IntelGenx Corp. and Circ Pharma to Commence Phase 1 Proof-of-Concept Study of CRES Pravastatin, a Novel Low Dose

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Tue May 19, 2009 6:01am EDT

  SAINT LAURENT, QUEBEC AND DUBLIN, IRELAND, May 19
(MARKET WIRE) -- 
IntelGenx Corp. (TSX VENTURE: IGX) (OTCBB: IGXT) ("IntelGenx") and Circ
Pharma ("Circ"), announced today that they completed the formulation
development of CRES Pravastatin (Controlled Release Enhanced Statin), and
will enter the clinical development phase in Q2/2009 to initiate the
proof-of-concept programme.

    This Phase 1 trial is a randomized, single dose, crossover study
comparing CRES Pravastatin to conventional Pravachol tablets in normal
healthy volunteers. The primary objective of this trial is to evaluate
the pharmacokinetics of CRES Pravastatin versus conventional Pravachol
tablets.

    CRES Pravastatin is the first product in a series of Circ Pharma's
controlled release lipid lowering products specifically designed to
target the absorption of drug in order to reduce the effective dose and
potentially lower the side effects. CRES Pravastatin was formulated using
IntelGenx's proprietary VersaTab Tablet Technology. It is intended to
control the amount and rate of statin delivered to the liver from the gut
and is expected to provide significant benefits compared with standard
statin administration, namely increased GI absorption, enhanced
lipid-lowering efficacy at low to medium doses, maximal lipid lowering
effects without an associated increase in systemic exposure, and
decreased variability in plasma bioavailability compared with standard
statins.

    The product may reach the market as early as late 2012. According to IMS
Health, the lipid lowering Market had over $11 billion sales in the US
alone during 2008.

    Dr. Horst Zerbe, President and CEO of IntelGenx said, "We are extremely
pleased with the progress that we are making on this project. The
anticipated successful completion of this clinical study will once again
confirm IntelGenx's unique expertise in the formulation development of
complex drug delivery technologies."

    Margot Foynes, Chief Technical Officer of Circ Pharma, added "We are
looking forward to moving to this important stage of development of the
CRES program, the first statin in a series covered by Circ's broad
intellectual property portfolio."

    About INTELGENX CORP.

    IntelGenx Corp. is a drug delivery company focused on the development of
oral controlled-release products as well as novel rapidly disintegrating
delivery systems. The Company uses its unique multiple layer delivery
system to provide zero-order release of active drugs in the
gastro-intestinal 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. The Company's research and development pipeline includes products
for the treatment of pain, hypertension, osteoarthritis, and depressive
disorders. More information is available about the company at
www.intelgenx.com.

    About CIRC PHARMA LIMITED

    Circ Pharma is a specialty pharmaceutical product development company,
based in Ireland, whose mission is to develop differentiated novel
formulations of products based on existing drugs that provide incremental
patient benefit. Circ Pharma has a strong intellectual property portfolio
and technology in the areas of targeted and chronotherapeutic drug
delivery with pipeline of novel product opportunities in a number of
indications including cardiovascular and CNS/pain indications.

    Cautionary Note Regarding Forward Looking Statements:

    This document may contain forward-looking information about IntelGenx's
and / or Circ'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 and / or Circ'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 and / or Circ'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 for the fiscal year
ended December 31, 2008, filed with the United States Securities and
Exchange Commission and available at www.sec.gov. IntelGenx and / or Circ
assume no obligation to update any such forward-looking statements.


 

The TSX Venture Exchange Inc. and OTCBB have not reviewed and do not
accept responsibility for the adequacy or accuracy of this press release.

Contacts:
IntelGenx Corp.
Dr. Horst G. Zerbe
President and CEO
514-331-7440 (ext. 201)
514-331-0436 (FAX)
horst@intelgenx.com
www.intelgenx.com

Circ Pharma Ltd.
Margot Foynes
Chief Technical Officer
+353-1-6344186
+353-1-6344188 (FAX)
margot.foynes@cirpharma.com
www.circpharma.com

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