Initiation of Phase I/IIa clinical trial of IL-7 announced

Cytheris SA, a clinical stage biopharmaceutical company focused on research and development of new therapies for immune modulation, today announced the initiation of a Phase I/IIa clinical trial of IL-7 in support of tumor lysate/KLH pulsed dendritic cell vaccines in a pilot study of tumor vaccination in patients with metastatic or recurrent pediatric solid tumors and altered T cell homeostasis, including patients with Ewing’s sarcoma family of tumors (ESFT), rhabdomyosarcoma, neuroblastoma, synovial cell sarcoma, desmoplastic small round cell tumor, undifferentiated sarcoma, and embryonal sarcoma.

The trial, “A Pilot Study of Tumor Vaccination and rhIL-7 Following Standard Multimodality Therapy in Patients with High Risk Pediatric Solid Tumors and Altered T Cell Homeostasis”, is a further investigation of Cytheris’ promising investigative immunotherapy, CYT107 (recombinant human interlukin-7, or IL-7), already the subject of seven other studies for different indications.

“This is one of several IL-7 oncology trials conducted with support from NIH that enables Cytheris to continue its longstanding collaboration with NCI investigators,” said Michel Morre, DVM, President and CEO of Cytheris. ”We are hopeful that studies such as this will demonstrate the role of CYT107 as an enhancer of therapeutic vaccines in cancer and, potentially, in chronic viral diseases as well.”

The study is sponsored, conducted and partially funded by the National Cancer Institute (NCI), part of the US National Institutes of Health (NIH). Under the direction of Crystal L. Mackall, M.D., Chief of the Pediatric Oncology Branch and Head of the Immunology Section at NCI, the trial is designed to determine whether immune responses to tumor lysates can be induced in lymphopenic patients with specific types of pediatric solid tumors by combining immunotherapy consisting of autologous lymphocyte infusions depleted of regulatory T cells (Tregs) with tumor lysate/keyhole limpet hemocyanin (lysate/KLH) pulsed dendritic cell (DC) vaccination.

"Despite low overall survival rates, many patients with the kinds of solid tumors represented in this study sustain a very good partial or complete response to standard multimodality therapy comprising multiagent chemotherapy and radiation therapy and/or surgery,” said Thérèse Croughs, MD, Chief Medical Officer of Cytheris. “This protocol will seek to add CYT107 in support of immunotherapy following completion of frontline therapy for patients with primary metastatic disease and following best salvage therapy for patients with recurrent disease in an effort to develop improved outcomes for disease states in which <20% of patients with clinically apparent metastatic disease at presentation are cured.”