IntelGenx Begins Montelukast VersaFilm™ Dosing in Patients with Mild to Moderate Alzheimer’s Disease in Phase 2a Study
November 27 2018 - 8:00AM
IntelGenx Corp. (TSX-V: IGX) (OTCQX: IGXT) (the “Company” or
“IntelGenx”) today announced that patient dosing has commenced in
the Phase 2a study of Montelukast VersaFilm™ in patients with mild
to moderate Alzheimer’s Disease (AD). The True North Clinical
Research site in Kentville, Nova Scotia is the first of eight
research sites in Canada to enrol a patient and commence dosing.
This randomized, double-blind, placebo
controlled Phase 2a proof of concept study will enroll
approximately 70 subjects with mild to moderate AD. The study
will evaluate the safety, feasibility, tolerability, and efficacy
of Montelukast buccal film following daily dosing for 26
weeks. Currently, seven of eight research sites have been
activated and actively recruiting patients.
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 CysLT1 antagonist;
it blocks the action of leukotriene D4, a natural substance
produced in the body involved in inflammation, (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
narrowing of bronchioles otherwise caused by the leukotriene and
results in less inflammation. IntelGenx’s Montelukast
buccal 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.
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'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, 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'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 Kilmer
Investor Relations
(514) 331-7440 ext 232
stephen@intelgenx.com
Or
Andre Godin, CPA, CA
Executive Vice-President and CFO
IntelGenx Corp.
(514) 331-7440 ext 203
andre@intelgenx.com
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