FDA OKs Stemline Therapeutics' IND Application For SL-701 - Quick Facts

(RTTNews) - The U.S. Food and Drug Administration or FDA has accepted Stemline Therapeutics, Inc.'s (STML) Investigational New Drug application or IND for SL-701, a synthetic multi-peptide vaccine targeting Glioma Brain Tumors.

SL-701 is a subcutaneously-administered cancer vaccine used for increased immunoreactivity against targets over expressed on the cancer stem cells and tumor bulk of gliomas, the most common type of brain cancer.

This approval enables the firm to advance SL-701 into a Phase 2 trial of adults with glioblastoma multiforme or GBM in first recurrence. The 80-100 patient multi-center study will assess SL-701 in adults with GBM that has recurred, following initial treatment with surgery, radiation, and chemotherapy, with overall response rate and survival as the co-primary endpoints.

Eric Rowinsky, MD, Stemline's Chief Medical Officer, commented: " 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." He added, "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."