Prolor Biotech Inc. (AMEX: PBTH) said today 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.
Prolor's hGH-CTP is currently in a Phase II clinical trial. Prolor expects to complete the Phase II trial in 2011
Ness Ziona-based Prolor develops improved versions of existing medications. Its modifications allow medications to be taken less frequently, but with the same effectiveness, or to be taken at lower dosages.
Prolor CEO Dr. Abraham Havron said, "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. 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.
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 US. The orphan drug designation provides for seven years of market exclusivity, and regulatory support.
Prolor shares jumped 10.3% in New York by late morning.
Published by Globes [online], Israel business news - www.globes-online.com - on October 5, 2010
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