EntreMed Presents Initial Clinical Results for...(nd Drug Administration (FDA) granted orp...),Health

Date:2/9/2009

nd Drug Administration (FDA) granted orphan drug designation for ENMD-2076 for the treatment of multiple myeloma. The FDA accepted the Company's application based on review of data from preclinical studies. A Phase 1 study with ENMD-2076 in multiple myeloma is currently underway. Orphan drug is a designation by the Food and Drug Administration indicating a therapy developed to treat diseases that affect fewer than 200,000 persons in the United States. Sponsors of drugs granted orphan designation qualify for tax credit and marketing exclusivity incentives of the Orphan Drug Act.

EntreMed Vice President and Chief Medical Officer, Carolyn F. Sidor, M.D., M.B.A., commented, "The clinical program for ENMD-2076 is expanding. We have both a U.S. IND and a Canadian CTA in place, multiple Phase 1 studies underway, a Phase 1 study for leukemia is being planned; and now orphan drug designation in multiple myeloma. The CTA for ENMD-2076 represents a significant step forward for our Aurora/angiogenic kinase inhibitor program. With our ongoing trial in solid tumors, coupled with the initiation of the previously announced multiple myeloma study and the expected commencement of the leukemia study, the program covers a spectrum of potential indications. The staggered start of the Phase 1 multiple myeloma and leukemia studies will allow us to start treatment at a higher dose, thereby reducing the number of dose escalations required to determine a dose for subsequent Phase 2 hematological studies."

About ENMD-2076

ENMD-2076 is an orally-active, Aurora A/angiogenic kinase inhibitor with a unique kinase selectivity profile and multiple mechanisms of action. Preclinical studies with ENMD-2076 demonstrate significant antitumor activity, including tumor regression, in multiple solid and hematological malignancies. ENMD-2076 has been shown to inhibit a distinct profile of angiogenic tyrosine kinase targets in addition to Auror
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SOURCE EntreMed, Inc. Copyright©2009 PR Newswire. All rights reserved

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