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YM BioSciences' partner cleared for phase 3 trial in Germany of nimotuzumab for cancer
By Lisa Kerner
Erie, Pa., March 28 - YM BioSciences, Inc. said its partner, Oncoscience AG, received approval from the German regulatory authority for biological products (the Paul Ehrlich Institute) to begin a phase 3 trial of nimotuzumab in combination with radiation in children with inoperable pontine (brain stem) glioma.
The trial, a single-arm study of 40 children, will be held at clinical sites in Germany, Italy, Belarus and Russia.
Primary clinical endpoints in the trial will be progression-free survival at three, six, 12 and 24 months, with a secondary endpoint of median survival.
The trial could be completed in the second quarter of 2007, according to a company news release.
Data from Oncoscience's 40-patient phase 2 trial showed that eight out of 40 patients were evaluable for response after consolidation therapy and showed three partial responses, one stable disease and four progressive disease in week 21. No severe side effects, rash, diarrhea or conjunctivitis were observed, the company said.
YM said it plans to pursue the clinical development of nimotuzumab in adult glioma as well as the current target of non-small cell lung cancer.
In addition, 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.
Based in Wedel, Germany, Oncoscience is a biotechnology company focused on oncology, organ transplantation and tumor tissue banking, including research in genomics/proteomics.
YM is a cancer-product development company located in Mississauga, Ont.
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