LAB International Announces Positive Results from its Growth Hormone Releasing Hormone (GHRH) Phase II Trial
MONTREAL, July 12, 2007 /PRNewswire-FirstCall/ - LAB International Inc. ("LAB"), a drug development company focused on developing therapies for the inhalation and pain markets, today announced positive interim results from its pilot GHRH Phase II study. Within 4 weeks of treatment, LAB GHRH induced a highly significant stimulation of endogenous growth hormone (GH) secretion and a marked increase of circulating insulin-like growth factor (IGF-1) as compared to placebo in patients with chronic kidney disease. These endocrine effects were associated with a significant increase in Fat Free Mass (FFM) and concomitant reduction in Fat Mass (FM) when measured by DEXA scan. While stable isotope studies did not reveal significant changes in protein turnover within 4 weeks of treatment, a trend towards increased protein synthesis in the LAB GHRH arm was observed.
The time-integrated 24-hour endogenous GH concentration after 4 weeks of LAB GHRH was increased 5-fold compared to the pre-treatment levels, whereas no significant change in GH secretion was observed in the placebo group. (p = 0.0024 for difference of means). The difference was even more striking when GH concentration was evaluated in the first 4 hours post treatment with the mean representing a 12-fold increase against baseline following LAB GHRH injection and a 1.3 fold increase after placebo. The effect of LAB GHRH treatment on circulating IGF-1 was already evident after 7 days of administration with a median total IGF-1 plasma level of 576 vs. 337 ng/ml in the placebo group (p=0.0006). IGF-1 levels remained elevated throughout the entire treatment period with the median reaching 684 ng/ml vs. 398 ng/ml for placebo (p=0.0001) on day 28. When compared to baseline (Day 0), there was on Day 28th of treatment a 2-fold increase in total plasma IGF-1 concentration in LAB GHRH arm and no substantial increase (1.1) in the placebo group.
In comparison to placebo, LAB GHRH increased fat-free mass (FFM) within 4 weeks of treatment by an average of 2.9 kg (p=0.02) (difference of means). In LAB GHRH group, the mean FFM value increased statistically significantly by 1.8 kg and in placebo decreased by 1.39 kg when compared to baseline. The mean Fat Mass (kg) increased in placebo by 1.2 kg and decreased by 0.5 kg in the LAB GHRH arm when compared to the pre-treatment level. When calculated as ratio of means, total body fat mass % on day 28 was reduced by 17% in LAB GHRH group compared to placebo (p=0.01).
The placebo controlled, double-blind Phase II trial conducted in three centers in Europe investigated the efficacy and safety of LAB GHRH applied twice daily subcutaneously (1mg/dose) for 28 days in malnourished patients with advanced pre-dialysis chronic renal failure. The remaining safety and efficacy parameters of nutritional and metabolic state as well as the final analysis of all the study data collected should be available in Q3 2007.
"The results exceeded our expectations for a treatment protocol limited to 28 days. We have demonstrated a marked stimulation of growth hormone and IGF-1 production by our compound, which rapidly triggered a remarkable and highly significant increase in lean body mass and decrease in body fat. We believe LAB GHRH has the potential to considerably improve the nutritional status of patients with chronic kidney disease. This should reduce the notoriously high morbidity of these patients and may even postpone the need for dialysis." said Dr. Halvor Jaeger, Chief Executive Officer of LAB International.
Conference call information:
LAB will host a conference call at 10:00 am, on Thursday July 12, 2007. Interested parties may also access the conference call by webcast at www.labinc.ca.
The telephone numbers to access the conference call are 416-644-3416 or 1-800-732-6179. A replay of the call will be available until Thursday July 19, 2007. The telephone numbers to access the replay are 416-640-1917 and 1-877-289-8525 with code number 21240409#.
About Malnutrition in chronic renal failure (CRF)
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 years as the kidney structures are slowly damaged. Advanced CRF is characterized by anorexia, malnutrition, wasting, latent inflammation, accelerated atherosclerosis and a state of resistance to multiple endogenous hormones. Resistance to endogenous growth hormone is believed to contribute to tissue catabolism, but can be overcome by administration of exogenous growth hormone at pharmacological doses. Administration of LAB GHRH may stimulate endogenous growth hormone release sufficiently to reverse loss of muscle mass particularly in pre-end stage CRF patients, in whom resistance mechanisms are not as marked yet while many patients are already malnourished.
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 without significant adverse events.
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.
Ticker Symbol: (Toronto:LAB.)
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Posted: July 2007