LAVAL, Canada, Oct. 4 /PRNewswire-FirstCall/ - LAB International Inc. ("LAB"), a drug development company focused on developing therapies for the inhalation market, today announced positive results from the first Phase II clinical trial of its LAB CGRP product. LAB CGRP showed statistically significant broncho-protective effects compared to placebo and a similar safety profile to placebo except for transient and mild headaches and flushing in some of the patients.
The objectives of this randomized, double blind, cross-over Phase II study were to investigate the protective efficacy of LAB CGRP on metacholine induced bronchial hyper-responsiveness in adult patients with mild to moderate asthma, to compare this efficacy to salbutamol and placebo and to evaluate the safety and tolerability of LAB CGRP in asthma patients. The trial enrolled a total of 12 patients and reached statistical difference.
Each patient received one dose of LAB CGRP (5mg), one dose of Salbutamol sulphate (500(micro)g) and one dose of placebo. The doses were given in a randomized order and study agents were compared in terms of absolute provocative concentration (PC20) of methacholine causing at least 20% fall in forced expiratory ventilation volume. LAB CGRP increased PC20 in a majority of patients (7 out of 12) while Salbutamol and placebo respectively achieved 11 and 2 out of 12. On average, the PC20 with LAB CGRP was approximately two-fold as compared to placebo (geometric mean 1.97 mg/ml, and 0.95 mg/ml, respectively p<0.05).
"We are very pleased to have demonstrated for the first time in human asthmatics the CGRP bronchodilatory efficacy. Now that we have successfully completed this first Phase II study confirming clinical activity we can confidently pursue additional studies to explore dose optimization and anti-inflammatory properties of LAB CGRP." commented Dr. Halvor Jaeger, CEO of LAB International.
About LAB CGRP
LAB CGRP is a 37 amino acid natural neuropeptide produced in the lung in response to allergic stimuli. As a potential drug, it has demonstrated in preclinical studies a profile that could make it an ideal anti-asthmatic drug candidate with bronchodilatory, bronchoprotecting and anti-inflammatory properties.
About LAB International
LAB is a 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 73.2 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: FredericDumais, Vice-President, Investor Relations, (450) 973-2240 ext. 1207, Fax:(450) 973-2259, dumaisf@labinc.ca
