The four-month extended Phase II clinical trial of its long-acting human growth hormone (validates the earlier results of the one-month clinical trial.
Prolor Biotech Inc. (AMEX: PBTH; TASE: PBTH) today reported that the four-month extended Phase II clinical trial of its long-acting human growth hormone (hGH-CTP) validates the earlier results of the clinical trial, in which hGH-CTP was injected in growth hormone deficient adults once a week over one month. The new study reaffirmed that once a week dosages can replace even consecutive daily injections of currently marketed human growth hormone.
The four-month extended study enrolled 42 growth hormone deficient adults (34 men and eight women) who had received a daily growth hormone therapy and who had previously participated in the Phase II trial that tested a once-weekly hGH-CTP regimen or in the pilot assessment of a twice-monthly hGH-CTP regimen.
Preliminary analysis of the extended study's data also confirmed the safety and tolerability of hGH-CTP, with no unexpected adverse events. In addition, there was no indication that high doses of hGH-CTP can induce excessive levels of insulin-like growth factor 1 (IGF-1) above the normal range. The study found that the proportion of patients receiving once-weekly injections of hGH-CTP who achieved the normal range of IGF-1 levels was comparable with the proportion of patients who received daily dosages of commercial growth hormones.
Prolor's share price rose 1.5% by mid-afternoon on the TASE following the announcement to NIS 20.13, after falling 1.9% yesterday on Nasdaq to $5.24, giving a market cap of $290 million.
Published by Globes [online], Israel business news - www.globes-online.com - on May 7, 2012
© Copyright of Globes Publisher Itonut (1983) Ltd. 2012
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