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news.YM BioSciences Inc has been advised by its European partner, Oncoscience AG, that a phase II trial evaluating TheraCIM h-R3 as a monotherapy in children with brain cancer achieved a response rate of 35.3%.
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Six of the 17 children who were fully evaluable at the time of the conference were reported to have demonstrated either stable disease or a partial response to the EGF receptor monoclonal antibody TheraCIM h-R3 (nimotuzumab, known as Theraloc in Europe).
Of the six, four were identified by investigators to have been suffering from pontine glioma (diffuse intrinsic brain stem glioma) – a form of the disease that is particularly aggressive and generally untreatable.
No skin toxicity or allergic reactions were reported, consistent with all the previous trials conducted with TheraCIM h-R3.
The positive results of the trial permit Oncoscience to apply for an investigational new drug application (IND) to conduct a pivotal trial testing the combination of the h-R3 antibody with radiation against radiation alone for the first line treatment of pediatric glioma.
If approved, the pivotal trial could start in Q2 2005, and could include up to 100 patients.