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Akela Pharma announces final positive results from its growth hormone releasing hormone (GHRH) Phase II trial
Date:11/12/2007

http://www.akelapharma.com Toronto Stock Exchange Symbol: AKL

MONTREAL, Nov. 12 /PRNewswire-FirstCall/ - Akela Pharma Inc. (TSX: "AKL"), a drug development company focused on developing therapies for the inhalation and pain markets, today announced positive final results from its pilot GHRH Phase II study. Within only 4 weeks of treatment, Akela 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 and bioelectrical impedance (BIA). As we reported in July 2007, the study did not reveal significant changes between treatment groups in total body protein turnover. Total body protein turnover, as measured by 13C leucine kinetics, was normal in both treatment groups already at baseline, most probably reflecting adaptative changes of metabolic balance in the chronic disease state.

ABOUT THE STUDY:

The study was conducted at 3 European sites. It was designed to evaluate the clinical potential of GHRH analogue (AKL-0707) administration in improving body composition, nutritional and metabolic parameters in malnourished patients with stage IV or pre-dialytic stage V chronic kidney disease (CKD). Malnutrition was defined by either serum albumin <40 g/l, body mass index (BMI) <23, or a greater than 5% loss of body weight in the last 6 months.

Twenty-eight patients were randomized to either GHRH analogue subcutaneously (sc.) (13 patients) or placebo sc. (15 patients). Twenty-six subjects completed the study as planned. The mean age was 61.8 and 63.4 in the GHRH analogue and placebo groups, respectively. The treatment was administered twice daily (AM & PM) for
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SOURCE Akela Pharma Inc.
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