EntreMed fixes dosing levels for Panzem NCD to treat cancer following phase 1b studies

New York, Nov. 16 - Entremed, Inc. said it has determined a dose and schedule of administration for its Panzem NCD treatment for patients with advanced cancer.

The levels were fixed following two phase 1b studies. Data from the trials was presented by principal investigators George Wilding, director of the University of Wisconsin Comprehensive Cancer Center, and Christopher J. Sweeney, co-director of the Experimental and Developmental Therapeutics Program at Indiana University Cancer Center, during a poster session at the combined AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics being held this week in Philadelphia.

"The primary objectives for these trials have been met, an optimal dose has been determined, and we have a schedule for dosing Panzem NCD," said Carolyn F. Sidor, EntreMed's vice president and chief medical officer, in a news release. "In addition, 2ME2 blood concentrations that are associated with significant preclinical antitumor activity can now be sustained in cancer patients following oral administration with Panzem NCD." 2ME2 or 2-methoxyestradiol is the chemical name for Panzem.

She added that plans for multiple phase 2 studies are "currently underway."

The data demonstrated that significant therapeutic activity in three distinct tumor models was achieved by maintaining 2ME2 blood levels in the low ng/mL range over a 24 hour dosing period, EntreMed said. The activity was independent of the route of administration provided that sustained blood levels of 2ME2 were achieved.

The blood concentration range of 2ME2 required for significant tumor response was approximately 100-fold lower than effective in vitro concentrations, and may be attributable to 2ME2's multiple mechanism of action, as well as its independent actions on both the tumor cell and vascular compartments of a cancer, the company added.

EntreMed is a Rockville, Md., pharmaceutical company developing therapeutic candidates primarily for the treatment of cancer and inflammation. Panzem (2-methoxyestradiol or 2ME2) is its lead drug candidate.

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