EntreMed initiates Phase II study in ovarian and endometrial cancer

The primary objective of this Phase II study, which will be conducted at multiple sites in Canada, 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.

Carolyn Sidor, vice president and chief medical officer of EntreMed, said: “We now have five clinical trials underway to test the safety and efficacy of MKC- 1 in solid and hematological cancers, including two clinical development programs in Canada. We expect to invest in further clinical trials during 2008 to test the extent of MKC-1’s clinical utility in multiple tumor types.”