ROCKVILLE, MD, May 29, 2007 – EntreMed, Inc. (NASDAQ:ENMD), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, today announced the commencement of a Phase 2 combination study with Panzem® NCD (2-methoxyestradiol or 2ME2) and Temodar® (temozolomide) in patients with recurrent glioblastoma multiforme (GBM). Annick Desjardins, M.D., FRCPC, Associate in Medicine at the Preston Robert Tisch Brain Tumor Center at Duke University Medical Center will serve as principal investigator. The purpose of the single center, open-label study will be to determine progression free survival (PFS), pharmacokinetics and safety in GBM patients receiving orally-administered Panzem® NCD in combination with Temodar®.
Panzem® NCD is an orally-administered anticancer agent that attacks tumor cells through multiple mechanisms of action (MOA) and blocks the development of new blood vessels that feed tumor cells. Panzem’s MOAs include apoptosis (programmed cell death), tumor cell cycle inhibition at the G2/M phase of mitosis, and disruption of angiogenesis through the inhibition of hypoxia inducible factor-1 alpha (HIF-1α), a protein required for angiogenesis and cell survival under stress. By these mechanisms, Panzem® has the potential to attack cancer cells through multiple pathways that affect the formation and replication of tumor cells, and can interrupt the formation of blood vessels that nourish tumor cells and sustain tumor growth.
Panzem® NCD is currently being evaluated in multiple Phase 2 studies in patients with a variety of cancers including GBM, prostate cancer, ovarian cancer, carcinoid tumors, and renal cell carcinoma. Panzem® NCD has been well-tolerated with an acceptable safety profile, allowing it to be combined with other anticancer therapies such as Temodar®.
Glioblastoma is an aggressive and highly vascularized disease. EntreMed has previously presented preclinical data demonstrating that combination treatment with Panzem® and Temodar® resulted in tumor regression compared to either agent alone in a glioblastoma model.
Carolyn F. Sidor, M.D., M.B.A, EntreMed Vice President and Chief Medical Officer, commented, “Commencement of this Phase 2 study represents a significant milestone in the clinical development plan for Panzem® NCD. The rationale for this combination study is based on preclinical results demonstrating substantial tumor regression with Panzem® both alone and in combination with Temodar® in GBM models. We are currently conducting a single-agent Phase 2 clinical study with Panzem® NCD in GBM patients at the Duke Medical Center. The goal of the new trial is to determine the potential therapeutic benefit of combining Panzem® NCD with the current standard of care, Temodar®. We anticipate presenting interim clinical data from the single-agent study of Panzem® NCD in GBM patients at the ASCO annual meeting to be held June 1-5, 2007.”
For more information on this study, visit the Clinical Trials section of the Company’s web site at www.entremed.com.
Temodar® is a registered trademark of its owner and not of EntreMed, Inc. Panzem® is a registered trademark of EntreMed, Inc.
Approximately 40,000 cases of primary central nervous system (CNS) cancers are diagnosed each year in the United States, of which 17,000 are malignant tumors. Malignant CNS tumors cause approximately 13,000 deaths per year, or about three-fourths of the new annual malignant cases. Glioblastoma multiforme (GBM), also known as grade IV astrocytoma, is the most common and aggressive type of primary brain tumor. GBMs account for approximately 52% of all primary brain tumors. The tumor forms in the glial (supportive) tissue of the brain and invades adjacent tissue. The tumor cells do not spread throughout the body and symptoms are caused by the tumor invading the brain. These tumors have significant regions of hypoxia and are highly dependent on angiogenesis for growth.
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).