MONTREAL, March 5 /CNW Telbec/ - 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
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
"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
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
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.
For further information:
For further information: Frédéric Dumais, Vice-President, Investor
Relations, (514) 315-3330 ext. 106, Fax: (514) 315-3325, firstname.lastname@example.org;