Oncoscience and YM BioSciences Announce Completion of Patient Enrollment in Phase III Brain Cancer Trial of Nimotuzumab
YM BioSciences Inc. announced that Oncoscience AG, its European partner for the development of the humanized EGFR-targeting monoclonal antibody, nimotuzumab, has recruited the 40th and final patient in its international phase III trial combining nimotuzumab with radiation for the treatment of children and adolescents suffering from diffuse intrinsic pontine glioma (DIPG). DIPG is an inoperable form of brain cancer for which treatment options are severely limited. The Phase III trial is being conducted by an international group of paediatric oncologists under the lead of principal investigator Professor Udo Bode at the University of Bonn, Germany. The primary end-point of the trial is progression-free survival with overall survival as a secondary endpoint. Nimotuzumab has been designated an Orphan Drug by the EMEA.
Positive European data from a completed second line 47-patient Phase II nimotuzumab monotherapy trial in recurrent pediatric glioma were most recently summarized in an oral presentation at ASCO 2007. The clinical benefit rate of 38% after 8 weeks, including partial responses and stable disease, for patients with recurrent DIPG in this study represents a unique observation in these end-stage patients and has generated considerable interest.
Nimotuzumab is a humanized monoclonal antibody that targets the epidermal growth factor receptor (EGFR). To date nimotuzumab has been administered to approximately 900 patients in more than a dozen clinical trials and on a compassionate basis. It has been approved in several countries and is being provided on a compassionate basis in certain countries including Canada, Germany, Australia and Japan. The drug continues to demonstrate a significantly more benign side-effect profile compared to all the other EGFR-targeting antibodies and small molecules targeting the EGF tyrosine kinase signalling pathway. The absence of any cases of severe rash to date and the very rare instances of any of the other debilitating side effects holds the prospect for nimotuzumab to become best-in-class for this important family of EGFR-targeting agents.
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Topic world Antibodies
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