Prolor Biotech Inc. (AMEX: PBTH; TASE: PBTH) today announced that the European Medicines Agency's (EMEA) Pediatric Committee has accepted the company's investigation plan for a clinical trial of its long-acting human growth hormone (hGH-CTP) in children in Europe.
Prolor said that, following promising efficacy and safety interim results in its ongoing Phase II trial of hGH-CTP in growth hormone-deficient adults, it is developing the hormone for the treatment of growth hormone-deficient children. The company announced the clinical trial's positive interim efficacy results in April.
Prolor president Shai Novik said, "As we advance hGH-CTP towards Phase III, we are committed to proactively addressing all of the requirements for ensuring the rapid progress of the clinical and regulatory program needed for approval of hGH-CTP in growth hormone-deficient adults."
Prolor's share price rose 1.8% in premarket trading on the American Stock Exchange today to $4.54, giving a market cap of $250 million, but fell 2.2% by mid-afternoon on the TASE to NIS 15.43.
Published by Globes [online], Israel business news - www.globes-online.com - on June 20, 2011
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