DSMB RECOMMENDS THAT ENTREMED CONTINUE BREAST CANCER STUDY

EntreMed announced a favorable review of MKC-1 safety data by an independent data safety monitoring board (DSMB). The review was undertaken to assess the safety of MKC-1 in a Phase II multicenter clinical trial in patients with advanced or metastatic breast cancer who have failed conventional therapies.

The DSMB concluded that the apparent risk, based on the current safety data review for MKC-1, was appropriate for the population under study. The DSMB also felt that the study did not require any modification, and that the Phase II study in patients with metastatic breast cancer should continue as currently designed. The study is being conducted at multiple centers across the U.S. and is evaluating the safety and efficacy of MKC-1 in metastatic breast cancer patients who have failed therapy with anthracylines and taxanes.

EntreMed also announced that it recently completed the purchase of all remaining bulk quantities of the active pharmaceutical ingredient for MKC-1 from Roche. EntreMed has a worldwide exclusive license from Roche to develop and commercialize MKC-1. In addition to the clinical trial in metastatic breast cancer, MKC-1 is currently in Phase I and II clinical studies in patients with non-small-cell lung cancer and hematological malignancies.

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 multidrug-resistant cell lines. In previous studies, MKC-1 demonstrated 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 the M-phase (mitosis) of the cell cycle, and induce apoptosis. These effects are consistent with mechanisms resulting from MKC-1 binding to multiple intracellular targets, including tubulin and the importin-beta proteins. The importin-beta family of proteins plays a critical role in nuclear transport and cell division.