Multi-Center Clinical Trial to be Conducted in Canada
ROCKVILLE, Md., Jan. 23 /PRNewswire-FirstCall/ -- EntreMed, Inc. (Nasdaq: ENMD), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, today announced the commencement of a Phase 2 study with its novel cell cycle inhibitor, MKC-1, in recurrent or resistant epithelial ovarian cancer and advanced endometrial cancer patients. The study will be conducted at multiple sites in Canada with Dr. Amit Oza, Senior Staff Physician and Associate Professor of Medicine, Princess Margaret Hospital, University of Toronto, serving as the principal investigator.
The primary objective of this Phase 2 study will be to determine the antitumor activity of MKC-1 administered orally as a single agent in platinum or taxane refractory ovarian and endometrial cancer patients. In addition, safety, response duration in patients with an objective response, and progression free survival (PFS) will also be assessed. The study will be a two arm parallel group design with each group having two stages.
MKC-1 is a novel, orally-active cell cycle inhibitor with in vitro and in vivo efficacy against a broad range of human solid tumor cell lines, including multi-drug resistant cell lines. Data from previous studies with MKC-1 demonstrate broad-acting antitumor effects, showing tumor growth inhibition or regression in multiple preclinical models, including paclitaxel-resistant models.
MKC-1 has been shown to inhibit mitotic spindle formation, prevent
chromosome segregation in th
|SOURCE EntreMed, Inc.|
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