EntreMed, Inc. Presents Data For MKC-1 In Preclinical Cancer Models

ROCKVILLE, Md., Nov. 9 /PRNewswire-FirstCall/ -- EntreMed, Inc. , a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, today announced the presentation of preclinical results for MKC-1, its novel cell cycle inhibitor. The data were presented by EntreMed scientists at the 18th European Organization for Research and Treatment of Cancer, National Cancer Institute, American Association for Cancer Research (EORTC-NCI-AACR) Symposium on “Molecular Targets and Cancer Therapeutics” being held this week at the Prague Congress Centre in Prague, Czech Republic.

(Logo: http://www.newscom.com/cgi-bin/prnh/20010620/ENMDLOGO )

MKC-1 is a novel, orally-active cell cycle inhibitor with in vitro and in vivo efficacy against a broad range of human solid tumor cell lines, including multi-drug resistant cell lines. In previous studies, MKC-1 demonstrated broad-acting antitumor effects, showing tumor growth inhibition or regression in multiple preclinical models, including paclitaxel-resistant models. 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. These effects are consistent with mechanisms resulting from MKC-1 binding to multiple intracellular targets, including tubulin and the importin-beta proteins. The importin-beta family of proteins plays a critical role in nuclear transport and cell division.

Results from preclinical studies presented at the Prague meeting demonstrated that MKC-1 showed significant antitumor activity as both a single agent and in combination with Tarceva(R) (erlotinib) in non-small cell lung cancer (NSCLC) and pancreatic cancer models. Tarceva(R) is a small molecule human epidermal growth factor/epidermal growth factor receptor (EGF/EGFR) inhibitor that is approved for the treatment of NSCLC. MKC-1 in combination with Tarceva(R) was well tolerated and resulted in an additive antitumor response in preclinical models.

Data presented today from in vitro studies showed that MKC-1 binds to tubulin at the colchicine binding site and destabilizes microtubules in cells. Results from in vitro studies also demonstrate that MKC-1 binds to GSK-3beta and inhibits enzymatic activity in some cell lines, which may result in inhibition of NFkappaB activation. MKC-1 decreased the activity of several proteins that play a role in promoting tumor growth (GSK-3beta, pNFkappaB, pJAK2, pSTAT3, HIF-1alpha and pAkt). MKC-1 also showed enhanced activity in combination with antifolates in vitro.

Carolyn F. Sidor, M.D., M.B.A., EntreMed Vice President and Chief Medical Officer, commented on the results, “These data represent continued progress with our MKC-1 program and provide further support for a Phase 2 clinical trial with MKC-1 in pancreatic cancer. MKC-1 has shown tumor responses in previous clinical trials for breast cancer and NSCLC. MKC-1 is currently in Phase 2 trials for metastatic breast cancer and non-small cell lung cancer, as well as a Phase 1 clinical trial for leukemia.”

To view the poster presentation, visit Scientific Presentations under the Therapeutic Pathways section of the Company’s web site at http://www.entremed.com.

Tarceva(R) is a registered trademark of its owners and is not a registered trademark of EntreMed, Inc.

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 1 and 2 clinical trials for cancer, as well as in preclinical development for rheumatoid arthritis. MKC-1, an oral cell cycle regulator, is in Phase 1 and 2 clinical trials for 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 development of 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 EntreMed, Inc. Associate Director Corporate Communications & Investor Relations (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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