IntelGenx Receives Health Canada Authorization to Proceed with New Amendment for Montelukast VersaFilm® Phase 2a Trial
January 15 2020 - 8:00AM
IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT) (“IntelGenx”), a leader in
pharmaceutical films, today announced that Health Canada has issued
a No Objection Letter in response to IntelGenx’s amended Clinical
Trial Application (“CTA”) for the ongoing Montelukast VersaFilm®
Phase 2a (“BUENA”) clinical trial in patients with mild to moderate
Alzheimer’s Disease (“AD”).
“We are delighted with Health Canada providing
the authorization for IntelGenx to proceed with our amended
protocol, which enables us to continue the BUENA trial at an
increased daily dose,” commented Dr. Horst G. Zerbe, CEO of
IntelGenx. “We are looking forward to continuing enrollment at our
Canadian sites under this amended protocol, which is based on
preclinical data demonstrating Montelukast VersaFilm’s increased
efficacy at higher doses. In addition, we continue to evaluate the
trial’s expansion to the United States via a potential
Investigational New Drug Application filing with the U.S. Food and
Drug Administration.”
IntelGenx’s amended CTA was based on additional
efficacy testing of Montelukast in an AD mouse model, conducted in
collaboration with Prof. Dr. Ludwig Aigner’s group at the
Paracelsus Medical University in Salzburg. As reported in the
manuscript entitled, Montelukast dose-dependently improves
cognitive outcome in the 5xFAD mouse model of Alzheimer’s Disease1,
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. These
results are supported by a case report2 confirming that
Montelukast, when given at higher doses, significantly improves
cognition in patients suffering from memory impairment and
dementia.
1 Michael J. Rabl R., Poupardin R. ,
Tevini J., Felder T., Paiement N., Zerbe H., Hutter-Paier B. ,
Aigner L.2 Rozin, S.I., Case Series Using Montelukast in Patients
with Memory Loss and Dementia. Open Neurol J, 2017. 11: p.
7-10.
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' 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 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 IntelGenx:
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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