ONCOSCIENCE CLEARED FOR PHASE III TRIAL IN GERMANY
Oncoscience has been cleared by the German regulatory authority for biological products, the Paul Ehrlich Institute, to initiate a Phase III trial of nimotuzumab in combination with radiation in children with inoperable pontine (brain stem) glioma. The clinical trial was also reviewed with the EMEA and is designed as a prospectively registrable study on the basis of a single-arm trial because of the absence of treatment options for children suffering from pontine glioma.
The trial is a single-arm study in which 40 children with inoperable pontine glioma will be treated with radiation concomitant with nimotuzumab. The primary clinical endpoints in the trial will be progression-free survival at 3, 6, 12 and 24 months with median survival as secondary endpoint.