IntelGenx Announces Addition of Ottawa Montelukast VersaFilm® Phase 2a Clinical Trial Site; First Patient in Study Completes...
June 10 2019 - 8:00AM
IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT) (“IntelGenx”), leader in
pharmaceutical films, today announced that it has added a new
Ottawa site in the Montelukast VersaFilm® Phase 2a (“BUENA”)
clinical trial in patients with mild to moderate Alzheimer’s
Disease (“AD”).
BUENA is a randomized, double-blind,
placebo-controlled Phase 2a “proof of concept” study designed to
assess Montelukast VersaFilm® in approximately 70 patients with
mild to moderate AD. BUENA will evaluate the safety, feasibility,
tolerability, and efficacy of Montelukast buccal film following
daily dosing for 26 weeks. To date, the BUENA study has enrolled 23
subjects and completed 26-week treatment for its first subject.
“We are very happy to welcome the trial site in
Ottawa,” said Dr. Horst G. Zerbe, CEO of IntelGenx. “While we are
not able to identify it until final Research Ethics Board approval
is obtained, we are looking forward to patient recruitment starting
at this site in the near future.”
About Montelukast VersaFilm®:
Montelukast is a leukotriene receptor antagonist
that was approved by the U.S. Food and Drug Administration in 1997
for the treatment of asthma and seasonal allergic rhinitis.
IntelGenx is working to repurpose Montelukast as a therapeutic to
treat neurodegenerative diseases by re-formulating the drug into an
oral film-based product. IntelGenx's proprietary VersaFilm®
technology is especially suited for special needs patient
populations, and the Montelukast VersaFilm® product offers many
distinct advantages over tablets for Alzheimer’s Disease patients,
including the avoidance and minimization of first-pass-effects,
ease of administration, improved API bioavailability, lower dosing
and toxicity, better acceptability and improved compliance.
In a recent Phase 1 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's oral film also crossed the
blood-brain barrier, an essential feature for treating degenerative
brain diseases.
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 through 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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