Earlier this year, IntelGenx initiated a Phase 2a proof of concept Montelukast VersaFilm™ clinical trial in Alzheimer’s disease (“AD”) patients, following clearance of the Clinical Trial Application by Health Canada.  The Phase 2a Montelukast Versafilm™ clinical trial is a randomized, double-blind, placebo controlled POC study that will enroll approximately 70 subjects with mild to moderate AD across eight Canadian research sites.  The primary study objectives will be to evaluate the safety, feasibility, tolerability, and efficacy of Montelukast buccal film following daily dosing for 26 weeks. 

IntelGenx' proprietary VersaFilm™ technology is especially suited for special needs patient populations, and the Montelukast VersaFilm™ product, therefore, offers many distinct advantages over tablets for AD 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.

As highlighted in the Alzheimer's & Dementia article, which can be accessed on the internet at https://www.alzheimersanddementia.com/article/S1552-5260(18)30041-4/pdf or by visiting the “Montelukast” link in the Product section of http://www.intelgenx.com, neuronal damage to the brain can impair basic bodily functions, such as swallowing, as AD progresses.

Quoting directly from the article, “Damage to areas of the brain that control swallowing makes it difficult to eat and drink.  This can result in individuals swallowing food into the trachea (windpipe) instead of the esophagus (food pipe). Food particles may be deposited in the lungs and cause lung infection.  This type of infection is called aspiration pneumonia, and it is a contributing cause of death among many individuals with Alzheimer’s.”

"There are limited treatments available for AD and, of those that are approved, none are in a film version," said Dr. Horst G. Zerbe, President and CEO of IntelGenx.  "A recent paper published in the journal, Immunity & Aging, noted that Montelukast has been shown to rejuvenate aged brains in an animal model and suggested that this leukotriene receptor antagonist may have a similar effect in humans.  The disease modifying potential of Montelukast, combined with the fact that buccal film does not need to be swallowed like a tablet, leads us to believe that it may become a game-changer in treating AD patients."

In an earlier 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 ' oral film also crossed the blood-brain barrier, an essential feature for treating degenerative brain diseases.

Alzheimer's & Dementia is a peer-reviewed journal that aims to bridge knowledge gaps separating traditional fields of dementia research by covering the entire spectrum from basic science to clinical trials and social and behavioral investigations.  In July 2008, Alzheimer's & Dementia was accepted for indexing by MEDLINE, the premier bibliographic database of the National Library of Medicine, part of the National Institutes of Health.  Inclusion in this prominent database signals recognition of the journal's scientific merit and contribution to the field of Alzheimer's research.  In 2014, Alzheimer's & Dementia had the second highest impact factor from among nearly 200 journals in its category.  Impact factor reflects how often articles in a journal are cited by researchers and measures a journal's influence in the field.

About Montelukast VersaFilm™:

Montelukast was approved by the U.S. Food and Drug Administration in 1997 for the treatment of asthma and seasonal allergic rhinitis.  Montelukast is a CysLT1antagonist; it blocks the action of leukotriene D4 (and secondary ligands LTC4 and LTE4) on the cysteinyl leukotriene receptor CysLT1 in the lungs and bronchial tubes by binding to it. This reduces the bronchoconstriction otherwise caused by the leukotriene and results in less inflammation.

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 ' Montelukast buccal film offers a distinct dosage form that improves bioavailability and removes the need for water intake.

About IntelGenx:

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' highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services.  IntelGenx' state-of-the-art manufacturing facility, established for the VersaFilm™ technology platform, supports lab-scale to pilot and commercial-scale production, offering full service capabilities to its clients. More information about the Company can be found at www.intelgenx.com.

Forward Looking Statements:

This document may contain forward-looking information about IntelGenx' operating results and business prospects that involve substantial risks and uncertainties. Statements that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, but are not limited to, statements about IntelGenx' plans, objectives, expectations, strategies, intentions or other characterizations of future events or circumstances and are generally identified by the words "may," "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates," "could," "would," and similar expressions.  All forward looking statements are expressly qualified in their entirety by this cautionary statement.  Because these forward-looking statements are subject to a number of risks and uncertainties, IntelGenx' actual results could differ materially from those expressed or implied by these forward-looking statements.  Factors that could cause or contribute to such differences include, but are not limited to, those discussed under the heading "Risk Factors" in IntelGenx' annual report on Form 10-K, filed with the United States Securities and Exchange Commission and available at www.sec.gov, and also filed with Canadian securities regulatory authorities and www.sedar.com.  IntelGenx assumes no obligation to update any such forward-looking statements.

Each of the TSX Venture Exchange and OTCQX has neither approved nor disapproved the contents of this press release.

Source:  IntelGenx Technologies Corp.

For more information, please contact:

Stephen Kilmer
Investor Relations
(514) 331-7440 ext. 232
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Or

Andre Godin, CPA, CA
Executive Vice-President and CFO
IntelGenx Corp.
(514) 331-7440 ext. 203
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Source: IntelGenx Technologies Corp.