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PROLOR's clincial development plan accepted for review by European authorities

Published: 17:21 20 Jun 2011 BST

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Biopharmaceutical company PROLOR Biotech (AMEX:PBTH) announced Monday its clinical development plan for its long-acting human growth hormone (hGH-CTP) for children has been accepted for review by the European Medicines Agency (EMA).

A phase II trial for hGH-CTP in adults found positive outcomes, which were announced in April. Interim results showed a single injection of PROLOR's hGH-CTP each week, even in relatively low doses, had the same effect as daily doses of the currently-marketed hGH product.

In light of the positive results, PROLOR is pursuing the development of hGH-CTP for the treatment of children with a human growth hormone deficiency. A lack of this hormone in children often leads to growth failure, short stature, and delayed sexual maturity.

The long-lasting effect of PROLOR's drug is due to its CTP technology, which lengthens the drug's half-life, or the amount of time for the substance to be consumed by half in the decaying process.

Based in Nes Ziona, Israel, PROLOR must have an approved pediatric investigation plan (PIP), which details the development timeline for the product and any special measures that will be taken in developing the drug for children, before submitting a Marketing Authorization Application (MAA) to the EMA, even if the MAA is for the adult variation of the drug.

"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," said president Shai Novik.

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