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Stemline Therapeutics, Inc. (STML) Announces FDA Acceptance Of IND For SL-701, A Synthetic Multi-Peptide Vaccine Targeting Glioma Brain Tumors


4/8/2014 7:39:18 AM

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NEW YORK, April 8, 2014 (GLOBE NEWSWIRE) -- Stemline Therapeutics, Inc. (Nasdaq:STML) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company's Investigational New Drug (IND) application for SL-701, which enables the company to advance SL-701 into a Phase 2 trial of adults with glioblastoma multiforme (GBM) in first recurrence. SL-701 is a subcutaneously-administered cancer vaccine comprised of multiple synthetic peptides engineered for increased immunoreactivity against targets overexpressed on the cancer stem cells (CSCs) and tumor bulk of gliomas, the most common type of brain cancer. It is based on a vaccine developed at the University of Pittsburgh that demonstrated single agent clinical efficacy, including complete responses (CRs) and partial responses (PRs), in Phase 1/2 trials conducted by the university in both adults and children with high-grade gliomas, including GBM. The Stemline-sponsored trial is an 80-100 patient multi-center study, designed to evaluate SL-701 in adults with GBM that has recurred following initial treatment with surgery, radiation, and chemotherapy. Overall response rate and survival are co-primary endpoints.

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