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Cytheris initiates new Phase I bone marrow transplant study

Biopharmaceutical firm Cytheris has started a Phase I clinical trial of its lead investigational drug candidate, Interleukin-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.

The primary objective of the investigation is to determine the safety and a recommended dose of CYT107 in recipients of an HLA-matched related or unrelated ex vivo T-cell-depleted bone marrow or peripheral blood stem cell transplant after initial engraftment and hematopoietic reconstitution. If toxicities are encountered, the study will also seek to establish the maximum tolerated dose and dose limiting toxicities.

Michel Morre, president and CEO of Cytheris, said: “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.”