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news.SuperGen has announced that the FDA has granted orphan drug designation for the company's lead drug candidate, MP-470, for the treatment of glioblastoma multiforme, an often fatal form of brain cancer.
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The FDA has accepted SuperGen’s application upon review of data from in vitro studies in glioblastoma cell lines that demonstrate that either MP-470 or ionizing radiation alone induce cell death, but when used in combination they synergistically increase cell death by more than two-fold over either agent alone.
MP-470 is currently being evaluated in Phase I trials as a single agent and in combination with chemotherapy in patients with solid tumors, and a Phase Ib study in patients with glioblastoma multiforme (GBM) is planned.
Gregory Berk, chief medical officer of SuperGen, said: “This designation not only underscores the need for improved therapies in GBM, it also underscores the company’s development strategy in pursuing areas of unmet need.”