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12-08-2010: YM BioSciences Inc. announced that the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the Company's highly-selective JAK1/2 inhibitor, CYT387, for the treatment of myelofibrosis, a chronic debilitating unmet medical need, in which a patient's bone marrow is replaced by scar tissue, and for which treatment options are limited or unsatisfactory.
"CYT387 is a potent, oral JAK1/2 inhibitor that has been demonstrating very favorable biological activity data in our ongoing Phase I/II trial in myelofibrosis and the granting of Orphan Drug Designation is a key regulatory milestone for our CYT387 clinical development program," said Dr. Nick Glover, COO of YM BioSciences. "This event provides us with further support for our expanding commitment to this promising drug as we continue to broaden our investment in our CYT387 development program while concentrating on advancing the molecule towards an NDA-enabling study in myelofibrosis."
The compound is currently being investigated in an oral Phase I/II clinical study in myelofibrosis patients at Mayo Clinic, Rochester, New York with Dr. Ayalew Tefferi, Professor, Hematology as Study Chair. The company intends to expand the present program up to 120 patients at a maximum of six centers in the U.S., Canada and Australia, subject to regulatory approval.
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YM BioSciences granted Orphan Drug Designation for CYT387
YM BioSciences Inc. announced that the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the Company's highly-selective JAK1/2 inhibitor, CYT387, for the treatment of myelofibrosis, a chronic debilitating unmet medica ... more
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U. S. Food and Drug Administration (FDA)
FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. FDA is also responsible for advancing the public hea ... more
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