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CytoDyn Announces Significantly Improved Response Rate at Higher Dose of PRO 140 in HIV Phase 3 Monotherapy Trial
33 minutes agoGlobeNewswire
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Response rate increases from 40% at 350 mg dose to approximately 70% at 525 mg
IRB approves monotherapy protocol modified to include 700 mg dose
PRO 140 monotherapy, if approved, will allow patients to self-administer once per week at home without need for daily pills
VANCOUVER, Washington, July 30, 2018 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), a biotechnology company developing a novel humanized CCR5 monoclonal antibody for multiple therapeutic indications, announces clearance from the independent Institutional Review Board (IRB) overseeing its CD03 Phase 3 investigative monotherapy trial to increase the weekly PRO 140 dose from 525 mg to 700 mg for newly enrolled patients. Current participants in the trial who failed to maintain suppressed HIV viral load on a lower dose of PRO 140 will be permitted to continue in the trial with a higher dose. The objective of this trial is to assess the efficacy, safety and tolerability of PRO 140 as a long-acting, single-agent maintenance therapy for the chronic suppression of HIV.
“This IRB decision is exciting for patients, our Company and our shareholders, given the potential for a higher patient response rate with PRO 140 as a single agent at the 700 mg dose level,” said Nader Pourhassan, Ph.D., CytoDyn’s president and chief executive officer. “Approximately 70% of trial participants who started with PRO 140 at the 525 mg dose and have been treated between one and nine months are achieving HIV viral load suppression. This response rate is very promising and we are excited to evaluate PRO 140 at an even a higher dose.”
Dr. Pourhassan noted that the exact response rates for PRO 140 at 525 mg could vary as the trial progresses. To date, there has been a clear distinction between patient response rates with PRO 140 at the lower 350 mg and higher 525 mg doses. CytoDyn believes that dosing PRO 140 at the 700 mg dose has the potential to achieve an even higher response rate than the approximate 70% currently observed at the 525 mg dose.
“We are able to increase the dose of PRO 140 due to its positive safety profile in prior clinical trials,” Dr. Pourhassan commented. “That was among the important factors considered by the IRB in providing this clearance.”
Patients enrolled in the Phase 3 monotherapy trial were prescreened for CCR5-tropic HIV-1 infection and suppressed HIV viral load under an existing highly active antiretroviral therapy (HAART) regimen. CytoDyn initiated the trial treating patients with weekly PRO 140 at 350 mg and found that approximately 40% were able to maintain suppressed HIV viral load. Following treatment of the first 150 patients, the protocol was revised to increase the weekly dose of PRO 140 to 525 mg. Patients who were non-responders to PRO 140 at the 350 mg dose were given the opportunity to switch to the higher 525 mg dose, and a majority were able to re-suppress with the higher dose.
“We were pleased that more than 20 patients achieved re-suppressed HIV viral load on PRO 140 525 mg dose after failing the lower PRO 140 350 mg dose and were able to continue in the trial,” said Dr. Pourhassan. “Also of note, patients who achieve suppressed HIV viral load after 10 weeks tend to maintain suppressed viral load. Interestingly, some patients in our Phase 2b extension study are now achieving suppressed HIV viral load for nearly four years with PRO 140 as a single agent.”
“Of key importance in the Phase 3 monotherapy trial, all non-responders to PRO 140 have safely achieved suppressed HIV viral load upon returning to their prior HAART regimens before PRO 140 monotherapy,” said Jacob Lalezari, M.D., Director of Quest Clinical Research, Assistant Clinical Professor of Medicine at UCSF/Mount Zion Hospital and principal investigator of CytoDyn’s Phase 2 monotherapy trial. “This is a major achievement as patients continue to have options for maintaining HIV viral load sup
