SAINT LAURENT, QUEBEC and DUBLIN, IRELAND, May 19, 2009 (Marketwire via COMTEX) -- IntelGenx Corp. (IGX)(US: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.
SOURCE: IntelGenx Corp.
Dr. Horst G. Zerbe
President and CEO
514-331-7440 (ext. 201)