Home Press Releases Report Demonstrates Activity of 2ME2 With Paclitaxel in Head and Neck Carcinoma Preclinical Results Support Potential Clinical Study
Report Demonstrates Activity of 2ME2 With Paclitaxel in Head and Neck Carcinoma Preclinical Results Support Potential Clinical Study
Jan 19,2005

ROCKVILLE, MD, Jan. 19—EntreMed, Inc. (Nasdaq: ENMD), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammation, today announced a published preclinical report supporting the use of 2-methoxyestradiol (2ME2) in combination with paclitaxel in the treatment of recurrent or advanced head and neck squamous cell carcinoma (HNSCC). Paclitaxel is a first-line treatment for recurrent head and neck squamous cell carcinoma. These findings, published in the December issue of Clinical Cancer Research (Vol. 10, No. 24: 8665- 8673), demonstrated that 2ME2 exhibited both antitumor and antiangiogenic activity in an animal model of head and neck squamous cell carcinoma. EntreMed is currently conducting clinical studies with 2ME2 (Panzem®) in patients with advanced cancer.

Specifically, the study demonstrated that 2ME2, alone or in combination with paclitaxel, significantly inhibited tumor growth in a preclinical xenograft model. The study also showed that 2ME2 inhibits tumor cell proliferation and promotes apoptosis (cell death) in vitro, as well as providing an additive or synergistic effect with paclitaxel.

The study further demonstrated that 2ME2 inhibits HIF-1αlpha (hypoxia- inducible factor) nuclear activity in a dose-dependent manner and that 2ME2 affects the expression of HIF-1αlpha regulated genes, specifically up- regulating bid, a pro-apoptotic bcl-2 family member, and inhibits the expression of VEGF (vascular endothelial growth factor), an angiogenic growth factor.

EntreMed Vice President and Chief Medical Officer, Carolyn F. Sidor, M.D., commented on the publication, “The findings from this study further support the antitumor and antiangiogenic activities of 2ME2. Inhibiting HIF-1αlpha is important, since its overexpression correlates with metastasis, decreased responses to chemotherapy and radiation and mortality in HNSCC. This study suggests a new possible therapeutic indication where anti-HIF-1αlpha agents like 2ME2 could be useful in treating advanced cancers. The use of 2ME2 in combination with paclitaxel, which also induces apoptosis, provides important input for further development of Panzem® NCD alone and in combination with chemotherapy.”

Head and neck squamous cell carcinoma affects over 300,000 Americans, with nearly 30,000 new cases annually. These tumors are generally already advanced when diagnosed, the five-year mortality rate is about 50%, and tumor recurrence is common. The complete article, “2-Methoxyestradiol Inhibits Hypoxia-Inducible Factor 1αlpha, Tumor Growth, and Angiogenesis and Augments Paclitaxel Efficacy in Head and Neck Squamous Cell Carcinoma,” co-authored by scientists at the National Institutes of Health and EntreMed, Inc., is available in Clinical Cancer Research (Vol. 10, No. 24, pg. 8665).

About EntreMed

EntreMed, Inc. (Nasdaq: ENMD) is a clinical-stage pharmaceutical company developing therapeutic candidates primarily for the treatment of cancer and inflammation. Panzem® (2-Methoxyestradiol or 2ME2), the Company’s lead drug candidate, is currently in clinical trials for advanced cancer, as well as in preclinical development for indications outside of oncology. 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. The Company’s expertise has also led to the discovery of new molecules, including analogs of 2ME2, peptides of tissue factor pathway inhibitor (TFPI), and inhibitors of fibroblast growth factor-2 (FGF-2) and proteinase activated receptor-2 (PAR-2). EntreMed is developing these potential drug candidates for either in-house advancement or external partnering. 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. Panzem® NCD is in clinical trials and has not been approved by the Food and Drug Administration.

Forward Looking Statements

This release contains, and other statements that EntreMed may make may contain, 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, strategies, expectations and goals. Forward-looking statements are typically identified by words or phrases such as “believe,” “feel,” “expect,” “anticipate,” “intend,” “outlook,” “estimate,” “target,” “assume,” “goal,” “objective,” “plan,” “remain,” “seek,” “trend,” and variations of such words and similar expressions, or future or conditional verbs such as “will,” “would,” “should,” “could,” “might,” “can,” “may,” or similar expressions. 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 EntreMed assumes no duty to update forward-looking statements. Actual results could differ materially from those currently anticipated due to a number of factors, including those set forth in EntreMed’s Securities and Exchange Commission filings under “Risk Factors,” including risks relating to EntreMed’s need for additional capital and the uncertainty of additional funding; the early-stage products under development; uncertainties relating to clinical trials; our success in the further clinical development of Panzem® NCD, 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).