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LAB International Inc

LAB International to Initiate Phase II Trial for GHRH

Laval, Canada (ots/PRNewswire)

- Malnutrition in Patients With Late Pre-end-stage Chronic Renal
Failure Selected as Clinical Indication for Trial
LAB International Inc. (TSX: LAB), an integrated drug development
company focused on the inhalation market, today announced that, after
completion of a successful dose-response trial, it has selected the
first clinical indication for which it intends to evaluate the
efficacy of its Growth Hormone Releasing Hormone (GHRH) analogue.
GHRH will be evaluated for the treatment of malnutrition in patients
with late pre-end-stage chronic renal failure (CRF, stage 4,
pre-dialysis) in a phase II trial to be initiated during the first
half of 2005.
"It is estimated that approximately 45% of the 400,000 stage 4 CRF
patients in the United States also suffer from malnutrition and that
this condition is not properly addressed with current treatment
options," said Dr. Halvor Jaeger, CEO of LAB. "We anticipate that,
based on the potency our drug demonstrated in our recently completed
Phase I/II study, GHRH will provide therapeutic benefits to the
nutritional status of these specific patients."
LAB's proprietary 29 amino-acid peptide analogue of GHRH is
designed to stimulate growth hormone secretion in patients. In
September, LAB announced positive results from a phase I/II trial
which showed that after administration of GHRH, a rapid and very
significant increase in the levels of growth hormones occurred at all
dosage levels. Moreover, the study demonstrated the high safety
profile of GHRH at all doses administered with no significant adverse
events observed.
"Although growth hormone is known to improve nutritional status in
CRF patients on dialysis, there is also associated growth hormone
resistance at that specific stage. A better response to growth
hormone at physiological concentrations can be expected in
pre-end-stage CRF patients because the resistance mechanisms are not
as pronounced yet many of these patients are already malnourished,"
said Dr. Franz Schaefer, Prof. of Pediatrics and Nephrology at the
University of Heidelberg, Germany. "By improving the nutritional
status of patients at this stage of chronic renal failure, even the
need for dialysis might be postponed, resulting in less morbidity to
patients and significant savings to the healthcare system. Also a
distinct advantage of our GHRH can be expected in patients with
concomitant Diabetes"
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. Late
pre-end-stage CRF is characterised by a low total rate of filtration
of blood by the kidney (15-25 mL/min per 1.73 m(2)). Diabetes and
hypertension are the two most common causes of CRF.
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 approved 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
more than 300 clients from state-of-the-art facilities in Canada, the
US, 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 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.
For further information: visit LAB's website at www.labinc.ca

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

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Plus de actualités: LAB International Inc