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news.Cytheris has reported interim results from a Phase I clinical trial of its investigational drug candidate, recombinant human Interleukin-7 (CYT107), in the treatment of post-transplant patients with T-cell depleted (TCD) bone marrow or peripheral blood stem cell transplants.
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Preliminary assessment of the immunological effects of CYT107 in 8 evaluable patients showed a median increase in CD4 T cells exhibiting a naïve or central memory phenotype of 69% over baseline.
In addition, there was a median increase in CD8 T cells exhibiting a naïve or effector memory phenotype of 94% over baseline.
The Phase I clinical trial enrolled 9 patients with a median age of 59.3 years, and is being conducted at Memorial Sloan-Kettering Cancer Center (MSKCC), US.
The primary objective of the study is to determine the safety and a recommended dose of CYT107 in patients, and if toxicities are encountered, the study will also seek to establish the maximum tolerated dose (MTD) and dose limiting toxicities (DLT).
Co-principal investigator of the study Miguel-Angel Perales said that delayed and deficient reconstitution of T cell populations together with consequent development of opportunistic infections remains a common cause of transplant failure.
"The interim study results suggest that the administration of CYT107 may represent a new and promising therapeutic pathway leading to enhancement of post-transplant immune recovery in recipients of a T-cell depleted allo-HSCT without causing graft-versus-host disease," Perales said.