PolyPeptide Laboratories ANNOUNCES POSITIVE RESULTS IN LAB INTERNATIONAL STUDY MEASURING GHRH ANALOG EFFICACY
Torrance, CA, USA, March 21, 2005 – PolyPeptide Laboratories is pleased to announce that LAB International has achieved positive results from its September 2004 Phase I/II trial measuring Growth Hormone (GH) levels over a 24-hour period as a result of Growth Hormone Releasing Hormone (GHRH) dosing. The proprietary 29 amino-acid peptide analog of GHRH is manufactured by PolyPeptide Laboratories at its US facilities in Torrance, CA.
"PolyPeptide has had a long association with LAB International and we are delighted to hear about their recent success with their GHRH analog. This further underlines the increasing importance of peptides as potential drug substances as safe and effective therapeutics," said Rodney Lax, Director of Sales and Marketing at PolyPeptide Laboratories.
The results showed a rapid and very significant increase in the levels of growth hormones at all dosing levels for all subjects after the GHRH administration, giving evidence to the strong efficacy of the drug. Moreover, the study demonstrated the high safety profile of the drug with no significant adverse events reported at all dosage levels.
The randomized, cross-over single ascending dose study was conducted in 10 healthy, non-smoking volunteers aged above 50. Doses ranged from 5 micrograms/kg to 25 micrograms/kg. Each volunteer received all doses including placebo, thus acting as his own control. Growth hormone levels were measured over a 24-hour period. For the 0-4 and 0-12 hour periods, the average increase of GH secretion was found to be statistically significant at all dose levels, being up to 40 times over placebo, evidencing a higher than expected efficacy of the drug. Even at the lowest dose, an immediate, consistent and marked increase in GH levels was observed. No interference on the natural nighttime GH secretion was observed.
About Growth Hormone
Growth hormone therapies are used in diseases characterized by a reduction in growth hormone secretion, such as growth deficiency, lipodystrophy in HIV patients, chronic renal failure, and wasting. GHRH functions by promoting the release of growth hormone by the pituitary gland.
About PolyPeptide Laboratories
PolyPeptide Laboratories is a leading international, privately owned group of companies focused exclusively on the manufacture of active pharmaceutical ingredients based on peptides. PolyPeptide Laboratories manufactures both proprietary and generic peptides for the pharmaceutical industry.
For more information about PolyPeptide Laboratories, visit the website at http://www.polypeptide.com, or contact Rodney Lax, TEL: (310) 782-3569 or (800) 770-0557, FAX: (310) 782-3645, EMAIL: polypeptide@pplusa.com
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® dry powder inhaler platform. Its pipeline also includes therapeutics for asthma, COPD and growth hormones 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 share 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 51.3 million shares outstanding.
For further information about LAB International, visit the website at http://www.labinc.ca/, or contact Frederic Dumais, Director, Communication and Investor Relations, TEL: (450) 973-2240 ext. 1207, FAX: (450) 972-2259, EMAIL: dumaisf@labinc.ca
