ROCKVILLE, Md., March 6 /PRNewswire-FirstCall/ -- EntreMed, Inc. , a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, today announced that it has commenced a Phase 2 clinical trial to evaluate the safety and efficacy of its lead clinical-stage drug candidate, Panzem(R) (2- methoxyestradiol or 2ME2), alone and in combination with Sutent(R) (sunitinib) in patients with metastatic renal cell carcinoma. The study will be conducted at the University of Wisconsin, Paul P. Carbone Comprehensive Cancer Center, followed by additional centers. Dr. Glenn Liu, Assistant Professor of Medicine, University of Wisconsin, will serve as the principal investigator.
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The study will evaluate the potential of Panzem(R) NCD in patients who have failed treatment with sunitinib, as well as patients who are currently being treated with sunitinib, but are showing signs of disease progression. The combination portion will determine if the addition of Panzem(R) NCD will restore tumor response by blocking tumor growth at both the level of the VEGF receptor and by inhibiting HIF-1alpha.
Renal cell cancers are frequently associated with a mutant or inactive gene (a VHL mutation) that results in an overexpression of VEGF and PDGF through a mechanism involving HIF-1alpha. HIF-1alpha is responsible for the expression of a number of growth factors including VEGF, PDGF, TGF, erythropoietin, Glut-1, PAI-1 and CAIX, which can promote angiogenesis. Panzem(R) NCD inhibits HIF-1alpha and has been shown in preclinical experiments to be both an antiproliferative agent and an antiangiogeneic agent.
Dr. Liu commented on the study, “It has been hypothesized that a mechanism for tyrosine kinase inhibitor failure is a compensatory increase in HIF- 1alpha, a key regulatory protein responsible for the expression of several growth factors and survival proteins. This study will test the hypothesis that the addition of Panzem(R) NCD will restore tumor response by blocking HIF- 1alpha as well as inhibit tumor progression in sunitinib refractory patients.”
Carolyn F. Sidor, M.D., M.B.A., EntreMed Vice President and Chief Medical Officer, commented, “This study is an important addition to our clinical development program. Although great strides have been made in the treatment of renal cell cancer with the approval of tyrosine kinase inhibitors such as sunitinib, patients tolerize to these drugs and eventually progress with their disease. Through this study, we will be able to determine the potential benefit of Panzem(R) NCD as both a single agent and in combination with an approved therapeutic in this patient population.”
Panzem(R) NCD is currently in Phase 2 clinical trials for brain, ovarian, carcinoid, and prostate cancers and a Phase 1 study in metastatic breast cancer.
Sutent(R) is a registered trademark of its owner and is not a registered trademark of EntreMed, Inc.
About Renal Cell Cancer
Renal cell carcinoma, also called renal adenocarcinoma or hypernephroma, is the development of cancerous changes in the cells of the kidney tubules. Renal cell carcinoma is considered the most common type of kidney cancer and represents more than 90% of malignant kidney tumors. As renal cell cancer progresses, it can invade organs near the kidney such as the liver, colon or pancreas. Cancer cells may also metastasize (spread) to the brain, lungs, bone or lymph nodes. The American Cancer Society estimates that approximately 51,000 new kidney cancer cases will be diagnosed in the United States in 2007, resulting in approximately 13,000 deaths.
About EntreMed
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 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 http://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 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).
CONTACT: Ginny Dunn Associate Director, Corporate Communications & Investor Relations EntreMed, Inc. 240.864.2643
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CONTACT: Ginny Dunn, Associate Director, Corporate Communications &Investor Relations of EntreMed, Inc., +1-240-864-2643
Web site: http://www.entremed.com/
