SAINT LAURENT, Quebec, Apr 24, 2012--IntelGenx Corp. ("IntelGenx") today announced the commencement of a pivotal bioequivalence clinical trial with its anti-migraine VersaFilm product, an oral thin-film formulation of a leading triptan for the treatment of acute migraine. The screening and recruitment of all subjects for the trial has been completed, and first dosing commenced on April 23, 2012.
As announced in December 2011, IntelGenx filed a Clinical Trial Application with Health Canada and received the No Objection Letter for a phase 1 study, the objective of which is to determine if IntelGenx' product is safe and bioequivalent with the U.S. Food and Drug Administration ("FDA") approved reference product. In the pivotal study, bioequivalence will be determined by pharmacokinetic parameters measuring maximum or "peak" concentration ("Cmax") of the drug observed after its administration, and the Area Under the Curve ("AUC").
"We are very excited to have started this phase 1 pivotal bioequivalence study for our anti-migraine thin film," stated Dr. Horst G. Zerbe, President and CEO of IntelGenx. "We are pleased with the progress of this project to date, and successful completion of this study will be a significant achievement towards filing our next New Drug Application. We believe our proprietary thin film technology will make this product a very competitive product in the migraine space upon approval."
IntelGenx is developing its VersaFilm anti-migraine product in accordance with the co-development and commercialisation agreement with RedHill Biopharma Ltd. ("RedHill"), an Israeli corporation, which was executed in August of 2010. If the results of the clinical trial are positive, and if certain FDA requirements are met, the data will be used by IntelGenx and RedHill for submitting a New Drug Application to the FDA.
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 severe depression, hypertension, erectile dysfunction, benign prostatic hyperplasia, migraine, insomnia, bipolar disorder, idiopathic pulmonary fibrosis, allergies and pain management. 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, 2011, 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.
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