Healthcare Industry News: estradiol
News Release - January 19, 2006
EntreMed Commences Phase 2 Studies with Panzem(R) NCDDuke University Medical Center to Conduct Brain Cancer Trial
ROCKVILLE, Md., Jan. 19 (HSMN NewsFeed) -- 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 study for its lead drug candidate, PanzemŽ 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 PanzemŽ NCD in patients with GBM who have failed initial therapies. Thirty- two refractory/relapsed GBM patients are expected to be enrolled in the study.
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. PanzemŽ 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 PanzemŽ 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, PanzemŽ 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 PanzemŽ 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.
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. PanzemŽ (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.
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