IntelGenx Receives Positive DSMB Recommendation for Montelukast VersaFilm® Phase 2a Trial
October 09 2019 - 8:00AM
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.
Each of the TSX Venture Exchange and OTCQX has
neither approved nor disapproved the contents of this press
release. Neither TSX Venture Exchange nor its Regulation Services
Provider (as that term is defined in the policies of the TSX
Venture Exchange) accepts responsibility for the adequacy or
accuracy of this release.
Source: IntelGenx Technologies Corp.
For more information, please
contact:
Stephen KilmerInvestor Relations (514) 331-7440
ext 232stephen@intelgenx.com
Or
Andre Godin, CPA, CAPresident and CFOIntelGenx
Corp.(514) 331-7440 ext 203andre@intelgenx.com
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