IntelGenx Completes Positive Bioequivalence Study with Insomnia Thin Film
06 Abril 2011 - 7:00AM
Marketwired
IntelGenx Corp. (TSX VENTURE: IGX) (OTCBB: IGXT) ("IntelGenx")
today announced the completion of a pilot biostudy indicating that
IntelGenx has developed a novel oral film, INT0020, that suggests
bioequivalency to a leading branded product for the treatment of
insomnia. INT0020 has been developed using IntelGenx' proprietary
immediate release "VersaFilm" drug delivery technology.
IntelGenx' President and CEO Dr. Horst Zerbe commented, "We are
very pleased to have successfully completed another human study
with our thin films. Insomnia is a largely untapped, multi-billion
dollar market and our insomnia product is based on one of the
leading medications within its class and could represent a very
large opportunity for us."
Dr. Zerbe added. "Insomnia is a great example of an indication
where convenience and quick onset of action are important for the
patient making this an ideal application for our VersaFilm delivery
system. We have previously completed successful studies in the
areas of migraine, erectile dysfunction, and bipolar disorder. We
are extremely pleased to have added a fourth product to our already
strong pipeline of pharmaceutical films with positive human
pharmacokinetic data."
This was a randomized, two-period, two-way crossover study in
healthy male subjects. The study was designed to determine whether
INT0020 is bioequivalent to a leading anti-psychotic product as
measured by industry standard pharmacokinetic measures, peak plasma
concentration (Cmax) and area under the curve (AUC). The study
results indicate that INT0020 should meet acceptance criteria for
bioequivalency for both Cmax and AUC once IntelGenx decides to
advance the product to the larger pivotal bioequivalency study.
About IntelGenx:
IntelGenx is a drug delivery company focused on the development
of oral controlled-release products as well as novel rapidly
disintegrating delivery systems. IntelGenx uses its unique multiple
layer delivery system to provide zero-order release of active drugs
in the gastrointestinal tract. IntelGenx has also developed novel
delivery technologies for the rapid delivery of pharmaceutically
active substances in the oral cavity based on its experience with
rapidly disintegrating films. IntelGenx' research and development
pipeline includes products for the treatment of pain, hypertension,
erectile dysfunction and depressive disorders. More information is
available about the company at 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 for the fiscal year ended
December 31, 2010, filed with the United States Securities and
Exchange Commission and available at www.sec.gov, and also filed
with Canadian securities regulatory authorities and www.sedar.com.
IntelGenx assumes no obligation to update any such forward-looking
statements.
Each of the TSX Venture Exchange and OTC Bulletin Board has
neither approved nor disapproved the contents of this press
release.
Contacts: IntelGenx Corp. Dr. Horst G. Zerbe President and CEO
+1 514-331-7440 (ext. 201) +1 514-331-0436 (FAX)
horst@intelgenx.com www.intelgenx.com
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