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news.The US Food and Drug Administration (FDA) has accepted Stemline Therapeutics’ investigational New Drug (IND) application for SL-701, a synthetic multi-peptide vaccine targeting glioma brain tumours.
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The FDA acceptance enables Stemline Therapeutics to advance SL-701 into a Phase II trial of adults with glioblastoma multiforme (GBM) in first recurrence.
SL-701, a subcutaneously-administered cancer vaccine, is based on a vaccine developed at the University of Pittsburgh. SL-701 has multiple synthetic peptides that are engineered for increased immunoreactivity against targets overexpressed on the cancer stem cells and tumuor bulk of gliomas.
The vaccine developed at the University of Pittsburgh showed single agent clinical efficacy, including complete responses and partial responses in Phase I/II trials conducted by the university in both adults and children with high-grade gliomas, including GBM.
Sponsored by Stemline, the multi-centre study has been designed to evaluate SL-701 in adults with GBM that has recurred following initial treatment with surgery, radiation, and chemotherapy. Co-primary endpoints of the study are overall response rate and survival. The study will enroll 80-100 patients.
Stemline chief medical officer Dr Eric Rowinsky noted the company is very excited to be opening its first of two expected INDs in 2014.
"If the data generated by our SL-701 study are in-line with the results of earlier studies, we intend to work with the regulatory authorities towards registration and commercialization.
"In addition to SL-701, our other clinical program, SL-401, a targeted therapy directed to the interleukin-3 receptor which is overexpressed on CSCs and tumor bulk of a wide range of hematologic malignancies, is also on track for IND filing and initiation of studies this year," Dr Rowinsky added.