ROCKVILLE, MD, June 4, 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 Phase 2 results for the capsule formulation of one of its lead oncology drug candidates, Panzem® (2-methoxyestradiol or 2ME2), in patients with relapsed and plateau phase multiple myeloma. The data were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting being held this week in Chicago, Illinois. The study was conducted at the Mayo Clinic and the Dana-Farber Cancer Institute with Dr. Vincent Rajkumar and Dr. Paul Richardson as principal investigators, respectively.
Results of the Phase 2 study demonstrated prolonged stable disease and minor responses in patients receiving the original formulation of Panzem® Capsules. Sixty patients with relapsed or plateau phase multiple myeloma were enrolled in the study. Panzem® Capsules were well tolerated and did not cause significant neuropathy (peripheral nerve damage), myelosuppression (decreased bone marrow activity) or thromboembolic disease. Progression free survival (PFS) rates were 24%, 17% and 11% for all patients at 1, 2, and 3 years. Five patients continue to receive Panzem® Capsules, including three patients with plateau phase disease who have been on study for over four years without disease progression. EntreMed has also received orphan drug designation for 2ME2 in multiple myeloma from the FDA.
Panzem® is an orally-active small molecule that attacks tumor cells through multiple mechanisms of action and blocks the development of new blood vessels that feed tumor cells. One such mechanism is the upregulation of death receptor 5 (DR5) leading to apoptosis. Panzem® also reduces levels of IL-6, a known growth factor for myeloma cells. Panzem® Capsules continue to be used by the five patients remaining on the study. An improved oral liquid formulation, Panzem® NCD, is now being used in multiple Phase 1 and 2 clinical studies. Panzem® NCD has been shown to increase the exposure of 2ME2 in patients by 5 to 10 fold. Interim results from two additional clinical studies using Panzem® NCD are also being presented during the conference.
Carolyn F. Sidor, M.D., M.B.A, EntreMed Vice President and Chief Medical Officer, commented, “We are encouraged by these results as they demonstrate antitumor activity and represent a rationale for future studies with Panzem® NCD in multiple myeloma patients. This is especially true considering the higher drug levels possible with the NCD formulation. In addition, since several patients have received Panzem® for years, the data will help us build our safety profile to support additional oncology uses and for our planned program in rheumatoid arthritis.”
To view the poster presentation, visit the Recent Presentations section of the Company’s web site at www.entremed.com.
About Multiple Myeloma
Multiple myeloma is a type of cancer formed by cancerous plasma cells in the blood. When plasma cells grow uncontrollably, they can form a tumor, usually in the bone marrow. This tumor type is called myeloma, and if there are many tumors, it is called multiple myeloma. The exact cause of multiple myeloma is still unclear. Several risk factors associated with multiple myeloma include age and gender, race, radiation exposure, family history, and weight. The American Cancer Society estimates that approximately 19,000 new cases of multiple myeloma will be diagnosed in the United States in 2007, and approximately 11,000 deaths.
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 in Phase 2 studies for 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 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 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).