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YM BioSciences Reports Fiscal First Quarter 2011 Operational and Financial Results
Date:11/11/2010

said Mr. David Allan, Chairman and CEO of YM BioSciences. "We look forward to the American Society of Hematology (ASH) meeting being held in early December 2010, where we expect that detailed initial clinical data from the Phase I and early Phase II portion of the study will be presented. More advanced data from the Phase II portion of the study are anticipated in mid-2011. We remain on track to advance CYT387 towards an NDA-enabling study, potentially in the latter half of 2011, and we are also reviewing opportunities for the compound in the numerous other indications in which evidence of activity has been shown with this family of molecules." Highlights from the first quarter:CYT387:

  • Mayo Clinic concluded dose-escalation in the Phase I portion of the Phase I/II clinical trial of CYT387 in patients with myelofibrosis, a chronic debilitating condition where the patient's bone marrow is replaced by scar tissue. In total, 21 patients were treated in Phase I, with no voluntary withdrawals reported. The Chair of the trial announced that CYT387 showed significant activity in reducing spleen size and controlling constitutional symptoms in these patients. To date, 41 patients have been enrolled into the Phase II tranche bringing the total number in the study to 62. Given the favorable biological activity and safety data, the Company intends to expand enrolment for the trial up to 120 patients and include centers in the US, Canada and Australia, subject to regulatory approval.

  • CYT387 was granted Orphan Drug Designation by the US FDA in September.

  • Preclinical results for CYT387 were presented demonstrating that it possesses an excellent enzymatic potency and selectivity profile which may provide significant clinical advantages. The results were presented at the European School of Haematology International (ESH) International Conference on Myeloproliferative Neoplasms.

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