YM Bioscience USA enrolls first patient in phase II trial of Nimotuzumab in children with inoperable, recurrent brain cancer
YM BioSciences Inc. announced that its wholly-owned US subsidiary, YM BioSciences USA Inc. has enrolled the first patient in its Phase II trial investigating nimotuzumab in pediatric patients with recurrent diffuse intrinsic pontine glioma (DIPG), a form of inoperable, treatment-resistant brain cancer. The patient was treated at the M.D Anderson Cancer Center under the care of Dr. Johannes Wolff. Nimotuzumab is a humanized monoclonal antibody that targets the epidermal growth factor receptor (EGFR).
Eight leading US pediatric clinical centers and two Canadian centers will be participating in the single-arm trial, which is designed to enroll 44 patients with DIPG who will be treated with nimotuzumab as monotherapy. The primary endpoint of the current trial is Response Rate, with a target of 15%, and recruitment is expected to be completed within approximately 18 months.
Nimotuzumab in combination with radiation-containing regimens has been demonstrated to be effective in other indications for which it is already approved in certain jurisdictions. The clinical benefit of nimotuzumab as monotherapy in a range of patients refractory to all treatments was published in the proceedings at ASCO, 2007 in addition to the presentation of the pediatric results.
Nimotuzumab is a humanized monoclonal antibody that targets the epidermal growth factor receptor (EGFR). To date nimotuzumab has been administered to more than 2000 patients and evaluated in more than a dozen clinical trials. It has been approved in several countries and has been provided on a compassionate basis in a number of countries including the US, Canada, Germany, and Australia. The emerging safety data for nimotuzumab suggests a more benign side-effect profile in its trials with radiation-containing regimens compared to currently approved EGFR targeting antibodies and small molecules. To date, in patients treated with nimotuzumab, there has been no evidence of severe rash or any life-threatening adverse events. The unique safety profile for nimotuzumab holds the prospect for it to become best-in-class within this important family of EGFR-targeting agents.
Nimotuzumab has been designated an Orphan Drug by the US FDA and by the EMEA for glioma.
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Topic world Antibodies
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