YM BioSciences USA cleared by US FDA to initiate Phase II clinical trial of nimotuzumab in children with inoperable, recurrent br...( MISSISSAUGA ON Aug. 30 / YM BioSc...)

MISSISSAUGA, ON, Aug. 30 /PRNewswire-FirstCall/ - YM BioSciences Inc. (AMEX: YMI, TSX: YM, AIM: YMBA), an oncology company that identifies, develops and commercializes differentiated products for patients worldwide, today announced that its wholly-owned US subsidiary, YM BioSciences USA Inc. ("YM-USA") has been cleared by the US Food and Drug Administration (FDA) to initiate a Phase II trial investigating nimotuzumab in pediatric patients with recurrent diffuse intrinsic pontine glioma (DIPG), a form of inoperable, treatment-resistant brain cancer. Nimotuzumab is a humanized monoclonal antibody that targets the epidermal growth factor receptor (EGFR). Eight leading US pediatric clinical centers will be participating in the study. YM BioSciences previously announced that it had received a No Objection Letter from Health Canada in June 2007 to initiate this single-arm trial, which will enrol 44 patients with DIPG who will be treated with nimotuzumab as monotherapy.

This is the first occasion, to the knowledge of the Company, in which a clinical trial has been cleared by the FDA for a drug of Cuban origin. Clearance for importation of nimotuzumab into the US for this trial was authorized by a Special License issued to YM-USA by the US Treasury Department's Office of Foreign Assets Control (OFAC). Nimotuzumab has already been administered to a number of children in the US under licenses from the US Treasury Department and under single-patient INDs from the FDA.

"The clearance of this US IND by the FDA is a significant step in the development of nimotuzumab," said David Allan, Chairman and CEO of YM BioSciences. "In addition to the US investigatory sites, the global development program for nimotuzumab includes o
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