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EntreMed Granted Orphan Drug Designation for Panzem(R) (2ME2) In Glioblastoma
2006 June 28 , PRNewswire
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.
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.
SOURCE EntreMed, Inc.