On January 30, 2015 Stemline Therapeutics reported that SL-701 has received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of glioma (Press release Stemline Therapeutics, JAN 30, 2015, View Source [SID:1234501432]).
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SL-701 is an enhanced immunotherapy designed to activate the immune system to kill malignant gliomas, which are aggressive malignancies of the brain that arise in both adults and children. A multicenter Phase 2 clinical trial is currently evaluating the antitumor activity of SL-701 in adult patients with second-line glioblastoma multiforme (GBM), a particularly aggressive type of glioma. An earlier version of the therapy demonstrated clinical activity, including durable complete responses (CRs) and partial responses (PRs) as well as prolonged disease stabilizations and an overall survival signal, in both adults and children with malignant glioma.
"We are pleased with the FDA’s decision to grant Orphan Drug designation to SL-701 as it provides Stemline with a number of benefits through development and commercialization of this novel therapy," noted Eric K. Rowinsky, M.D., Stemline’s Chief Medical Officer and Head of Research and Development. He continued, "GBM is a highly aggressive disease with few effective treatment options and remains a major unmet need. Instead of targeting a single component of the cancer, SL-701 is designed to activate and direct the immune system against multiple targets overexpressed on glioma cells. We are very pleased about the high level of interest in the study from patients and clinicians alike."