25.08.2008 at 08:00
- Category:
Cancer and Oncology
SuperGen, Inc., a pharmaceutical company dedicated to the discovery, rapid development and commercialization of therapies for solid tumors and hematological malignancies, announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for the company's lead drug candidate, MP-470, for the treatment of glioblastoma multiforme (GBM), an often fatal form of brain cancer.
The FDA 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 (IR) 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 1 trials as a single agent and in combination with chemotherapy in patients with solid tumors, and a phase 1b study in patients with GBM is planned.
"Glioblastoma is the most common malignant primary brain tumor, representing approximately 10% of all brain tumors," said Gregory Berk, MD, SuperGen's Chief Medical Officer. "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."
Copyright 2008, Oncology Business Week via NewsRx.com
