With No Safety Concerns, DSMB Recommends Trial Continues; Dose Increase Planned
With No Safety Concerns, DSMB Recommends Trial Continues; Dose Increase Planned
SAINT LAURENT, Quebec, Oct. 09, 2019 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX-V:IGX)(OTCQX:IGXT) (the “Company” or “IntelGenx”), a leader in pharmaceutical films, today announced that an independent Data Safety Monitoring Board (“DSMB”) completed its first interim analysis of the ongoing Montelukast VersaFilm® Phase 2a (“BUENA”) clinical trial in patients with mild to moderate Alzheimer’s Disease (“AD”).
The DSMB reviewed compiled safety data from 25 subjects enrolled in the BUENA trial, 13 of which have completed 26 weeks of daily treatment. The DSMB did not raise any concerns regarding safety and recommended that the trial continue.
“We are pleased with the DSMB’s positive recommendation and are looking forward to continuing this trial based on preclinical data demonstrating Montelukast VersaFilm’s increased efficacy at higher doses,” commented Dr. Horst G. Zerbe, CEO of IntelGenx. “As we begin to compile early safety and efficacy data and continue enrollment at our Canadian sites, we also plan to evaluate expanding the trial to the United States with the potential filing of an Investigational New Drug Application with the U.S. Food and Drug Administration.”
Recently, Prof. Dr. Ludwig Aigner’s group at the Paracelsus Medical University in Salzburg conducted additional efficacy testing of Montelukast in an AD mouse model in collaboration with IntelGenx. Overall results demonstrated that the treatment effect was dose-dependent, with higher doses of Montelukast significantly increasing the mice’s cognition in two behavioural tests. Detailed results from this testing will be presented at an upcoming medical conference.
Based on this new preclinical data demonstrating that the efficacy of Montelukast VersaFilm is dose dependent, IntelGenx plans to continue the BUENA clinical trial at an increased daily dose, subject to Health Canada approval.
About IntelGenx:
IntelGenx is a leading drug delivery company focused on the development and manufacturing of pharmaceutical films.
IntelGenx’s superior film technologies, including VersaFilm®, VetaFilm™ and transdermal, allow for next generation pharmaceutical products that address unmet medical needs. IntelGenx’s innovative product pipeline offer significant benefits to patients and physicians for many therapeutic conditions.
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 offers full service by providing lab-scale to pilot- and commercial-scale production. For more information, visit www.intelgenx.com.
Forward Looking Statements:
This document may contain forward-looking information about IntelGenx’s 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’s 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’s 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’s 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 at www.sedar.com. IntelGenx assumes no obligation to update any such forward-looking statements.
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Source: IntelGenx Technologies Corp.
For more information, please contact:
Stephen Kilmer
Investor Relations
(514) 331-7440 ext 232
stephen@intelgenx.com
Or
Andre Godin, CPA, CA
President and CFO
IntelGenx Corp.
(514) 331-7440 ext 203
andre@intelgenx.com
