ROCKVILLE, Md., June 28 /PRNewswire-FirstCall/ -- EntreMed, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for the Company’s lead drug candidate, 2-methoxyestradiol (2ME2 or Panzem(R)), for the treatment of glioblastoma multiforme (GBM), an often fatal form of brain cancer.
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The FDA accepted EntreMed’s application upon review of data from in vitro studies in glioma cell lines that demonstrate the antiproliferative activity of 2ME2. Additionally, results from in vivo studies in a preclinical model of glioblastoma demonstrate antitumor activity of 2ME2. In January 2006, EntreMed initiated a Phase 2 study in patients with glioblastoma multiforme at the Brain Tumor Center at Duke University Medical Center.
Carolyn F. Sidor, M.D., EntreMed Vice President and Chief Medical Officer commented on the designation, “Glioblastoma is the most common malignant primary brain tumor representing approximately 12 to 15% of all 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. We have now received orphan drug designation for 2ME2 (Panzem(R)) in three cancer indications.”
Orphan drug is a designation by the Food and Drug Administration indicating a therapy developed to treat diseases that affect fewer than 200,000 persons in the United States. Sponsors of drugs granted orphan designation qualify for tax credit and marketing exclusivity incentives of the Orphan Drug Act. EntreMed received orphan drug designation previously for 2ME2 in the treatment of multiple myeloma (a type of blood cancer) and ovarian cancer.
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 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 metastatic breast 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, 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; 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: Mark Williamson, Sr. Communications, Specialist of EntreMed, Inc., +1-240-864-2645.
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CONTACT: Mark Williamson, Sr. Communications, Specialist of EntreMed,Inc., +1-240-864-2645
Web site: http://www.entremed.com//
