LAB International Completes Patient Enrollment In Fentanyl TAIFUN(R) Phase IIa Trial
LAVAL, April 3 /PRNewswire-FirstCall/ - LAB International Inc. ("LAB"), an integrated drug development company with subsidiaries focused on developing therapies for the inhalation market and on providing contract research services, today announced it has completed patient enrollment for the pivotal Phase IIa trial of its lead product, Fentanyl TAIFUN(R). In accordance to previously disclosed timelines, the Company expects to have results from the study available in June 2006.
The multi-centered, randomized, double blind, placebo-controlled phase II trial is investigating the efficacy and safety of Fentanyl TAIFUN(R) for the treatment of breakthrough cancer pain, monitoring response at different Fentanyl doses. The trial enrolled a total of 122 cancer patients on maintenance opioid therapy for persistent pain.
"The completion of patient enrollment represents an important milestone achievement for LAB. Based on the published results from our recent comparative Phase I study that demonstrated exceptionally rapid absorption after a single inhalation of Fentanyl TAIFUN(R) 200 (micro) g, we await with great excitement the upcoming Phase IIa results" commented Dr. Halvor Jaeger, CEO of LAB International.
Chronic pain associated with advanced cancer is commonly treated with strong opioid analgesics, such as fentanyl. Break-through pain episodes are sudden and intense flares of pain "break through" a long-acting continuous treatment, such as a transdermal patch or a slow release tablet. Break-through pain episodes are common in cancer patients, often occurring several times a day. The only product currently available for the indication is an oral lozenge that requires a 15 minutes application time. In contrast, LAB's Fentanyl TAIFUN(R) has been demonstrated to provide instantaneous availability of fentanyl in the blood (within one minute from inhalation), and is therefore expected to provide more rapid pain relief than any existing non-injectable pain medication.
"Our clinical trial, carried out in eight countries, is one of the largest placebo-controlled trials ever conducted in break-through cancer pain" said Dr. Taneli Jouhikainen, President of LAB Pharma Ltd, "Unlike with any of the other means of administration, delivery with the Fentanyl TAIFUN(R) made it feasible to apply a study design where a rescue medication was very rapidly available for placebo patients, and thus allowed the conduct of a large controlled trial in seriously ill patients"
About LAB International
LAB International (LAB Pharma and LAB Research) is an integrated drug development company. LAB Pharma is 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 Research is a profitable and growing contract research services division supporting its clients base from state-of-the-art facilities in Canada, the US, Denmark and Hungary.
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 70.7 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: visit LAB's website at www.labinc.ca, or contact: Luc Mainville,Chief Operating Officer, (450) 973-2240 ext. 1206, Fax: (450) 973-2259,firstname.lastname@example.org; Frederic Dumais, Vice-President, Investor Relations,(450) 973-2240 ext. 1207, Fax: (450) 973-2259, email@example.com; KimSutton Golodetz, Investor Relations (U.S.A), (212) 838-3777, Fax: (212)838-4568, firstname.lastname@example.org