The study is expected to recruit a total of 80 patients at investigative sites in Italy, Switzerland and South Africa.
CYT107 Phase II study is designed to evaluate the safety and biological activity of the drug at a dose of 20microgram/kg/week in patients with CD4+ T cell counts which have remained between 101-350cells/microliter after at least 2 years of HAART and with plasma HIV RNA less than 50copies/milliliter for 18 months.
Cytheris DVM, president and CEO Michel Morre said that the repeated treatment cycles of CYT107 in this study mimic the way the product would be used in the clinical setting and should trigger an improved and more prolonged immune reconstitution, a stabilisation of patient CD4+ T cell counts above 500/microliter, and a decrease of the markers of activation/inflammation.
“The safety and efficacy results obtained in this trial will contribute to the clinical profile of CYT107 as an important new option for HIV patients and will also serve to define the clinical end points in subsequent pivotal therapeutic studies,” Morre said.