US drug developer EntreMed says that its lead product candidate, Panzem (2-methoyestradiol), has been granted Orphan Drug status by the Food and Drug Administration for the treatment of the brain cancer, glioblastoma multiforme. The agency's decision was based on its review of data from in vitro glioma cell line studies, in which the drug demonstrated antiproliferative activity.
Carolyn Sidor, EntreMed's vice president and chief medical officer, said that the firm's preclinical and clinical work indicates that 2ME2 has efficacy against gliblastoma. She added that the drug has also been granted Orphan Drug designation for use in multiple myeloma and ovarian cancer.
In January this year, EntreMed began a Phase II study of the drug in glioblastoma patients at the Brain Tumor Center at the Duke University Medical Center in North Carolina.
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