| Add to balance / Manage account | User: | Log out |
| Prospect News home > News index > List of issuers E > Headlines for EntreMed Inc. > News item |
EntreMed: FDA approves Investigational New Drug Application for cancer fighter ENMD-1198
By E. Janene Geiss
Philadelphia, Nov. 22 - EntreMed, Inc. announced Tuesday that the U.S. Food and Drug Administration has accepted its Investigational New Drug Application for ENMD-1198, a novel tubulin binding agent for which EntreMed intends to pursue clinical development.
The company said it plans to enter into phase 1 oncology clinical studies with the compound in 2006, according to a company news release.
ENMD-1198 is a new chemical entity based on a modified chemical structure of 2ME2 and is designed to increase antitumor and antiangiogenic properties and improve metabolism.
ENMD-1198 is characterized by its multiple mechanisms of action, which include inducing apoptosis, binding microtubules and inhibiting HIF-1alpha. HIF-1alpha is over-expressed in more than 70% of human tumors and its over-expression correlates with tumor aggressiveness, metastases and poor prognosis, officials said.
Preclinical studies identified ENMD-1198 as an orally active, microtubule disrupting agent that leads to arrest of cell division and apoptosis in tumor cells. And ENMD-1198 exerts antiangiogenic activity that contributes to its overall antitumor effects, officials said.
The company said along with the initiation of phase 1 oncology studies for ENMD-1198 in 2006, phase 2 studies of its lead drug candidate 2ME2 are planned.
"This means EntreMed will have two drug candidates with antitumor and antiangiogenic properties in the clinic in 2006. Both clinical stage drug candidates, Panzem NCD and ENMD-1198, are multi-mechanism agents that inhibit HIF-1alpha, but with different safety and activity profiles. As such, we have a clear path to developing both compounds," EntreMed vice president and chief medical officer Carolyn F. Sidor said in the release.
EntreMed is a Rockville, Md., clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases.
© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere.
For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.