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Cytheris Initiates INSPIRE 2, a Phase II Clinical Trial of Recombinant Human Interleukin-7

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Cytheris SA, a clinical stage biopharmaceutical company focused on research and development of new therapies for immune modulation, has announced that it has begun enrolling patients in INSPIRE 2, a Phase IIa clinical program 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 microgram/kg/week in patients with CD4 counts of 101-400 cells/mL. 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 percent 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, MD, 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, MD, 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."

Data from the first INSPIRE study were presented by Yves Levy, MD, PHD [Scientific Director of the French National Agency for Research on AIDS and Viral Hepatitis (ANRS) Vaccine Program, Service d'Immunologie Clinique, Hopital Henri Mondor, Créteil, France and Inserm, Principle Investigator and Co-Chair of the INSPIRE study] during an oral late breaker session at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) held September 12-15, 2009, in San Francisco, CA.

The analysis shows that CYT107 induces a dose dependent and sustained increase of CD4 T-cells, with many patients achieving CD4 counts > 500 cells/mm3. The median CD4 and CD8 T-cell increases per mm3 over baseline, from 240 to 563 (135 percent) and from 659 to 1210 (65 percent), respectively, at the 20mcg/kg dose, suggest the potential of CYT107 to play a significant role in HIV therapy and represent part of the rationale for initiating the INSPIRE 2 study to further explore the immunological properties of CYT107.