Prolor Biotech, Inc, a company developing next generation biobetter therapeutic proteins, announced that the US Food and Drug Administration (FDA) has granted orphan drug designation to hGH-CTP, Prolor’s longer-acting version of human growth hormone for the treatment of growth hormone deficiency. hGH-CTP is currently in a phase-II clinical trial.
“By reducing the frequency of injections from as many as seven per week to just one injection every one to two weeks, our longer-acting human growth hormone has the potential to improve the lives of the many individuals with growth hormone deficiency,” said Dr Abraham Havron, CEO of Prolor. “We are therefore very pleased to receive this orphan drug designation, which has been broadly defined for the treatment of growth hormone deficiency in both adults and children.”
Prolor is developing hGH-CTP to provide growth hormone-deficient adults and children with therapy that requires only once-weekly or bi-monthly injections, rather than the multiple injections per week required by current growth hormone regimens. Results from a successful phase-I trial showed that hGH-CTP met all safety and tolerability endpoints and could potentially be effective when injected just twice per month.
The hGH-CTP phase-II trial is a randomized, open-label, dose-finding study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic properties of hGH-CTP injected either weekly or twice-monthly in patients with growth hormone deficiency who currently receive daily injections of growth hormone. Prolor expects to complete the phase-II trial in 2011.
FDA's Orphan Drug Act of 1983 was designed to encourage the development of products that demonstrate promise for the diagnosis, prevention and/or treatment of life-threatening or very serious conditions that are rare and affect 200,000 persons or less in the US. The orphan drug designation provides for seven years of market exclusivity, reduction in regulatory fees, certain tax credits and additional regulatory support for R&D initiatives.
Prolor Biotech is a biopharmaceutical company applying unique technologies, including its patented CTP technology, primarily to develop longer-acting, biobetter, proprietary versions of already-approved therapeutic proteins that currently generate billions of dollars in annual global sales.