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This is the first occasion, to the knowledge of the Company, in which aclinical trial has been cleared by the FDA for a drug of Cuban origin.Clearance for importation of nimotuzumab into the US for this trial wasauthorized by a Special License issued to YM-USA by the US TreasuryDepartment's Office of Foreign Assets Control (OFAC). Nimotuzumab has alreadybeen administered to a number of children in the US under licenses from the USTreasury Department and under single-patient INDs from the FDA.
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"The clearance of this US IND by the FDA is a significant step in thedevelopment of nimotuzumab," said David Allan, Chairman and CEO of YMBioSciences. "In addition to the US investigatory sites, the globaldevelopment program for nimotuzumab includes ongoing and planned clinicaltrials involving this and various other indications of cancer in Canada,Europe, Japan, Korea, Singapore, India, Argentina, and Brazil."
The trial design is based on a previous trial conducted in Germany. Inthat trial, which was the subject for an oral presentation at ASCO 2007, eightof 21 children with recurrent DIPG had a clinical benefit from treatment withnimotuzumab as monotherapy - one Partial Response (PR) and seven StableDisease (SD) were reported in 21 patients, at the end of the induction phaseat the eighth week. Those eight patients continued on maintenance therapy and,at week 21, three patients were declared PR and one was evaluated SD. Noreports 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 targetof 15%, and recruitment is expected to be completed within approximately 18months from initiation. The principal investigatory site is the Hospital forSick Children in Toronto, Canada where Drs. Eric Bouffet, Sylvain Baruchel,and Ute Bartels lead the international program. The US investigatory sites atwhich the trial will be conducted include leading pediatric neuro-oncologycenters that are members of the "POETIC" consortium (Pediatric OncologyExperimental Therapeutics International Consortium). Members of POETIC includeVanderbilt Children's Hospital/Vanderbilt-Ingram Cancer Center, M.D. AndersonCancer Center, Memorial Sloan-Kettering Cancer Center, the Sidney KimmelCancer Center at Johns Hopkins, Children's Healthcare of Atlanta at Egleston,the Children's Hospital at the University of Colorado and the University ofFlorida and Alberta's Children's Hospital in Calgary. In addition, theUniversity of Rochester Medical Center and the New York University MedicalCenter will also be included in the trial.
YM BioSciences' European partner for the development of nimotuzumab,Oncoscience AG, recently announced the enrolment of the 40th and final patientin its international Phase III trial combining nimotuzumab with radiation forthe first-line treatment of children and adolescents with newly diagnosedDIPG.
