Cytheris Announces Initiation of NIAID/NIH-Sponsored Phase I/IIa Clinical Trial of Interleukin-7
News Oct 29, 2009
Cytheris SA has announced the initiation of a Phase I/IIa dose escalation study of patients suffering from idiopathic CD4 lymphocytopenia (ICL). ICL is a rare, orphan disease characterized by abnormally low CD4 T cell counts without evidence of human immunodeficiency virus (HIV-1 or HIV-2) infection.
The trial is a further investigation of Cytheris' promising investigative immunotherapy, CYT107 (recombinant human interlukin-7, or IL-7), already the subject of six other studies for different indications.
The study is sponsored, conducted and partially funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH). Under the direction of Irini Sereti, M.D., M.H.S., NIAID/NIH Study Investigator, the trial is designed to assess the safety and biological effects of repeated administration of CYT107 and will be conducted at the NIH Clinical Center in Bethesda, Maryland, the largest US hospital devoted entirely to clinical research.
"Since its inception in 1999, Cytheris has had a close relationship with IL-7 investigators at the US National Institutes of Health, a connection that has played a pivotal role in bringing the potential of this cytokine to the attention of the medical community," said Michel Morre, DVM, President and CEO of Cytheris. "We are very pleased that NIH has again recognized the value of the IL-7 program and has chosen to provide financial support as well as the participation of NIAID investigators in this clinical development program focused on ICL."
The trial is called ICICLE (Interleukin-7 (CYT107) Treatment of Idiopathic CD4 Lymphocytopenia: Expansion of CD4 T Cells). It is a Phase I/IIa open-label, single arm clinical trial evaluating the safety profile of glycosylated recombinant human interleukin-7 (rhIL-7) as an immune modulator in patients with ICL at risk of disease progression. Secondary analyses will assess the immunostimulatory effects of rhIL-7 on T cell numbers and function.
"ICL patients have a propensity to develop serious co-morbidities and the dearth of treatment options for their primary lymphocytopenia, particularly in patients who have experienced opportunistic or otherwise serious infections, means that the unmet medical need to establish novel immune treatments for ICL patients persists," said Therese Croughs, MD, Chief Medical Officer of Cytheris.
"IL-7 represents a promising investigative therapy which has shown in pre-clinical and Phase I studies in oncology and in HIV-infected patients to be well tolerated in repeated dose trials, with long-lasting increases in both CD4 and CD8 T cells."