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Oncoscience AG, cleared for Phase III trial in Germany with nimotuzumab - Phase II results presented at the 27th Annual German Cancer Conference -
Attention Business/Health Editors:
YM BioSciences Inc. the cancer product development company, today announced that its partner, Oncoscience AG, 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. It is anticipated that marketing authorization subsequent to a successful trial would be sought under the EMEA centralized procedure.
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. Clinical sites will be located in Germany, Italy, Belarus and Russia and it is anticipated that recruitment could be completed within approximately 12 months after the start of patient enrolment. Based on a historical median survival for this form of cancer of approximately 8.5 months, the trial could be completed in the second quarter of 2007.
Additional data from the 40 patient Phase II trial conducted by Oncoscience AG were presented at the 27th Annual German Cancer Conference in Berlin on March 25th, 2006. The study reported 8 out of 40 patients were evaluable for response after consolidation therapy and showed three partial responses (PR), one Stable Disease (SD) and four progressive disease (PD) in week 21. Eight patients with consolidation therapy were free of progression for a median of 4.6 months (1.9-14.5 months). Eight children out of the 40 recruited into the trial were still surviving as of March 25th (2.9-20.6) months. Non-responders to treatment had a median survival of 1.1 months. No severe side effects and no rash, diarrhea or conjunctivitis related to the study medication were observed.
YM BioSciences has previously announced that it and its majority owned subsidiary, CIMYM Inc., propose to file for authorization to conduct a Phase III trial in North America following a clearance for such a trial in Germany. In addition YM proposes to pursue the clinical development of nimotuzumab in adult glioma as well as the current target of Non-Small Cell Lung Cancer. YM´s licensor, CIMAB SA and its parent, the Center for Molecular Immunology, are conducting trials with nimotuzumab in glioma, breast, esophageal, cervical, prostate and head and neck cancer.
Data from trials with nimotuzumab will be presented by Oncoscience AG in two separate posters: at the AACR meeting in Washington, DC on April 04, 2006 in the late breaking news poster session and at the ASCO meeting in Atlanta, Georgia on June 05, 2006. YM will also have results disclosed from a pharmacodynamic/pharmacokinetic study of nimotuzumab conducted by the University of Toronto at the ASCO meeting.