2004-12-06

LAB International to Initiate Phase II Trial for GHRH


Laval, Canada (ots/PRNewswire) -

- Malnutrition in Patients With Late Pre-end-stage Chronic RenalFailure Selected as Clinical Indication for Trial

LAB International Inc. (TSX: LAB), an integrated drug developmentcompany focused on the inhalation market, today announced that, aftercompletion of a successful dose-response trial, it has selected thefirst clinical indication for which it intends to evaluate theefficacy of its Growth Hormone Releasing Hormone (GHRH) analogue.GHRH will be evaluated for the treatment of malnutrition in patientswith late pre-end-stage chronic renal failure (CRF, stage 4,pre-dialysis) in a phase II trial to be initiated during the firsthalf of 2005.

"It is estimated that approximately 45% of the 400,000 stage 4 CRFpatients in the United States also suffer from malnutrition and thatthis condition is not properly addressed with current treatmentoptions," said Dr. Halvor Jaeger, CEO of LAB. "We anticipate that,based on the potency our drug demonstrated in our recently completedPhase I/II study, GHRH will provide therapeutic benefits to thenutritional status of these specific patients."

LAB's proprietary 29 amino-acid peptide analogue of GHRH isdesigned to stimulate growth hormone secretion in patients. InSeptember, LAB announced positive results from a phase I/II trialwhich showed that after administration of GHRH, a rapid and verysignificant increase in the levels of growth hormones occurred at alldosage levels. Moreover, the study demonstrated the high safetyprofile of GHRH at all doses administered with no significant adverseevents observed.

"Although growth hormone is known to improve nutritional status inCRF patients on dialysis, there is also associated growth hormoneresistance at that specific stage. A better response to growthhormone at physiological concentrations can be expected inpre-end-stage CRF patients because the resistance mechanisms are notas pronounced yet many of these patients are already malnourished,"said Dr. Franz Schaefer, Prof. of Pediatrics and Nephrology at theUniversity of Heidelberg, Germany. "By improving the nutritionalstatus of patients at this stage of chronic renal failure, even theneed for dialysis might be postponed, resulting in less morbidity topatients and significant savings to the healthcare system. Also adistinct advantage of our GHRH can be expected in patients withconcomitant Diabetes"

CRF is a gradual and progressive loss of the ability of thekidneys to excrete wastes, concentrate urine and conserveelectrolytes. CRF usually develops over a number of years as theinternal structures of the kidney are slowly damaged. Latepre-end-stage CRF is characterised by a low total rate of filtrationof blood by the kidney (15-25 mL/min per 1.73 m(2)). Diabetes andhypertension are the two most common causes of CRF.

About LAB International

LAB International (LAB Pharma and LAB Research) is an integrateddrug development company. LAB Pharma is focused on the growingmulti-billion dollar inhalation market. Its lead product, for thetreatment of breakthrough cancer pain, is a fast-acting Fentanylformulation delivered using the Company's approved Taifun(R) drypowder inhaler platform. Its pipeline also includes therapeutics forasthma, COPD, and growth hormone deficiencies. LAB Research is aprofitable and growing contract research services division supportingmore than 300 clients from state-of-the-art facilities in Canada, theUS, and Europe.

LAB's common shares trade on The Toronto Stock Exchange ("TSX")under the symbol "LAB" with 38.8 million shares outstanding.

This news release contains certain forward-looking statements thatreflect the current views and/or expectations of LAB InternationalInc. with respect to its performance, business and future events.Such statements are subject to a number of risks, uncertainties andassumptions. Actual results and events may vary significantly.

For further information: visit LAB's website at www.labinc.ca

ots Originaltext: LAB International IncIm Internet recherchierbar: http://www.presseportal.de

Contact:Luc Mainville, Executive Vice-President and Chief Financial Officer, Tel: +1-450-973-2240 ext. 1206, Fax: +1-450-973-2259, mainvillel@labinc.ca; Frederic Dumais, Director, Communication and Investor Relations, Tel: +1-450-973-2240 ext. 1207, Fax: +1-450-973-2259, dumaisf@labinc.ca; James Smith, Investor Relations, Tel: +1-416-815-0700 ext. 229, Fax: +1-416-815-0080, jsmith@equicomgroup.com

LAB International Inc

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LAB International to Initiate Phase II Trial for GHRH

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