanced tolerability is likely to improve patients’ compliance at all stages of treatment – current estimates of drop–out rates range from 30-50% due to lack of perceived benefit and GI side effects.

Neurodyn Cognition Inc. is also confirmed to present at the British Pharmacological Society’s ‘Pharmacology 2017’ , taking place in London, UK from December 11 to 13, and has a pending abstract submission for the American Society for Clinical Pharmacology and Therapeutics (ASCPT) taking place March 15 t0 18 in Washington, DC.

“This is the first time the British Pharmacological Society’s flagship meeting accepted late-breaking abstract submissions and we are thrilled to be among those accepted and recognized for high-impact science,” says Kenneth Cawkell, Director and CEO of Neurodyn Cognition Inc.

The poster can be viewed here:

Memogain MAD/Pharmaco-EEG Data Poster

About Neurodyn Cognition Inc.

Neurodyn Cognition Inc. (www.neurodyncognition.ca) is a spin-out company of Neurodyn Life Sciences Inc. (www.neurodyn.ca) set up for the purposes of taking Memogain rapidly to the marketplace.  The company maintains offices in Canada and Germany, and is currently conducting clinical trials in Europe.

Neurodyn Cognition Inc. to Present Memogain® Clinical Developments at Neurotech Investing and Partnering Conference

 

(March 28, 2016) Neurodyn Cognition Inc. has announced that it will be presenting the company’s latest Memogain® clinical trial development results at the upcoming Neurotech Investing and Partnering Conference, in Boston, MA at 10:30am EST on Wednesday April 6, 2016.  Mr. Ken Cawkell, Neurodyn Cognition CEO, will be presenting these results as part of a panel session entitled “Treatments for Alzheimer’s and Cognitive Disorders.”  Mr. Cawkell’s talk is entitled, “The Brainchild of Neurodyn Cognition: Memogain’s Clinical Trial Results Overview.”

Memogain® is a patented pro-drug of an existing Alzheimer’s drug, galantamine (Reminyl®, Razadyne®), with 10-15x greater brain bioavailability. The drug has a unique and safe mechanism of sensitization of neuronal nicotinic acetylcholine receptors, most notably the alpha-7 subtype, with strong pre-clinical evidence of disease modification. Memogain has successfully completed an enhanced phase I clinical trial, which demonstrated excellent safety and tolerability even at elevated doses, and additionally indicated improved working memory in both young and elderly healthy subjects. The enhanced tolerability is likely to improve patients’ compliance at all stages of treatment – current estimates of drop–out rates range from 30-50% due to lack of perceived benefit and GI side effects.

“Recent regulatory meetings in the EU suggest that Memogain® could be the next Alzheimer’s drug approved in Europe,” says Ken Cawkell, CEO of Neurodyn Cognition. “EU regulators have commented that Memogain® could qualify for market approval based on a single six-month Phase 2 trial for cognition enhancement.  For this reason, Memogain has the potential to be in the EU market in 2 to 3 years – faster than anything now in the pipeline.”

Discussions with the European Medicines Agency’s (EMA) Innovative Task Force indicate that Memogain may satisfy the criteria for ‘Innovative Medicine’ status that could lead to accelerated marketing authorization. Advice from the EMAs Committee for Medicinal Products for Human Use (CHMP) indicates that a single six month cognition trial may be sufficient for marketing authorization, which could be granted in as little as 24-36 months. Memogain also appears to qualify for 505(b)(2), Breakthrough Therapy and Accelerated Approval status, which provides a shortened route to market for the USA.

Memogain has a unique mechanism of action by enhancing the responsiveness of nicotinic receptors without desensitization. Nicotinic receptors are recognised as important drug targets for improving cognition and behavior and enhancing neuronal survival.  Memogain also has the potential to slow or inhibit disease progression. Both reduced plaque formation and neurogenesis, evidence of disease modification, are well documented in pre-clinical trials.

An enhanced Phase IA clinical trial addressed safety, tolerability, and pharmacokinetics of intranasal Memogain in healthy young and elderly subjects, in comparison to the daily recommended doses of the reference drugs Reminyl and Aricept. Administration of Memogain was safe and well tolerated at all dose levels investigated. The healthy young and elderly subjects in the study were also tested for drug-dependent improvements in cognition.  The cognitive test battery demonstrated effects of Memogain on the adaptive tracking test (measuring eye-hand coordination, vigilance and arousal), and in the visual verbal learning test (VVLT, measuring word learning and recall), suggestive of improved short-term memory capacity.

About Neurodyn Cognition Inc.

Neurodyn Cognition Inc. (www.neurodyncognition.ca) is a spin-out company of Neurodyn Life Sciences Inc. (www.neurodyn.ca) set up for the purposes of taking Memogain rapidly to the marketplace.  The company maintains office in Canada and Germany, and is currently conducting clinical trials in Europe.

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