ROCKVILLE, Md., June 06, 2007 /PRNewswire-FirstCall/ -- EntreMed, Inc. , a clinical-stage pharmaceutical company developing therapeutics primarily for the treatment of cancer and inflammatory diseases, announced the presentation of interim data from the Phase 1b study with Panzem(R) NCD (2ME2 or 2-methoxyestradiol) in combination with Taxol(R) (paclitaxel) in patients with metastatic breast cancer. The study is being 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, and principal investigator presented the data during a podium presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting this week in Chicago, Illinois.
The primary objective of the study was to evaluate the effects of standard chemotherapy (paclitaxel) alone and in combination with the antiangiogenic drug, 2-methoxyestradiol, on biomarkers of hypoxia and angiogenesis in metastatic breast cancer. Prior preclinical studies conducted by the Duke team demonstrated that inhibition of HIF-1alpha (hypoxia-inducible factor-1 alpha) caused near-complete destruction of tumor vessels and significantly improved radio-sensitivity in radiation resistant breast tumors. The inhibition of HIF-1alpha was thought to have the same or similar impact on chemotherapy-resistant tumors. 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.
Results were presented for ten patients with clinical stage IV or inoperable stage III breast cancer who received orally-administered Panzem(R) NCD in combination with Taxol(R). All ten patients received prior anthracycline therapy and nine received taxane therapy. Of the ten patients evaluated, all ten patients completed four weeks, while seven of the ten patients completed eight weeks of therapy. Among the ten evaluable patients, there was one complete response (CR), one partial response (PR), and one patient with a 30% reduction in tumor volume.
Patients also underwent sequential biopsies of their tumors to evaluate biomarkers of hypoxia and angiogenesis. Paclitaxel causes an increase in tumor HIF-1alpha expression, which is downregulated by 2ME2. Changes were observed in HIF-1 regulated proteins, including tissue VEGF, VEGFR-2, plasma PAI-1, and osteopontin. Based on these findings, enrollment is continuing to further define the relationship between 2ME2 therapy and the effects on these biomarkers with the goal of identifying patients who would most benefit from 2ME2's unique mechanisms of action.
Carolyn F. Sidor, M.D., M.B.A, EntreMed Vice President and Chief Medical Officer, commented on the study, "Results to date are encouraging and further support EntreMed's rationale for using Panzem(R) NCD in combination with approved chemotherapeutics. Panzem(R) NCD's safety profile and lack of MDR chemoresistance offer opportunities for combining it with conventional chemotherapies to increase their effectiveness without increasing toxicity."
Dr. Sidor further commented, "Breast cancer remains a significant health problem, killing over 40,000 American women annually, despite the introduction of new therapies. A primary resistance mechanism to chemotherapeutic agents is thought to be the upregulation of HIF-1alpha and Panzem(R) is a potent inhibitor of HIF-1alpha. We hope that this study will also begin to identify biomarkers that we can use to further identify patients who would most benefit from treatment with Panzem(R) NCD."
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 multiple Phase 2 clinical trials for cancer, as well as in preclinical development for rheumatoid arthritis. MKC-1, an oral cell-cycle regulator, is in various Phase 2 studies for cancer. ENMD-1198, a novel tubulin-binding agent, is 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 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 Company's 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 tria ls; 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 EntreMed, Inc. 240.864.2643
CONTACT: Ginny Dunn, Associate Director, Corporate Communications &Investor Relations, EntreMed, Inc., +1-240-864-2643
Web site: http://www.entremed.com//
Ticker Symbol: (NASDAQ-NMS:ENMD)
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