Cytheris SA, a clinical stage biopharmaceutical company focused on research and development of new therapies for immune modulation, has begun enrolling patients in Inspire 2, a phase-IIa clinical programme evaluating the company’s investigative immune-modulator, recombinant human Interleukin-7 (CYT107), in the treatment of chronically HIV-1 infected patients classified as Immunological Non Responders (INR) after at least 12 months of highly active anti-retroviral therapy (HAART). The phase-IIa study is designed to evaluate the biological activity and pharmacokinetic (PK) profile of CYT107 at a dose of 20 µg/kg/week in patients with CD4 counts of 101-400 cells/µL. The study will be conducted across four investigative sites in the United States and Canada.
“In most HIV patients, the first year of HAART therapy effectively suppresses viral replication but does not result in restoration and maintenance of CD4 T-cell counts above 500 cells/mm3, the threshold accepted as indicative of sufficient immune reconstitution in this patient population,” said Michel Morre, DVM, president and CEO of Cytheris. “In fact, some 30 per cent of these patients will never achieve the 500 cells/mm3 level even after years of HAART treatment.”
As demonstrated in large patient cohorts, the risk of disease progression or death in patients who remain below the 500 cells/mm3 level is significantly higher when compared to patients who achieve an optimal T-cell restoration with CD4>500 cells/mm3. INSPIRE 2 is being launched to confirm the unique ability of CYT107 to trigger and support immune reconstitution in these patients as already documented in the first INSPIRE study.
“We anticipate that we will see substantial increases in circulating CD4 T cell counts in patients whose CD4 T-cell counts were not restored to normal levels despite complete control of HIV replication under HAART,” said Michael M Lederman, the Scott R Inkley professor of Medicine at Case Western Reserve University, Cleveland, Ohio, Associate Director, CWRU/UHC Center for AIDS Research, and Principal Investigator- Coordinator/Study Chairman for the trial.
"This phase-IIa confirmatory study is designed to further demonstrate the biological activity of CYT107 and provide data that will help in the design of phase IIb/III trials," said Thérèse Croughs, chief medical officer of Cytheris, "The study objectives include characterization of CYT107 pharmacokinetics and pharmacodynamics in patients with moderate to severe lymphopenia, delineation of the relationship between CYT107 dose and biological activity, and confirmation of the relevance of the treatment schedule evaluated in the first INSPIRE study reported on at the recent ICAAC
meeting."
Recombinant human interleukin-7 (CYT107) is a critical immune-modulator for immune T-cell recovery and enhancement.
Cytheris SA is a privately held clinical-stage biopharmaceutical company focused on research and development of new therapies for immune modulation.