Lab International Initiates Patient Enrollment In The Extension Of Its Phase IIB Fentanyl Taifun(R) Trial
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- Published on Thursday, 01 February 2007 02:00
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MONTREAL, Canada | Jan 31, 2007 | LAB International Inc. (TSX: LAB, Frankfurt: LD9.F, XETRA: LD9.DE) (“LAB”), a drug development company focused on developing therapies for the inhalation and pain markets, today announced enrollment of the first patient in the extension arm of its Fentanyl TAIFUN® Phase IIb clinical trial. Fentanyl TAIFUN® is a fast-acting Fentanyl formulation delivered using the Company’s TAIFUN® dry powder inhaler platform.
Phase IIb for Fentanyl TAIFUN® 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 to evaluate the effective individual dose for significant pain relief with Fentanyl TAIFUN® in the treatment of breakthrough cancer pain. The required enrolment of 32 patients is expected to be completed by the end of this quarter. The second part is randomized, double-blind, cross-over and placebo controlled, continuing with a total of 28 patients from the open-label part and is expected to be completed before the end of the second quarter of 2007.
“We are extremely enthusiastic about our product and want to finish the second part of the trial as quickly as possible. We are confident that Fentanyl TAIFUN® will continue to demonstrate the same superior therapeutic properties, significant and rapid pain relief previously demonstrated. We strongly believe that Fentanyl TAIFUN® will provide these cancer patients with a superior therapeutic alternative for the treatment of their pain attacks.” said Dr. Halvor Jaeger, Chief Executive Officer of LAB International.
The Company is also pleased to announce the appointment of Dr. Robert O. (Bill) Williams III to its Board of Directors. Dr. Williams was the co-founder and President of PharmaForm L.LC. Dr. Williams is the Johnson & Johnson Centennial Professor of Pharmaceutics at the College of Pharmacy, University of Texas at Austin. Dr Williams is a vastly published author in the fields of pharmaceutical technology and drug delivery with research interests in the development of novel drug delivery systems for oral, pulmonary, nasal, injectable, buccal and topical applications. He is also an inventor on numerous patents and patent applications.
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. Break-through pain episodes are common in cancer patients, often occurring several times a day.
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® 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 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.
SOURCE: LAB International Inc