Healthcare Industry News: taxane
News Release - September 12, 2006
EntreMed Commences Panzem(R) NCD Phase 2 Study in Prostate CancerROCKVILLE, Md., Sept. 12 (HSMN NewsFeed) -- EntreMed, Inc. (Nasdaq: ENMD ), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, today announced commencement of a multi-center Phase 2 study with its lead clinical- stage drug candidate, PanzemŽ NCD (2ME2 or 2-methoxyestradiol), in patients with hormone-refractory prostate cancer (HRPC). Initially, the study will be conducted by the University of Wisconsin Comprehensive Cancer Center, as a member of the Prostate Cancer Clinical Trial Consortium, with additional sites joining during the third quarter. Dr. Glenn Liu, Assistant Professor of Medicine, University of Wisconsin, will serve as the principal investigator.
Patients with evidence of progressive metastatic disease or known metastatic disease and rising PSA, during or after treatment with a taxane- based regimen, are expected to be enrolled in the study. The purpose of the study will be to assess the antitumor activity, safety, and pharmacokinetics of PanzemŽ NCD in patients with HRPC. This study will expand the results obtained to date on the use of PanzemŽ in men with HRPC.
Dr. Liu commented on commencement of the study, "A major problem with assessing treatment benefit in prostate cancer is the difficulty of evaluating responses in patients with bony metastasis. In these patients, the utility of measuring a PSA response may or may not be clinically meaningful using a novel agent like PanzemŽ NCD. For this study, we chose to assess a valuable clinical endpoint (progression-free survival), as well as a pharmacodynamic endpoint using current imaging technology. This will also allow us to fully evaluate the benefits of potential new anticancer agents like PanzemŽ NCD."
Carolyn F. Sidor, M.D., M.B.A., EntreMed Vice President and Chief Medical Officer, commented, "HRPC has been a focus of our development plan for PanzemŽ and working with the Prostate Cancer Clinical Trial Consortium allows us to continue this effort at multiple sites well-known for their expertise in prostate cancer trials. Very few options exist for patients with taxane-refractory HRPC and most chemotherapeutics are associated with considerable toxicity. Our goal is to provide patients with an option that may stabilize their disease without significant side effects."
About Prostate Cancer
Prostate cancer is one of the most common cancers in men and accounts for about 10% of cancer-related deaths in men. The American Cancer Society estimates that approximately 230,000 new cases will be diagnosed in the United States in 2006, resulting in approximately 27,000 deaths. Chances of developing prostate cancer increase in men over 50 years of age. Prostate cancer occurs when cells within the prostate gland grow uncontrollably, creating small tumors.
EntreMed, Inc. (Nasdaq: ENMD ) is a clinical-stage pharmaceutical company developing therapeutic candidates primarily for the treatment of cancer and inflammation. PanzemŽ (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 ThalomidŽ, 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).
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