PanzemÂ® Demonstrates Safety and Clinical Benefit in Hormone Refractory Prostate Cancer
Phase II PanzemÂ® Capsule Results Published in Clinical Cancer Research
September 27, 2005
ROCKVILLE, MD, September 27, 2005—EntreMed, Inc. (Nasdaq: ENMD), a clinical-stage pharmaceutical company developing therapeutics primarily for the treatment of cancer and inflammatory diseases, today announced the publication of results of the multi-center Phase II study for PanzemÂ® capsules (2ME2, 2-methoxyestradiol) in hormone refractory prostate cancer. The results were published in the September 15, 2005 issue of Clinical Cancer Research (Vol. 11, Issue 18, pp. 6625-6633). Christopher J. Sweeney, M.D., Co-Director, Experimental and Developmental Therapeutics Program, Indiana University Cancer Center and George Wilding, M.D., Director, University of Wisconsin Comprehensive Cancer Center were Principal Investigators for the Phase II study.
In this double-blind, randomized Phase II study, 33 patients received either 400 mg or 1200 mg of 2-methoxyestradiol per day. Patients were treated until disease progression. Seven patients treated at the higher dose level, and one patient in the lower dose level, experienced a 21 to 40 percent decrease in PSA (prostate specific antigen) levels. Both doses of PanzemÂ® capsules were well tolerated in this population. Dr. Sweeney commented on the results of the study, â€œA dose-dependent increase in time on study and decrease in average PSA velocity were identified through a post-hoc analysis of data. This analysis was made possible by the randomized, double-blind design of the study. PanzemÂ® capsules were well tolerated and, at the higher dose level, demonstrated possible evidence of clinical benefit in patients with hormone refractory prostate cancer. Although this information does not provide definitive evidence of activity, it does support the development and evaluation of the new formulation in hormone refractory prostate cancer.â€
Carolyn F. Sidor, M.D., M.B.A, EntreMed Vice President and Chief Medical Officer, commented on the results of the study, â€œThis study has provided valuable pharmacokinetic, safety and clinical information about 2ME2 in patients with hormone refractory prostate cancer. Two Phase 1b studies with PanzemÂ® NCD, a liquid suspension of 2ME2 designed to enhance bioavailability, are currently underway in patients with advanced cancers under the direction of these same investigators. As we make plans for Phase II studies, hormone refractory prostate cancer remains high on our list of priority indications for PanzemÂ® NCD.â€
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 2005, resulting in approximately 30,000 deaths. Chances of developing prostate cancer increase in men over 50 years of age. Prostate cancer occurs when the 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. PanzemÂ® (2-methoxyestradiol or 2ME2), the Company’s lead drug candidate, is currently in clinical trials for cancer, as well as in preclinical development for non-oncology indications. 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 Companyâ€™s website at www.entremed.com and in various filings with the Securities and Exchange Commission.
Forward Looking Statements
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