Prolor Biotech (AMEX:PBTH) ticked higher Tuesday after reporting that its longer-acting version of the human growth hormone has been granted orphan drug designation by the US Food and Drug Administration for the treatment of growth hormone deficiency in both adults and children.
The treatment, called hGH-CTP, is currently in a phase II clinical trial that is testing the drug’s affect when injected weekly or twice a month in patients with growth hormone deficiency who currently receive daily injections of growth hormone.
The Israel-based company is seeking to develop the treatment so that it can be taken as minimally as possible, as opposed to multiple times per week required by current growth hormone regimens.
“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 Prolor CEO Dr. Abraham Havron.
Prolor expects to complete the second phase trial sometime next year.
The orphan designation targets drugs that treat rare disease, or fewer than 200,000 Americans.
It provides treatments with fast-tracked FDA approval, seven years of market exclusivity once it receives marketing approval, grant funding and tax benefits.