PROLOR Biotech initiates Phase I clinical trial of its human growth hormone drug candidate

Sep 21 2009

PROLOR Biotech, Inc. (OTC Bulletin Board: PBTH) formerly Modigene Inc., today announced the initiation of a Phase I clinical trial of its long-acting human growth hormone drug candidate hGH-CTP.

hGH-CTP is being developed to provide growth hormone deficient adults and children with the option to replace the multiple injections per week that are currently required with a once-weekly or bi-monthly injection. The initiation of the trial follows a successful safety and immunogenicity study of hGH-CTP in primates and regulatory approvals by the IRB committee of the Tel-Aviv Medical Center and the Israeli Ministry of Health.

The Phase I trial is a randomized, double-blinded, placebo-controlled, single-dose, dose-escalating study to evaluate the safety, tolerability, and pharmacokinetic and pharmacodynamic properties of hGH-CTP in 24 healthy volunteers. It will be conducted at the Early-Phase Clinical Pharmacology Unit located at the Tel-Aviv Medical Center.

"The initiation of a Phase I clinical trial of our long-acting hGH-CTP represents an important milestone for PROLOR," said Dr. Avri Havron, CEO of PROLOR. "We were delighted with the results of our hGH-CTP studies in primates, which showed that hGH-CTP had an excellent half-life and biological activity and was safe at all doses tested without any signs of immunogenicity. We are now eager to obtain data on its bioactivity in humans."

Dr. Havron continued, "This trial is being conducted at the Early-Phase Clinical Pharmacology Unit at the Tel-Aviv Sourasky Medical Center, a top-notch facility that has a successful track record of conducting more than 250 clinical studies for leading global pharmaceutical and biotech companies in a variety of clinical areas. We look forward to completing the Phase I trial so that we can move ahead with the further clinical development of hGH-CTP."