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SAINT-LAURENT, QUEBEC -- (Marketwired) -- 11/09/17 -- IntelGenx Corp. (TSX VENTURE: IGX)(OTCQX: IGXT) (the "Company" or "IntelGenx"), today announced that it has submitted a clinical trial application ("CTA") to Health Canada for approval to initiate its Phase 2a proof of concept ("POC") study with Montelukast in mild to moderate Alzheimer's Disease ("AD").
The study, entitled "A randomized Phase IIa, multi-center, double-blind, placebo-controlled study to assess the safety, feasibility, tolerability, and efficacy of a new buccal film of Montelukast in patients with mild to moderate Alzheimer's Disease," is to be conducted at eight study sites, and will measure several safety and efficacy endpoints following daily dosing for 26 weeks.
IntelGenx is working to repurpose Montelukast as a therapeutic to treat neurodegenerative diseases by re-formulating the drug into an oral film-based product. Currently, Montelukast is marketed as Singulair®, a once daily tablet for the chronic treatment of asthma and seasonal allergic rhinitis. The drug was first approved by the U.S. Food and Drug Administarion in 1997 and has a very good safety profile. IntelGenx' proprietary VersaFilm technology offers several potential advantages over the tablet form of Montelukast, including the avoidance and minimization of first-pass-effects, improved API bioavailability, lower dosing and toxicity, easier swallowing and better patience compliance.
In a recent Phase I 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.
"This is IntelGenx's first ever Phase 2 study, and the CTA submission is a major milestone for our Company and an important step in the repurposing of Montelukast as a therapeutic to treat degenerative diseases of the brain," commented Dr. Horst G. Zerbe, President and CEO of IntelGenx.
Final details of the Phase 2a POC clinical trial evaluating the safety and efficacy of Montelukast for treating mild to moderate AD will be announced after it has been cleared by Health Canada.
About Montelukast VersaFilm:
Montelukast is a leukotriene receptor antagonist used for the maintenance treatment of asthma and to relieve symptoms of seasonal allergies. 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's Montelukast film offers a distinct dosage form that improves bioavailability and removes the need for water intake. The latest formulation successfully demonstrated enhanced bioavailability as compared with the brand tablet in a pilot study.
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.
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.Contacts: IntelGenx Technologies Corp. Stephen Kilmer Investor Relations (514) 331-7440 ext 232 IntelGenx Technologies Corp. Andre Godin, CPA, CA Executive Vice-President and CFO (514) 331-7440 ext 203 NEXT ARTICLE
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