PROLOR Biotech, Inc. announced that its pediatric investigation plan for clinical development of its long-acting human growth hormone (hGH-CTP) has been accepted for review by the Pediatric Committee of the European Medicines Agency (EMA). Following promising efficacy and safety interim results in its ongoing Phase 2 trial of hGH-CTP in growth hormone-deficient adults, PROLOR is now actively pursuing development of hGH-CTP for the treatment of growth hormone-deficient children.
Last April, PROLOR announced positive interim efficacy results from its Phase 2 trial of hGH-CTP in adults. The interim efficacy data showed that a single weekly injection of hGH-CTP, even when administered at relatively low doses, has the potential to replace seven consecutive daily injections of currently marketed human growth hormone. These positive interim data followed PROLOR’s announcement in February that hGH-CTP has demonstrated a good safety profile in the Phase 2 trial, as confirmed in a review of interim data by the independent Data and Safety Monitoring Board.
In the European Union, a company submitting a first-time Marketing Authorization Application (MAA) to the EMA for a new drug product must have in place an approved pediatric investigation plan (PIP) detailing both the timelines for development and special measures that will be taken when developing the drug for children, even if the first submission is for use in adult populations. If an approved PIP is not in place, the EMA will not approve the MAA for use in adults.
“As we advance hGH-CTP towards Phase 3, 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,” said Shai Novik, president of PROLOR. “The EMA’s acceptance of our PIP for review is a positive development for the current clinical program and is also an important early milestone in our plans to develop hGH-CTP for growth hormone-deficient children, a population in which a longer-acting hGH requiring fewer injections is expected to have large clinical and commercial potential.”
Date: June 20, 2011
Source: PROLOR Biotech, Inc.
Filed Under: Drug Discovery