Patients Approach Two Years of Complete HIV Viral Load Suppression in Phase 2b PRO 140 Monotherapy Extension Study
GlobeNewswire
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CytoDyn Inc
VANCOUVER, Washington, Aug. 23, 2016 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB:CYDY), a biotechnology company focused on the development of new antibody therapies for combating human immunodeficiency virus (HIV) infection, announces that the first of 11 HIV-1 patients receiving PRO 140 as a monotherapy in a Phase 2b extension study has reached two years of complete virologic suppression. Four additional patients are expected to reach the two-year benchmark in the next three weeks and five more patients are expected to reach this benchmark in approximately two months.
“We are pleased that 10 HIV patients who participated in our Phase 2b study are approaching the significant milestone of two years of complete virologic suppression on PRO 140 as a single agent,” said Nader Pourhassan, PhD, CytoDyn’s President and CEO. “These patients are receiving weekly subcutaneous PRO 140 injections as a substitution for daily regiments of Highly Active Antiretroviral Therapy (HAART) regimens without the notable drawbacks of HAART.”
Patients in the Phase 2b extension study showed full HIV viral load suppression during a 12-week Phase 2b study in which they receive weekly PRO 140 subcutaneous injections (one 350 mg dose) in place of their HAART regimens. Forty patients were enrolled in the Phase 2b trial, of which 35 were evaluable and five were excluded for tropism screening failures or protocol violations. Twenty patients completed the 12-week Phase 2b study with HIV viral load suppression and were eligible for the extension arm. Fifteen patients of the 20 were granted entry into the extension arm. Four of the fifteen patients that entered the extension arm were disqualified due to lack of follow-up (relocation) or disqualification unrelated to PRO 140 and one was a treatment failure, leaving 10 evaluable patients, which are now at or close to the two-year benchmark of complete HIV viral load suppression while on PRO 140 as a monotherapy.
Of the 11 patients currently receiving weekly PRO 140 injections in the Phase 2b extension study, one patient recently entered the study, having shown complete HIV viral load suppression following an initial 12-week treatment period. This patient was one of three patients who were allowed to qualify for the Phase 2b extension study within the past two to four months by the trial’s Data Safety Monitoring Board due to the disqualification of three patients in the original Phase 2b study for tropism screening errors.
Patients qualifying for the Phase 2b monotherapy study were evaluated for infection with strains of HIV-1 that utilize the CCR5 co-receptor. The PRO 140 monoclonal antibody targets CCR5 with high affinity and potently blocks HIV-1 cell entry. Complete virologic suppression is defined as plasma HIV-1 RNA less than 40 copies/mL, which is the lower limit of detection in the commercial assay. Blood drawn after one year of monotherapy from nine patients in the Phase 2b extension study were tested with a single copy HIV-1 research test. In six of the nine patients whose viral load was checked with a single copy assay, the viral load was documented to be less than one HIV-1 RNA copy/mL blood and two patients had less than 4 copies/mL.
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