EntreMed, Inc. Commences MKC-1 Clinical Trial In Leukemia Patients

ROCKVILLE, Md., Sept. 26 /PRNewswire-FirstCall/ -- EntreMed, Inc. , a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, today announced commencement of a Phase 1 study with its clinical-stage drug candidate, MKC-1, in patients with hematological (blood) malignancies. The study will be conducted at the University of Texas MD Anderson Cancer Center in Houston, Texas. Francis J. Giles, M.D., Professor, Department of Leukemia at the MD Anderson Cancer Center, will serve as Principal Investigator. MKC-1 is also being evaluated currently in a Phase 2 clinical study in patients with metastatic breast cancer.

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Patients with relapsed or refractory leukemias will be enrolled. At the present time, there is a need for more effective therapies for patients with relapsed or refractory leukemias. MKC-1 has shown good activity against a variety of hematological cell lines leading to interest in a clinical trial in patients with leukemias.

MKC-1 is a novel, orally active cell cycle inhibitor with in vitro and in vivo efficacy against a wide range of human solid tumor cell lines, including multi-drug resistant cell lines. MKC-1 has demonstrated broad-acting antitumor effects, showing tumor growth inhibition or regression in multiple animal models, including paclitaxel-resistant models. In addition to the strong preclinical activity of MKC-1 towards solid tumor lines, the lack of neuropathy and cardiotoxicity seen in clinical trials suggests that MKC-1 may also be valuable in the treatment of hematological cancers.

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 in multiple cell lines. These effects are consistent with a mechanism resulting from MKC-1 binding to its intracellular targets, tubulin and the importin beta proteins. The importin beta family of proteins plays a critical role in nuclear transport and cell division.

Carolyn F. Sidor, M.D., M.B.A., EntreMed's Vice President and Chief Medical Officer, commented, "Initiation of this clinical trial represents continued progress on our clinical development plan for MKC-1. This is the first clinical study where MKC-1 will be given to patients with hematological cancers. These patients may be particularly suited for MKC-1 treatment based on MKC-1's mechanisms of action. MD Anderson is well-known for its expertise in hematological cancers and Dr. Giles has substantial experience in evaluating new therapies in this patient population."

For information on this study, visit the Clinical Trials section of the Company's web site at http://www.entremed.com.

About Hematological Malignancies

Hematological malignancies are cancers that affect blood, bone marrow and lymph nodes. As the blood, bone marrow and lymph nodes are intimately connected through the immune system, a disease affecting one of the three will often affect the other. Chromosomal translocations are a common cause of these diseases, which leads to a different approach in diagnosis and treatment. Diseases characterized as hematological malignancies include leukemia, lymphoma and multiple myeloma.

About EntreMed

EntreMed, Inc. is a clinical-stage pharmaceutical company developing therapeutic candidates primarily for the treatment of cancer and inflammation. Panzem(R) (2-methoxyestradiol or 2ME2), the Company's lead drug candidate, is currently in Phase 2 clinical trials for cancer, as well as in preclinical development for rheumatoid arthritis. MKC-1, an oral cell cycle regulator, is in Phase 2 studies for metastatic breast cancer. ENMD-1198, a novel tubulin binding agent, is also in Phase 1 studies in advanced cancers. 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 website at http://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 Thalomid(R), risks associated with the integration of Miikana and its 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).

CONTACT: Ginny Dunn, Associate Director, Corporate Communications & Investor Relations of EntreMed, Inc., +1-240-864-2643.

Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20010620/ENMDLOGOAP Archive: http://photoarchive.ap.orgPRN Photo Desk, photodesk@prnewswire.comEntreMed, Inc.

CONTACT: Ginny Dunn, Associate Director, Corporate Communications &Investor Relations of EntreMed, Inc., +1-240-864-2643

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