Cytheris SA is committed to developing innovative immuno therapies that will treat unmet medical needs. In doing so, we first conduct lengthy preclinical studies to confirm the anticipated effects and necessary safety margin.
After preclinical studies have been completed, we carry out a series of clinical studies approved by regulatory authorities and ethics committees. These studies are designed to evaluate each investigational drug to determine how it acts and whether it is safe and effective in the target human population. All data are provided to the regulatory authorities for their review before initiating additional clinical investigations. We conduct all clinical trials worldwide to the highest medical and ethical standards and according to Good Clinical Practice and with the oversight of institutional ethics committees and review boards.
Cytheris posts protocol information on most company-sponsored clinical studies to the National Institutes of Health's (NIH) ClinicalTrials.gov website. To learn more about Cytheris clinical trial protocols and patient eligibility or to find out if a study is enrolling patients in your area, please visit www.clinicaltrials.gov.
Summary information on each trial can be found in the Clinical Trials section of this website.
Our current clinical trials are shown in the following table:
| Clinical Trials | Title | Country | Study Details |
|---|---|---|---|
| ONCOLOGY | |||
| CLI-107-04 | A Phase I Study of Subcutaneous “Cyt107” (Glycosylated Recombinant Human Interleukin-7) in Patients with Refractory Metastatic Melanoma or Advanced Renal Cell Carcinoma | United States | Clinical Trials.gov |
| NCI-sponsored vaccine study | A Pilot Study of Tumor Vaccination and rhIL-7 Following Standard Multimodality Therapy in Patients with High Risk Pediatric Solid Tumors and Altered T Cell Homeostasis. | United States | |
| HIV | |||
| CLI-107-06 Trial Name: INSPIRE |
A Phase I/IIa Randomized Placebo Controlled, Single-Blind Multicenter Dose-Escalation Study of Subcutaneous Intermittent Interleukin-7 CYT107 in Chronically HIV-Infected Patientswith CD4 T-Lymphocyte Counts Between 101-400 Cells/Mm3 and Plasma HIV RNA< 50 copies/mL after at Least 12 Months of HAART | United States Canada France Italy |
Clinical Trials.gov |
| CLI-107-13 Trial Name: INSPIRE 2 |
A Phase IIa Open-Label, Multicenter Study of Subcutaneous Intermittent Recombinant Interleukin-7 (CYT107) in Chronically HIV-infected Patients with CD4 T Lymphocyte Counts Between 101-400 cells/mm3 and Plasma HIV RNA< 50 copies/mL After at Least 12 Months of HAART. | United States Canada |
|
| HBV | |||
| CLI-107-10 Trial Name: CONVERT |
Phase I/IIa Randomized Open Label Controlled Dose Escalation Study of Repeated Administration of “CYT107” (glyco-r-hil-7) Added on Antiviral Treatment and Vaccination in HBeAG-Negative Chronic Hepatitis B-Infected Patients | France Italy |
Clinical Trials.gov |
| HCV | |||
| CLI-107-05 Trial Name: ECLIPSE 1 |
A Phase I Dose Escalation Study of Repeated Administration of “CYT107” (glyco-r-hIL-7) Add On Treatment in Genotype 1 HCV Infected Patients Resistant to 12 Weeks Peg-Interferon-Alpha / Ribavirin | Switzerland France Italy |
Clinical Trials.gov |
| CLI-107-07 Trial Name: ECLIPSE 2 |
A Phase I/IIa Dose Escalation Study of Repeated Administration of “CYT107” (glyco-r-hIL-7) Add On Treatment in Genotype 1 or 4 HCV Infected Patients Resistant To Pegylated Interferon-Alpha and Ribavirin |
Switzerland France Italy |
Clinical Trials.gov |
| CLI-107-09 Trial Name: ECLIPSE 3 |
A Phase I/IIa Dose Escalation Study in Asia of Repeated Administration of “CYT107” (glyco-r-hIL-7) Add On Treatment in Genotype 1 HCV Infected Patients Resistant To Pegylated Interferon-Alpha and Ribavirin | Taiwan | Clinical Trials.gov |
| BMT | |||
| CLI-107-08 | A Phase I Study of CYT107 (Recombinant Glycosylated Human IL-7) in Recipients of HLA Matched Ex Vivo T cell Depleted Bone Marrow or Peripheral Blood Stem Cell Transplant | United States | Clinical Trials.gov |
| Idiopathic CD4 lymphocytopenia (ICL) | |||
| ICICLE | A Phase I/IIa open-label, single arm clinical trial evaluating the safety profile of glycosylated recombinant human interleukin-7 (rhIL-7) as an immune modulator in patients with ICL at risk of disease progression. | United States | Clinical Trials.gov |