Cytheris SA has announced the initiation of a Phase I clinical trial of its lead investigational drug candidate, Interleukin-7 (IL-7), also known as CYT107. This new trial will study the use of IL-7 / CYT107 in the treatment of post-transplant patients with T-cell depleted bone marrow or peripheral blood stem cell transplants.
The initial study site will be at Memorial Sloan-Kettering Cancer Center (MSKCC) in New York City, where Marcel R.M. van den Brink, M.D., Ph.D., Head, Division of Hematologic Oncology, and Miguel-Angel Perales, M.D., Assistant Attending Physician in the Bone Marrow Transplant Service, will serve as Principal Investigator and co-Principal Investigator, respectively. Additional study sites are expected to open in the United States during the coming months.
Recombinant human Interleukin-7 (r-hIL-7) is a critical growth factor for immune T-cell recovery and enhancement. Clinical trials conducted on more than 75 patients in Europe, the United States and Canada have suggested the potential of r-hIL-7 to expand and protect CD4+ and CD8+ T-cells. Cytheris is currently conducting multiple international clinical studies of IL-7 in HIV, HCV and cancer.
"We share a commitment with MSKCC to addressing the unmet medical need that exists for cancer patients who are frequently in a profoundly immunodeficient state following the bone marrow transplant procedure, leaving them susceptible to a variety of bacterial, viral, and fungal infections," said Michel Morre, DVM, President and CEO of Cytheris.
"MSKCC has for many years been in the forefront of stem cell transplantation therapy in the U.S. and we are therefore especially pleased that Drs van den Brink and Perales have agreed to participate in this study which we hope will ultimately lead to the development of therapies to prevent post-transplant infections which so often contribute to the failure of hematopoietic stem cell allografts."