EntreMed gets FDA’s nod for clinical trials of antitumor drug

ENMD-2076 is a novel, dual-acting, kinase inhibitor with potent activity against Aurora A and tyrosine kinases linked to promoting cancer and inflammatory diseases. The company claims that ENMD-2076 has demonstrated substantial, dose-dependent efficacy as a single agent in multiple xenograft models, including tumor regression in breast, colon, and leukemia models. Importantly, ENMD-2076 is an oral agent that has shown an acceptable toxicity profile in preclinical studies without cardiovascular effects.

Carolyn Sidor, vice president and chief medical officer of EntreMed, said: “Acceptance of the IND application for ENMD-2076 initiates the clinical program for our first compound that targets kinases. We plan to initiate several clinical studies with ENMD-2076 that include Phase I trials in both solid and hematological cancers in 2008.”