Prolor reports positive results in growth hormone pilot study

Prolor Biotech Inc. (AMEX: PBTH; TASE: PBTH) today announced positive results in a post-Phase II clinical trial of its long-acting human growth hormone (hGH-CTP) in adults. The study found that two injections of hGH-CTP per month have the potential to replace 30 consecutive daily injections of currently marketed human growth hormone.

The experimental pilot study included 12 patients who switched from daily injections of conventional hGH to a regimen of just two injections of hGH-CTP over a period of 30 days. Patient IGF-1 levels, a well-accepted biomarker for assessing the activity of growth hormone therapy, were tracked in the study and served as a measure of efficacy.

Prolor CEO Dr. Avri Havron said, "We believe that the findings from this experiential study are very promising for adult patients in need of growth hormone therapyThe Phase II results we reported last year showed that hGH-CTP can potentially provide a safe and effective new therapeutic option for adults with growth hormone deficiency when injected once-weekly, versus the daily injections of conventional hGH that are currently required. The results from this new pilot study indicate that hGH-CTP may be able to achieve an even better administration regimen - requiring injections just twice per month. This is encouraging news for growth hormone deficient patients who would like to minimize their injection regimen."

Havron continued, "We believe that these results demonstrate significant potential, especially in view of the limitations of this pilot study. First, the study duration was only 30 days, thus not allowing sufficient time for patients to adjust fully to the new injection regimen. Second, patients received only 15% or 50% of their regular cumulative hGH dose. Third, the patients did not go through the dose titration procedure that physicians usually employ to optimize hGH dosing. Despite this, there was a clear correlation between dose and IGF-1 response, and patients receiving the 50% dose showed promising IGF-1 response to the twice-monthly hGH-CTP injection regimen. We look forward to further study of the twice-monthly regimen while we also advance our ongoing clinical program for hGH-CTP administered once-weekly."

Prolor's share price has risen almost 50% since January 1. The share price rose 2.9% today, before the TASE temporarily suspended trading in the share, to NIS 23.92, and it rose 4.1% in premarket trading on the American Stock Exchange today to $6.41, giving a market cap of $348 million.

Published by Globes [online], Israel business news - www.globes-online.com - on January 18, 2012