SAINT LAURENT, QUEBEC--(Marketwire - April 6, 2011) - 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.
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.
For more information, please contact
Dr. Horst G. Zerbe
President and CEO
+1 514-331-7440 (ext. 201)
+1 514-331-0436 (FAX)