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IntelGenx Announces Montreal’s Douglas Mental Health University Institute as Ninth Montelukast VersaFilm™ Phase 2a Clinical Trial Site
Renowned Neurologist Dr. Serge Gauthier to Serve as Site’s Lead Investigator
SAINT LAURENT, Quebec, Feb. 14, 2019 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT) (“IntelGenx”), a leading oral drug delivery company, today announced that, subject to final research ethics board approval, Montreal’s Douglas Mental Health University Institute has agreed to participate in IntelGenx’s Montelukast VersaFilm™ Phase 2a clinical trial in patients with mild to moderate Alzheimer’s Disease (AD). In addition, IntelGenx is honoured to announce that world-renowned neurologist and clinical researcher, Serge Gauthier MD, FRCPC, has agreed to serve as the site’s lead investigator.
Dr. Gauthier is a Professor in the Departments of Neurology & Neurosurgery, Psychiatry and Medicine at McGill University; and Director of the Alzheimer Disease and Related Disorders Research Unit of the McGill Center for Studies in Aging at Douglas Hospital. Dr. Gauthier is also the founder of the Canadian Consortium of Centers for Clinical Cognitive Research (C5R), a not-for-profit research network that facilitates collaboration and partnerships between pharmaceutical companies and Canadian dementia researchers. C5R research sites conduct clinical trials to research and develop treatments for patients with cognitive impairment, AD, as well as other forms of dementia. In addition to authoring numerous research papers, journal articles, and book chapters, he edited an internationally cited textbook titled Clinical Diagnosis and Management of Alzheimer's Disease and co-authored a book for the general public titled La maladie d'Alzheimer: Le guide. Dr. Gauthier was named a member of the Order of Canada in 2015 and Knight of the Ordre National du Québec (2017) for his contributions in the area of Alzheimer’s disease research.
Regarding IntelGenx’s Phase 2a clinical trial, Dr. Gauthier stated, “I am pleased to be a part of this very important study examining the potential of oral film Montelukast to treat this terrible disease.”
“Dr. Gauthier is one of the world’s leading researchers in AD research, and we are delighted that he has agreed to serve as lead investigator of our trial site in Montreal, which, coincidentally, is the city where the tablet formulation of Montelukast was developed,” said Dr. Horst G. Zerbe, President and CEO of IntelGenx. “We are looking forward to obtaining final approval so we can begin patient recruitment at this site.”
The randomized, double-blind, placebo-controlled Phase 2a “proof of concept” study will assess Montelukast VersaFilm™ in patients with mild to moderate AD, and expects to enroll approximately 70 subjects. The study will evaluate the safety, feasibility, tolerability, and efficacy of Montelukast buccal film following daily dosing for 26 weeks.
About Montelukast VersaFilm™:
Montelukast is a leukotriene receptor antagonist that was approved by the U.S. Food and Drug Administration in 1997 for the treatment of asthma and seasonal allergic rhinitis. IntelGenx is working to repurpose Montelukast as a therapeutic to treat neurodegenerative diseases by re-formulating the drug into an oral film-based product. IntelGenx's proprietary VersaFilm™ technology is especially suited for special needs patient populations, and the Montelukast VersaFilm™ product offers many distinct advantages over tablets for Alzheimer’s Disease patients, including the avoidance and minimization of first-pass-effects, ease of administration, improved API bioavailability, lower dosing and toxicity, better acceptability and improved compliance.
In a recent Phase 1 study, IntelGenx demonstrated that an oral film formulation of Montelukast is safe and tolerable in healthy subjects, reduces the first-pass-effect and has a 52% higher bioavailability compared to the regular Montelukast tablet, demonstrating a clear advantage of delivering Montelukast via film. IntelGenx's oral film also crossed the blood-brain barrier, an essential feature for treating degenerative brain diseases.
Established in 2003, IntelGenx is a leading oral drug delivery company primarily focused on the development and manufacturing of innovative pharmaceutical oral films based on its proprietary VersaFilm™ technology platform.
IntelGenx's highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx's state-of-the-art manufacturing facility, which was established for the VersaFilm™ technology platform, offers by supporting lab-scale to pilot- and commercial-scale production. More information about the company can be found at www.intelgenx.com.
Forward Looking Statements:
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Source: IntelGenx Technologies Corp.
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