Healthcare Industry News:  MKC-1 

Biopharmaceuticals Oncology

 News Release - April 25, 2006

EntreMed's Panzem(R) NCD Enters Clinical Trial in Metastatic Breast Cancer

Duke University to Combine Panzem(R) NCD with Taxol(R)

ROCKVILLE, Md., April 25 (HSMN NewsFeed) -- EntreMed, Inc. (Nasdaq: ENMD ), a clinical-stage pharmaceutical company developing therapeutics primarily for the treatment of cancer and inflammatory diseases, today announced the commencement of a Phase 1b study to test its lead clinical-stage drug candidate, Panzem® NCD (2ME2), in combination with paclitaxel (Taxol®) in patients with metastatic breast cancer. The single- center study will be conducted at the Duke University Medical Center under a grant from the Susan G. Komen Breast Cancer Foundation. Kimberly L. Blackwell, M.D., Director, Clinical Trials in Breast Cancer at the Duke University Medical Center, will serve as principal investigator for the study.

Patients with clinical stage IV or inoperable stage III breast cancer are expected to be enrolled in the study. The purpose of the study will be to evaluate the biologic effects on tissue and plasma in patients treated with paclitaxel alone and in combination with Panzem® NCD (2-methoxyestradiol or 2ME2). The safety and tolerability of Panzem® NCD in combination with weekly paclitaxel will also be evaluated.

Kimberly L. Blackwell, M.D., commented on the study, "By adding a novel drug candidate, such as Panzem® NCD, to traditional chemotherapy, we believe that there is the potential to improve the anticancer effects observed when compared to chemotherapy alone. The concept of targeting the angiogenic pathways has already proven successful with commercialized agents in breast cancer. Through this study, we will combine an approved standard-of-care agent, paclitaxel, with an experimental drug candidate, Panzem® NCD, with the hope to further support that success."

Breast cancer remains a significant health problem, killing over 40,000 American women annually, despite the recent introduction of new therapies. A primary resistance mechanism is thought to be the upregulation of HIF-1alpha. Prior studies conducted by the Duke team demonstrated that the inhibition of HIF-1alpha causes near-complete destruction of tumor vessels and significantly improved radio-sensitivity in radiation resistant breast tumors. The inhibition of HIF-1alpha may have the same or similar impact on chemotherapy- resistant tumors. Panzem® is a potent inhibitor of HIF-1alpha, and its down-regulation is closely associated with 2ME2's tubulin inhibitor properties. HIF-1alpha is over-expressed in more than 70% of human tumors and HIF-1alpha over-expression correlates with tumor aggressiveness, metastases and poor prognosis.

Carolyn F. Sidor, M.D., M.B.A, EntreMed Vice President and Chief Medical Officer, commented on the study, "Based on data from clinical and preclinical studies, we believe that 2ME2 may be particularly well-suited to attack tumors that are dependent on the pro-angiogenic activity of HIF-1alpha. Panzem® NCD's safety profile and lack of MDR chemoresistance offer opportunities for combining it with conventional chemotherapies to increase their effectiveness without increasing toxicity. This study is designed to determine if blocking HIF-1alpha will overcome cancer cell resistance to standard chemotherapeutic agents, and we expect to obtain valuable information regarding Panzem® NCD's potential to complement chemotherapy."

Panzem® NCD is a novel anticancer agent, which is part of a next generation of antimitotic cancer drugs that bind to tubulin and work through multiple cellular pathways. 2ME2 can attack tumors on multiple fronts -- directly by disrupting microtubules, an intracellular matrix necessary for the rapid division of cancer cells (mitosis), by inducing programmed cell death (apoptosis), and by blocking blood vessels that feed tumors (angiogenesis inhibition). EntreMed is currently evaluating Panzem® NCD in Phase 2 clinical oncology studies.

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 Phase 2 clinical trials for cancer, as well as in preclinical development for rheumatoid arthritis. MKC-1, an oral cell cycle regulator, is also in Phase 2 studies 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 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, 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; the integration of Miikana and its product candidates; the early stage of our products under development; that 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; our dependence on third parties; and regulatory risks.


Source: EntreMed

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