ROCKVILLE, Md., Jan. 19 /PRNewswire-FirstCall/ -- EntreMed, Inc. , a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, today announced the commencement of a Phase 2 study for its lead drug candidate, Panzem(R) NCD (2-methoxyestradiol or 2ME2) in patients with recurring glioblastoma multiforme (GBM). The study will be conducted at the Brain Tumor Center at Duke University Medical Center. David A. Reardon, M.D., Medical Director, Clinical Research at the Brain Tumor Center will serve as principal investigator for the study. The purpose of the single center, open-label study will be to assess the safety, pharmacokinetics and efficacy profile of Panzem(R) NCD in patients with GBM who have failed initial therapies. Thirty- two refractory/relapsed GBM patients are expected to be enrolled in the study.
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2ME2 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. Panzem(R) NCD, an oral liquid formulation, has been shown in preclinical studies to significantly increase the drug’s bioavailability and activity and has been shown to result in enhanced drug levels of 2ME2 in patients. Phase 1 studies with Panzem(R) NCD have shown that the pharmacokinetic target for antitumor activity in animals was achieved at a dose of 1000 mg given orally four times each day. Additionally, Panzem(R) NCD had an acceptable toxicity profile at this dose and was associated with stable disease and two minor tumor responses.
Carolyn F. Sidor, M.D., M.B.A, EntreMed Vice President and Chief Medical Officer, commented, “We are pleased to lead off our Panzem(R) NCD Phase 2 program with Dr. Reardon and his team of experts at the Duke Brain Tumor Center, a leading center for treating GBM and other brain tumors. Based on results from both preclinical experiments and mechanism of action studies, we believe that 2ME2 may be particularly well-suited for this patient population because these tumors are highly angiogenic and frequently harbor pten mutations, which result in high levels of HIF-1alpha protein. EntreMed plans to initiate several additional Phase 2 studies in 2006 in various patient populations, including both single agent and combination studies with other approved anticancer therapies.”
For more information on this study, visit the Clinical Trials section of the Company’s web site at http://www.entremed.com.
About Glioblastoma
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.
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 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 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, 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; 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).
Ginny Dunn EntreMed, Inc. Associate Director Corporate Communications & Investor Relations 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/
