PROLOR's Phase II drug candidate gets Orphan Drug Designation from FDA Print
By BioMedReports.Com   
Tuesday, 05 October 2010 00:00
PROLOR Biotech, Inc. (NYSE Amex:PBTH) has announced that the FDA has granted orphan drug designation to PROLOR's longer-acting version of human growth hormone for the treatment of growth hormone deficiency.  The drug, known as 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. PROLOR expects to complete the Phase II trial in 2011.

The 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 U.S.  In addtion, the orphan drug designation provides the Company seven years of market exclusivity, reduction in regulatory fees, certain tax credits and additional regulatory support for R&D initiatives.

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