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.”