MONTREAL, Feb. 8 /PRNewswire-FirstCall/ - LAB International Inc. ("LAB"), a drug development company focused on developing therapies for the inhalation and pain markets, today announced it has completed as per protocol requirements patient enrollment in its pilot GHRH Phase IIa study. The last patient out last visit should take place late March 2007 with safety and efficacy data available in May 2007.
The placebo controlled Phase II trial conducted in three centers in Europe is investigating the efficacy and safety of GHRH for the treatment of malnutrition in patients with late pre-dialysis chronic renal failure. The Company anticipates demonstrating an increase in growth hormone secretion and IGF-1 levels as well as improvement in protein turnover, body composition, lipid profiles, nutrient intake, and biochemical indicators of the nutritional and metabolic states.
"The completion of patient enrollment is an important milestone in the GHRH clinical program development. Based on earlier Phase I study results already demonstrating GHRH's strong potency, we believe it has the potential to seriously improve the nutritional status, morbidity and survival rate and even postpone the need for dialysis in many patients. We are now awaiting with great excitement the upcoming Phase II results." said Dr. Halvor Jaeger, Chief Executive Officer of LAB International.
About Malnutrition in chronic renal failure (CRF)
Growth hormone given in pharmacological doses is known to improve nutritional status in CRF patients on dialysis despite growth hormone resistance associated with catabolic disease states. A better response to growth hormone increase induced by exogenous LAB GHRH can be expected in pre-end stage CRF patients since the resistance mechanisms are not as pronounced yet although many patients are already malnourished. CRF is a gradual and progressive loss of the ability of the kidneys to excrete wastes, concentrate urine and conserve electrolytes. CRF usually develops over a number of years as the internal structures of the kidney are slowly damaged.
About LAB's GHRH
LAB's proprietary 29 amino-acid peptide analogue of GHRH is designed to stimulate growth hormone secretion in patients. Positive results from its previous Phase I/II trial showed that after administration of LAB GHRH, a rapid and very significant increase in the levels of growth hormones occurred at all dosage levels with no significant adverse events observed.
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 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 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.
LAB INTERNATIONAL INC.CONTACT: Frederic Dumais, Vice-President, Investor Relations, (514)315-3330 ext. 106, Fax: (514) 315-3325, dumaisf@labinc.ca; www.labinc.ca
