MONTREAL, March 5 /PRNewswire-FirstCall/ - LAB International Inc. ("LAB"), a drug development company focused on developing therapies for the inhalation and pain markets, today announced positive results from the open-label arm of its Fentanyl TAIFUN(R) Phase IIb clinical trial. The results from 24 patients demonstrated successful dose titration resulting in effective control of breakthrough pain episodes. Fentanyl TAIFUN(R) is a fast-acting Fentanyl formulation delivered using the Company's TAIFUN(R) dry powder inhaler platform.
All 24 patients were successfully titrated to a dose of 400(micro)g or less. From these first 24 patients, 9 patients titrated to 100(micro)g, 10 patients titrated to 200(micro)g and only 5 patients titrated to 400 (micro)g. The patients experienced significant pain relief (defined as a decrease of at least 2 points on the Numerical Pain Scale, or NPS) in 95% of the pain episodes treated. The estimate of the median time to significant pain relief was 7 minutes. Based on the interim adverse event data, Fentanyl TAIFUN(R) doses have been well tolerated and adverse events recorded were in accordance with previously disclosed Fentanyl TAIFUN(R) clinical trial data therefore suggesting high tolerability of Fentanyl TAIFUN(R) in opioid tolerant cancer patients.
"We are extremely pleased with the strong results from the open-label arm of our Fentanyl TAIFUN(R) Phase IIb clinical trial. They clearly demonstrate once again the superior formulation, technological platform and therapeutic profile of our lead compound," said Dr. Halvor Jaeger, Chief Executive Officer of LAB International. "In order to maintain and strengthen our leading position among inhaled fentanyl developers, we have filed a new patent application on the product, making it more difficult for followers to imitate our unique clinical profile."
The Phase IIb study for Fentanyl TAIFUN(R) is a multi-centered, multinational clinical trial in cancer patients with severe persistent pain on maintenance opioid therapy. The first part of the trial is a single arm, open-label dose titration study to evaluate the effective individual dose for significant pain relief with Fentanyl TAIFUN(R) in the treatment of breakthrough cancer pain. The second part includes 28 responders from the open-label arm randomized to receive the titrated doses or placebo. The double-blind, placebo-controlled extension arm, which is currently underway, is expected to be completed before the end of the second quarter of 2007.
The excellent titration success and very fast onset of action obtained with Fentanyl TAIFUN(R) compares very favorably with data published from trials on transmucosal fentanyl preparations. In these trials, higher doses and a broader titration range have been required, and still the proportion of patients that were successfully titrated was lower, and onset of efficacy much slower. This apparent opioid sparing effect of Fentanyl TAIFUN(R), with a narrow range of titration, is most likely due to the unique pharmacokinetic profile of the product, which combines an essentially immediate absorption of the drug with a prolonged and relatively steady concentration for the duration of a typical breakthrough pain attack.
The company has also recently submitted a new patent application to further protect the position of Fentanyl TAIFUN(R), which is the most advanced inhaled fentanyl product in development.
Chronic pain associated with advanced cancer is commonly treated with strong opioid analgesics, such as fentanyl. Breakthrough pain episodes are sudden and intense flares of pain that "break through" a long-acting continuous treatment, such as a transdermal patch or a slow release tablet. Breakthrough pain episodes are common in cancer patients, often occurring several times a day.
About LAB International
LAB International is an integrated drug development company focused on the growing multi-billion dollar inhalation market. Its lead product, for the treatment of breakthrough cancer pain, is a fast-acting Fentanyl formulation delivered using the Company's TAIFUN(R) dry powder inhaler platform. Its pipeline also includes therapeutics for asthma, COPD, and growth hormone deficiencies.
LAB's common shares trade on The Toronto Stock Exchange ("TSX") under the symbol "LAB", on the Frankfurt Regulated Unofficial Market under the symbol "LD9.F" and on XETRA under the symbol "LD9.DE" with 82.3 million shares outstanding.
This news release contains certain forward-looking statements that reflect the current views and/or expectations of LAB International Inc. with respect to its performance, business and future events. Such statements are subject to a number of risks, uncertainties and assumptions. Actual results and events may vary significantly.
LAB INTERNATIONAL INC.CONTACT: Frederic Dumais, Vice-President, Investor Relations, (514)315-3330 ext. 106, Fax: (514) 315-3325, dumaisf@labinc.ca; www.labinc.ca
