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Biopharmaceuticals Oncology FDA

 News Release - January 3, 2008

EntreMed Announces FDA Acceptance of IND Application for Aurora Kinase/Angiogenesis Inhibitor, ENMD-2076

ROCKVILLE, Md., Jan. 3 (HSMN NewsFeed) -- EntreMed, Inc. (Nasdaq: ENMD ), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for its aurora kinase/angiogenesis inhibitor, ENMD-2076.

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. ENMD-2076 acts through multiple pathways resulting in antiproliferative activity and the inhibition of angiogenesis. 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 F. Sidor, MD, MBA, EntreMed Vice President and Chief Medical Officer commented on the IND, "Acceptance of the Investigational New Drug application for ENMD-2076 initiates the clinical program for our first compound that targets kinases. This is an exciting class of compounds with several recently approved in oncology indications. ENMD-2076 is unique in class because it not only inhibits Aurora A selectively over Aurora B, it also inhibits a number of other kinases important in the growth of tumors and, in particular, growth factor receptors critical to angiogenesis. ENMD-2076 has potent antitumor activity in multiple preclinical models including both solid tumors and hematological cancers. As such, we plan to initiate several clinical studies with ENMD-2076 that include Phase 1 trials in both solid and hematological cancers in 2008."

James S. Burns, EntreMed President & CEO commented, "The IND for ENMD-2076 represents an important milestone for EntreMed. This compound has shown significant single-agent activity, including tumor regression in multiple animal models. Moving ENMD-2076 forward into clinical development is consistent with our strategy of investing preferentially behind small molecule, orally-administered, multi-mechanism product candidates with potent single-agent antitumor activity and strong intellectual product coverage. Our goal is to commence clinical trials for ENMD-2076 and, in parallel, seek a development partner to help us accelerate the development of what I believe is an exciting oncology opportunity for EntreMed."

About EntreMed

EntreMed, Inc. is a clinical-stage pharmaceutical company developing therapeutic candidates primarily for the treatment of cancer and inflammation. MKC-1 is currently in multiple Phase 2 clinical trials for cancer. MKC-1 is an oral cell-cycle regulator with activity against the mTOR pathway. PanzemŽ NCD is currently in multiple Phase 2 trials for cancer. Additionally, ENMD- 1198, a novel tubulin-binding agent, is in Phase 1 studies in advanced cancers. PanzemŽ (2-methoxyestradiol) is also in multiple Phase 2 studies in oncology patients. The Company has approved IND applications for PanzemŽ in rheumatoid arthritis, and ENMD-2076, a dual-acting Aurora-angiogenesis inhibitor, for cancer. EntreMed's goal is to develop and commercialize new compounds based on the Company's expertise in angiogenesis, cell-cycle regulation and inflammation - processes vital to the treatment of cancer and other diseases, such as rheumatoid arthritis. Additional information about EntreMed is available on the Company's web site at www.entremed.com and in various filings with the Securities and Exchange Commission.

Forward Looking Statements

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act with respect to the outlook for expectations for future financial or business performance (including the timing of royalty revenues and future R&D expenditures), strategies, expectations and goals. Forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Forward-looking statements speak only as of the date they are made, and no duty to update forward-looking statements is assumed. Actual results could differ materially from those currently anticipated due to a number of factors, including those set forth in Securities and Exchange Commission filings under "Risk Factors," including risks relating to the need for additional capital and the uncertainty of additional funding; variations in actual sales of ThalomidŽ, risks associated with the Company's product candidates; the early-stage products under development; results in preclinical models are not necessarily indicative of clinical results, uncertainties relating to preclinical and clinical trials; success in the clinical development of any products; dependence on third parties; future capital needs; and risks relating to the commercialization, if any, of the Company's proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks).


Source: EntreMed

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