Cytheris SA, a clinical stage biopharmaceutical company focused on
research and development of new therapies for immune modulation, today
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 µg/kg/week in patients with CD4 counts of 101-400
cells/µL. The study will be conducted across 4 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”
“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% 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.