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Stemline Therapeutics Inc announces FDA acceptance of IND for SL-701, Synthetic Multi-Peptide Vaccine Targeting Glioma Brain Tumors

Tuesday, 8 Apr 2014 07:00am EDT 

Stemline Therapeutics Inc:US FDA has accepted company's Investigational New Drug (IND) application for SL-701, which enables company to advance SL-701 into a Phase 2 trial of adults with glioblastoma multiforme (GBM) in recurrence.SL-701 is 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, most common type of brain cancer.It is based on vaccine developed at University of Pittsburgh that demonstrated single agent clinical efficacy, including complete responses (CRs) and partial responses (PRs), in Phase 1/2 trials conducted by university in both adults and children with high-grade gliomas, including GBM.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 chemother.Overall response rate and survival are co-primary endpoints. 

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26 Dec 2014