LAB's asthma product shows good safety profile in study; Pomerleau joins board

By Angela McDaniels

Seattle, Jan. 24 - LAB International Inc. said the final safety, tolerability and pharmacokinetic results from a recently completed phase 1 trial show that its asthma product, LAB CGRP (Calcitonin Gene Related Peptide), is safe. No serious adverse events were reported at any of the doses tested.

LAB also announced the appointment of Jean-Marie Pomerleau to its board of directors. Pomerleau is a partner at Demers Beaulne, a Montreal-based chartered accountants and management consultants firm; has more than 40 years of experience in public practice and specializes in business valuations and financial litigation support.

The randomized, double-blind, placebo-controlled dose escalating study administered four inhaled doses of CGRP ranging from 0.025 to 5.0 mg to 10 healthy volunteers.

The results 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 company said.

"The results are in line with our expectations," chief executive officer Halvor Jaeger said in a company news release.

"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 2 clinical trial."

LAB CGRP is a 37 amino acid natural neuropeptide produced in the lung in response to allergic stimuli. In preclinical studies, it has demonstrated a profile that could make it an ideal anti-asthmatic drug candidate with bronchodilator, bronchoprotector and anti-inflammatory properties, according to the release.

LAB International is an integrated drug development company based in Laval, Quebec, that includes LAB Pharma and LAB Research. LAB Pharma develops inhalation-based therapeutics and LAB Research provides contract research services.

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