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news.Prolor Biotech, a clinical stage biopharmaceutical company, has received the Paediatric Committee of the European Medicines Agency (EMA) acceptance to review its paediatric investigation plan (PIP) for clinical development of its human growth hormone (hGH-CTP).
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Currently, the company is developing hGH-CTP in Phase II trial as a treatment for growth harmone deficiency in children.
Earlier, Prolor has released interim results from a Phase II trial evaluating hGH-CTP in adults which demonstrated that a single weekly injection of hGH-CTP, even when administered at relatively low doses, has the potential to replace seven consecutive daily injections of currently marketed human growth hormone.
Prolor president Shai Novik said as they advance hGH-CTP towards Phase III, they are committed to proactively addressing all of the requirements for ensuring the rapid progress of the clinical and regulatory program needed for approval of hGH-CTP in growth hormone-deficient adults.
"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 hGH requiring fewer injections is expected to have large clinical and commercial potential," Novik said.