LAVAL, Jan. 24 /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 the final and complete safety, tolerability and pharmacokinetic results from the recently completed Phase I trial for its novel asthma product, LAB CGRP (Calcitonin Gene Related Peptide). CGRP demonstrated to be safe with no serious adverse events reported at all doses tested.
The randomized, double blind, placebo-controlled dose escalating study was carried out on 10 healthy volunteers. The primary and secondary objectives were to examine the safety and tolerability and the pharmacokinetics of four inhaled doses of CGRP ranging from 0.025 to 5.0 mg.
The results from the administration of CGRP by inhalation demonstrated that there were no clinically significant overall changes in safety laboratory parameters or systematic changes in heart rate, blood pressure or ECG even at the highest dose administrated. The mean endogenous CGRP plasma level before inhalation was 28 pg/ml. Although circulating CGRP increased in a dose- dependent manner following inhalation at the 1mg and 5mg doses, thus demonstrating the desired lung exposure, the CGRP plasma concentrations were not high enough to cause any significant side effects such as decrease in blood pressure or flushing. CGRP plasma concentrations at the 0.025mg and 0.1mg doses were not significantly different from that of endogenous CGRP or placebo. Cmax of 38 pg/ml at 1mg and 78 pg/ml at the 5mg dose (31 to 125 pg/ml range) at Tmax of 5 minutes were achieved, as compared to 28 pg/ml for placebo, a 2.8 fold increase. The AUC(0-15 min) at 5 mg dose was 2.5 higher than the placebo.
GCRP is known to be a potent vasodilative agent in the systemic circulation, and hence it is important to establish a good safety profile of the drug when administered into the lung, i.e. the local site of action.
“The results are in line with our expectations. The safety profile of CGRP, especially the absence of severe hypotensive reactions in healthy subjects at all doses indicates that circulating CGRP should not increase significantly enough over the endogenous blood level to cause side effects at the anticipated therapeutic levels to be used and allows us to confidently proceed as planned with our first Phase II clinical trial,” said Dr. Halvor Jaeger, Chief Executive Officer of LAB International Inc.
LAB also announces the appointment of Mr. Jean-Marie Pomerleau to its Board of Directors. Mr. Pomerleau is currently a partner at Demers Beaulne, a Montreal based chartered accountants and management consultants firm. Mr. Pomerleau has more than forty years of experience in public practice and is specialized in business valuations and financial litigation support.
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 bronchodilator, bronchoprotector and anti-inflammatory properties.
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 70.0 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,mainvillel@labinc.ca; Frederic Dumais, Director, Communication and InvestorRelations, (450) 973-2240 ext. 1207, Fax: (450) 973-2259,dumaisf@labinc.ca; Kim Sutton Golodetz, Investor Relations (U.S.A), (212)838-3777, Fax: (212) 838-4568, kgolodetz@lhai.com
