Stemline Therapeutics Announces Clinical Trial Results With SL-701, a Phase 2 Therapeutic for High-Grade Glioma, in an Additional Indication: Data to be Presented at the Society of Neuro-Oncology (SNO) Annual Meeting

NEW YORK, Nov. 19, 2013 (GLOBE NEWSWIRE) -- Stemline Therapeutics, Inc. (Nasdaq:STML) announced today that clinical trial results of SL-701, a Phase 2 therapeutic entering registration-directed studies in high-grade glioma (HGG), in an additional indication, low-grade glioma (LGG), will be presented by investigators from the University of Pittsburgh at the 4th Quadrennial Meeting of the World Federation of Neuro-Oncology (WFNO) being held in conjunction with the 18th Annual Society for Neuro-Oncology (SNO) meeting in San Francisco, California on November 21-24, 2013. SL-701 is a subcutaneously-administered cancer vaccine comprised of multiple synthetic peptides corresponding to targets on tumor bulk and cancer stem cells (CSCs).

SL-701 has previously demonstrated single-agent clinical efficacy, including complete responses (CRs), in Phase 1/2 trials in both adults and children with high-grade glioma (HGG), including glioblastoma multiforme (GBM). Based on these results, Stemline is undertaking registration-directed programs in both adults and children with HGG. At the SNO meeting, University of Pittsburgh investigators will report on the safety and immunological responses achieved with SL-701 in an additional indication, adults with newly diagnosed or recurrent low-grade glioma (LGG) (n=23). SL-701 was determined to be well-tolerated and induced specific and sustained immune responses against its brain tumor targets. Further, patients with a high magnitude of immunologic responsiveness experienced prolonged progression free survival (PFS).

Eric Rowinsky, M.D., Chief Medical Officer and Head of Research and Development of Stemline, commented, "We have previously reported robust single-agent efficacy, including CRs, in Phase 1/2 trials of adults and children with advanced HGG, including glioblastoma. In addition, these most recent results, in which immunologic responsiveness correlated with PFS in LGG, further supports SL-701's potential to have a major impact in the treatment of multiple different types of brain cancer. Our immediate plans now are to advance SL-701 into late-stage trials in HGG, including a potentially accelerated approval pathway in adults with second-line GBM, and in children with brainstem and non-brainstem glioma for which there are no approved therapies. We will also continue to monitor the ongoing Pittsburgh trial in LGG, another area of unmet medical need, and consider advancement in this indication as well."

Details on the presentation are as follows:

Robust induction of type-1 CD8+ T-cell responses in WHO grade II low-grade glioma patients receiving peptide-based vaccines (SL-701) in combination with poly-ICLC (IT-013)

Presenter: Hideho Okada, M.D., Ph.D., Professor of Professor of Neurological Surgery, Surgery and Immunology, University of Pittsburgh Cancer Institute, Pittsburgh, PA.

Date/Time: Saturday, November 23, 2013; 5:00-7:00 pm PT

About Stemline Therapeutics, Inc.

Stemline Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing novel oncology therapeutics that target both cancer stem cells (CSCs) as well as the tumor bulk. Stemline's clinical candidates, SL-401 and SL-701, have demonstrated clinical activity, including durable complete responses (CRs), in Phase 1/2 studies of patients with advanced hematologic and brain cancer, respectively. SL-401 is being advanced into pivotal programs in blastic plasmacytoid dendritic cell neoplasm (BPDCN) and third-line acute myeloid leukemia (AML) as well as other clinical studies in additional hematologic cancers. SL-701 is being advanced into later stage trials of adults with second-line glioblastoma multiforme (GBM) and children with brainstem and non-brainstem glioma. For more information about Stemline Therapeutics, visit www.stemline.com.

Forward-looking statements:

Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The factors that could cause our actual results to differ materially are identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not intend to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

CONTACT: Mark Jacobson Director, Corporate Development Stemline Therapeutics, Inc. 750 Lexington Avenue Eleventh Floor New York, NY 10022 Tel: 646-502-2307 Email: mjacobson@stemline.comSource:Stemline Therapeutics, Inc.