Cytheris Initiates INSPIRE 3, a Phase II Clinical Trial of CYT107 in Chronically Infected HIV Patients
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Cytheris SA has announced that it has begun enrolling patients in INSPIRE 3, a Phase II clinical program evaluating the effect of repeated cycles of 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 24 months of highly active anti-retroviral therapy (HAART). The study will enroll a total of 80 patients at investigative sites in Italy, Switzerland and South Africa.
“We are pleased to announce that the INSPIRE 3 clinical program is underway. The repeated treatment cycles of CYT107 in this study mimic the way the product will be used in the clinical setting and should trigger an improved and more prolonged immune reconstitution, a stabilization of patient CD4+ T cell counts above 500/microliter, and a decrease of the markers of activation/inflammation,” said Michel Morre, DVM, President and CEO of Cytheris. “The safety and efficacy results obtained in this trial will contribute to the clinical profile of CYT107 as a potentially important new option for HIV patients and will also serve to define the clinical end points in subsequent pivotal therapeutic studies.”
The Phase II study is designed to evaluate the safety and biological activity of CYT107 at a dose of 20 microgram/kg/week in patients with CD4+ T cell counts which have remained between 101-350 cells/microliter after at least 2 years of HAART and with plasma HIV RNA less than 50 copies/milliliter for 18 months.
Numerous large cohort studies have shown that the health status and life expectancy of HAART-treated HIV patients able to recover and maintain their CD4+ T cell counts above 500/microliter is comparable to the healthy population.
In particular these patients show a lower incidence of AIDS-related or non-AIDS-related malignancies, opportunistic infections and cardiovascular events compared to the HIV-infected population with CD4+ T cell counts below 500/microliter.
“In the INSPIRE 3 trial the goal is to establish the safety and biological activity of repeated cycles of CYT107 administered in a way that will optimize the chances that INR patients will be able to remain above 500 CD4+ T cells/microliter during the study period,” said Giuseppe Tambussi, MD, Head, Experimental Therapies Unit, Infectious Disease Clinic, San Raffaele Hospital, Milan, Italy, and Principal Investigator/Study Chairman for the trial. “This is a key prerequisite for undertaking studies aimed at demonstrating the clinical efficacy of such a therapeutic regimen.”
“We are pleased to announce that the INSPIRE 3 clinical program is underway. The repeated treatment cycles of CYT107 in this study mimic the way the product will be used in the clinical setting and should trigger an improved and more prolonged immune reconstitution, a stabilization of patient CD4+ T cell counts above 500/microliter, and a decrease of the markers of activation/inflammation,” said Michel Morre, DVM, President and CEO of Cytheris. “The safety and efficacy results obtained in this trial will contribute to the clinical profile of CYT107 as a potentially important new option for HIV patients and will also serve to define the clinical end points in subsequent pivotal therapeutic studies.”
The Phase II study is designed to evaluate the safety and biological activity of CYT107 at a dose of 20 microgram/kg/week in patients with CD4+ T cell counts which have remained between 101-350 cells/microliter after at least 2 years of HAART and with plasma HIV RNA less than 50 copies/milliliter for 18 months.
Numerous large cohort studies have shown that the health status and life expectancy of HAART-treated HIV patients able to recover and maintain their CD4+ T cell counts above 500/microliter is comparable to the healthy population.
In particular these patients show a lower incidence of AIDS-related or non-AIDS-related malignancies, opportunistic infections and cardiovascular events compared to the HIV-infected population with CD4+ T cell counts below 500/microliter.
“In the INSPIRE 3 trial the goal is to establish the safety and biological activity of repeated cycles of CYT107 administered in a way that will optimize the chances that INR patients will be able to remain above 500 CD4+ T cells/microliter during the study period,” said Giuseppe Tambussi, MD, Head, Experimental Therapies Unit, Infectious Disease Clinic, San Raffaele Hospital, Milan, Italy, and Principal Investigator/Study Chairman for the trial. “This is a key prerequisite for undertaking studies aimed at demonstrating the clinical efficacy of such a therapeutic regimen.”
