Drug development company Prolor Biotech Inc. (Bulletin Board: PBTH) today reported positive results from the Phase I clinical trial of its longer-acting version of human growth hormone (hGH-CTP), meeting all safety and tolerability endpoints. The study examined the drug's potential durability (half-life), biological efficacy, and its safety and tolerability.
The trial includes 24 healthy adults who receive one of three doses of hGH-CTP (4mg, 7mg, or 21mg) or a placebo. The potential clinical efficacy of the drug was assessed by measuring the extent to which it induced insulin-like growth factor-1 (IGF-1) in the subjects. This biomarker is the clinically accepted primary indicator of hGH biological activity and is used by endocrinologists to optimize dosing for hGH-deficient adults. Based on this measure, the study results suggest that the daily injections required by patients using conventional hGH could potentially be replaced with just two monthly injections of hGH-CTP.
Prolor CEO Dr. Avri Havron said, “Our hGH-CTP appears to be a safe and highly potent version of commercially available human growth hormone. Replacing the daily injections required by current hGH users with just two injections per month could dramatically improve the quality of life for patients receiving growth hormone therapy. Based on these Phase I results, we anticipate moving forward rapidly with the planning and execution of a Phase II study of hGH-CTP."
Prolor's share closed at $3.59 on Wall Street yesterday. The share has risen 250% over the past month.
Published by Globes [online], Israel business news - www.globes-online.com - on February 2, 2010
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