The Phase I/IIa inter-patient dose escalation study will assess the safety and tolerability of repeated administration of Cytheris’s investigative immunotherapy, recombinant human Interleukin-7 (CYT107), as an add-on therapy in the treatment of patients infected with genotype 1 hepatitis C (HCV) and who previously have proven non-responsive to standard treatment. The study will be conducted at four sites, two in Taipei and one each in Tainan and Kaohsiung.
Patients chronically infected with HCV genotype 1 will be assessed for study participation if, based on past treatment history, they are considered resistant to standard bitherapy treatment with peg-IFN and RBV (no EVR at week 12 or HCV RNA detectable at week 24 or week 48).
Standard bitherapy will be initiated in these previously treated ‘non-responder’ HCV infected patients and administered for six to 10 weeks. CYT107 will then be added for a cycle of four weekly subcutaneous injections at defined dose levels while standard bitherapy is continued for nine weeks after CYT107 treatment is discontinued. The duration of the study is approximately 60 weeks, with at least 20-25 weeks of bitherapy.
Michel Morre, president and CEO of Cytheris, said: “In addressing these patients who have failed to respond to the standard interferon-based treatment for HCV, we are confronting a significant unmet medical need faced by people and healthcare systems on a global scale. After failing the standard combination therapy, patients and their physicians are left with virtually no available treatment options that can arrest this silent but nevertheless progressive liver disease.”