The multicenter, open-label, randomized study was designed to assess the safety and tolerability of hGH-CTP in growth hormone deficient adults.
The data demonstrated that a single weekly injection of hGH-CTP has the potential to replace seven consecutive daily injections of currently available human growth hormone (hGH).
Prolor president Shai Novik said based on these positive results, Prolor is offering patients who participated in the Phase II trial the opportunity to continue treatment with single weekly injections of hGH-CTP for an additional four months.
"Based on feedback from patients and their physicians, we expect that the majority of patients who completed the Phase II study will elect to participate in the four-month extension period, which we view as a powerful endorsement of hGH-CTP in view of the fact that those patients who elect to participate will have to undergo continued clinical monitoring requirements such as routine blood collections," Novik said.
"We expect that information from the voluntary extension period will provide additional data enabling us to further verify the anticipated doses and titration schedule of hGH-CTP for the planned Phase III trial."