YM BioSciences USA cleared by US FDA to initiate Phase II clinical trial of nimotuzumab in children with brain cancer
YM BioSciences Inc. announced that its wholly-owned US subsidiary, YM BioSciences USA Inc. 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 trial design is based on a previous trial conducted in Germany. In that trial, which was the subject for an oral presentation at ASCO 2007, eight of 21 children with recurrent DIPG had a clinical benefit from treatment with nimotuzumab as monotherapy - one Partial Response (PR) and seven Stable Disease (SD) were reported in 21 patients, at the end of the induction phase at the eighth week. Those eight patients continued on maintenance therapy and, at week 21, three patients were declared PR and one was evaluated SD. No reports of OR in this patient population has, to the knowledge of the Company, been previously reported.
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 from initiation. The principal investigatory site is the Hospital for Sick Children in Toronto, Canada where Drs. Eric Bouffet, Sylvain Baruchel, and Ute Bartels lead the international program. The US investigatory sites at which the trial will be conducted include leading pediatric neuro-oncology centers that are members of the "POETIC" consortium (Pediatric Oncology Experimental Therapeutics International Consortium). Members of POETIC include Vanderbilt Children's Hospital/Vanderbilt-Ingram Cancer Center, M.D. Anderson Cancer Center, Memorial Sloan-Kettering Cancer Center, the Sidney Kimmel Cancer Center at Johns Hopkins, Children's Healthcare of Atlanta at Egleston, the Children's Hospital at the University of Colorado and the University of Florida and Alberta's Children's Hospital in Calgary. In addition, the University of Rochester Medical Center and the New York University Medical Center will also be included in the trial.
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