ROCKVILLE, MD – October 24, 2007 – EntreMed, Inc. (Nasdaq: ENMD), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, today announced the presentation of results for its Phase 2, open-label study for Panzem® NCD (2ME2 or 2-methoxyestradiol) in patients with ovarian cancer. The results were presented by Dr. Daniela Matei, principal investigator for the study representing the Hoosier Oncology Group, at the AACR-NCIEORTC International Conference on Molecular Targets and Cancer Therapeutics being held this week in San Francisco, California.
Data from the Phase 2 study demonstrate that Panzem® NCD, administered as a single agent in patients with platinum refractory epithelial ovarian cancer, resulted in one patient with a confirmed partial response of their CA-125. Five patients, out of the 18 patients enrolled, achieved stable disease lasting greater than three months. Panzem® NCD was well tolerated and no significant neuropathy, myelosuppression or thromboembolic side effects were reported. Three patients remained on study for more than 6 months and two of these patients are still on study.
Data from in vitro studies demonstrated that 2ME2 has activity against a variety of ovarian carcinoma cell lines including those resistant to other chemotherapeutic agents. In preclinical models of ovarian cancer, 2ME2 has shown a significant survival advantage compared to animals that did not receive treatment. Furthermore, in a Phase 1 clinical study conducted by the National Cancer Institute with Panzem® Capsules, an ovarian cancer patient with the clear cell subtype experienced a durable partial response to 2ME2 lasting over three years after failing three prior chemotherapy regimens.
Carolyn F. Sidor, M.D., EntreMed Vice President and Chief Medical Officer commented on the study, “Results from this study continue to demonstrate that Panzem® NCD has modest activity and an excellent safety profile as a single agent in heavily pretreated and refractory ovarian cancer patients. The stage is now set for us to consider additional trials where Panzem® NCD can be combined with approved agents in an attempt to provide clinical benefit to patients with advanced cancers.”
To view the poster presentation, visit the Company’s web site at www.entremed.com.
About Ovarian Cancer
Ovarian cancer accounts for 4% of all cancers among women in the United States, and ranks fifth as the cause of cancer deaths. The American Cancer Society estimates that there will be approximately 22,000 newly diagnosed cases of ovarian cancer in the U.S. in 2007 resulting in approximately 15,000 deaths. About half of all ovarian cancers occur in post-menopausal women. Ovarian cancer is frequently asymptomatic in the early stages. As a result, ovarian cancer is often not diagnosed until stage III or IV, where 5-year survival rates decline to 10-20%. Current drug therapy involves paclitaxel and carboplatin/cisplatin regimens. Many patients develop resistance to these drugs, so there is substantial need for innovative therapies that can overcome resistance, either as a single agent or in combination with cytotoxic agents.
EntreMed, Inc. is a clinical-stage pharmaceutical company developing therapeutic candidates primarily for the treatment of cancer and inflammation. Panzem® NCD (2-methoxyestradiol or 2ME2) is currently in multiple Phase 2 clinical trials for cancer. MKC-1, an oral cell-cycle regulator, is in multiple Phase 1 and 2 studies for cancer. ENMD-1198, a novel tubulin-binding agent, is in Phase 1 studies in advanced cancers. Panzem® is also in preclinical development for rheumatoid arthritis, and ENMD-2076, a dual-acting Aurora-angiogenesis inhibitor, is in preclinical development 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 web site 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®, 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 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).