er expanded its clinical development efforts for ENMD-2076 and has commenced a Phase 1 study in patients with relapsed or refractory leukemia. The study will be conducted at the Princess Margaret Hospital in Toronto, Ontario and Karen Yee, M.D., will serve as Principal Investigator. Although the primary endpoints of the study include defining the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of ENMD-2076 administered orally in patients with relapsed or refractory leukemia, the study will also evaluate pharmacodynamic effects of ENMD-2076 by collaborating with Dr. David Hedley, Department of Molecular Oncology, Ontario Cancer Institute (OCI).
Dr. Mark R. Bray, EntreMed Vice President, Research commented, "We are very excited to be working with Dr. Hedley and his staff, who have considerable experience in evaluating the mechanistic effects of kinase inhibitors like ENMD-2076 in cancer patients. The close proximity of EntreMed scientific personnel based in Toronto to our clinical collaborators at the OCI will facilitate our ability to obtain the maximum value from this study and its correlative components."
In addition, the U.S. Food and Drug Administration (FDA) granted orphan drug designation for ENMD-2076 for the treatment of ovarian cancer. Several ovarian cancer patients participated in the ENMD-2076 Phase 1 study in solid tumors and will be included in the data presentations at ASCO. Orphan drug is a designation by the Food and Drug Administration indicating a therapy developed to treat diseases that affect fewer than 200,000 persons in the United States. Sponsors of drugs granted orphan designation qualify for tax credit and marketing exclusivity incentives of the Orphan Drug Act. Previously EntreMed had received orphan drug designation for ENMD-2076 for multiple myeloma.
EntreMed Vice President and Chief Medical Officer, Carolyn F. Sidor, M.D., M.B.A., commented, "The clinical developmentPage: 1 2 3 4 5 Related biology technology :1
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