CytoDyn’s Monotherapy Trial with Leronlimab (PRO 140) Reaches its Ultimate Goals
New data shows 525 mg dose achieves 95% response rate after the first 10 weeks of monotherapy with leronlimab
Over 110 patients have reached almost one year of suppressed viral load with monotherapy on original dose of 350 mg or higher dosages
Half-life of leronlimab is now confirmed at approximately 10 days versus the previous understanding of approximately 3 days
VANCOUVER, Washington, May 06, 2019 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”) a late stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, today provided an update on leronlimab (PRO140) as a single agent for maintenance of HIV viral load suppression (HIV-1 RNA < 50 copies/mL).
The latest investigative monotherapy trial has revealed sufficient data to more precisely design the pivotal Phase 3 monotherapy trial that CytoDyn plans to use as the basis for label expansion after the potential approval of leronlimab (PRO140) for HIV patients as a combination therapy with HAART. The longer half-life of leronlimab may help to reduce the number of non-responders in the first ten weeks of monotherapy, if the treatment overlaps with existing regimen of leronlimab for four weeks before initiating monotherapy. Under the current trial protocol, patients have 7 days of overlap with their HAART regimen and leronlimab before initiating monotherapy. Based upon these new findings, the overlap period will be 4 weeks for the pivotal trial protocol. In addition, the latest clinical data demonstrates that the 525 mg dose is no less efficacious than 700 mg, which may potentially offer significant value to patients, payors and providers.
“We are excited to now have this new clinical data that enables us to more precisely design the protocol for our planned pivotal monotherapy trial with leronlimab (PRO140),” said Dr. Nader Pourhassan, Ph.D., CytoDyn President and CEO. “If successful, the pivotal monotherapy trial with leronlimab (PRO140) will hopefully generate the high-quality clinical data needed to underpin a successful potential label expansion, should the FDA approve our first BLA for leronlimab (PRO140) as a combination therapy,” continued Dr. Pourhassan. “We have already filed the first of three parts of the BLA for leronlimab (PRO140) as a combination therapy with HAART for HIV,” concluded Dr. Pourhassan.
New data shows 525 mg dose achieves 95% response rate after the first 10 weeks of monotherapy with leronlimab
Over 110 patients have reached almost one year of suppressed viral load with monotherapy on original dose of 350 mg or higher dosages
Half-life of leronlimab is now confirmed at approximately 10 days versus the previous understanding of approximately 3 days
VANCOUVER, Washington, May 06, 2019 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”) a late stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, today provided an update on leronlimab (PRO140) as a single agent for maintenance of HIV viral load suppression (HIV-1 RNA < 50 copies/mL).
The latest investigative monotherapy trial has revealed sufficient data to more precisely design the pivotal Phase 3 monotherapy trial that CytoDyn plans to use as the basis for label expansion after the potential approval of leronlimab (PRO140) for HIV patients as a combination therapy with HAART. The longer half-life of leronlimab may help to reduce the number of non-responders in the first ten weeks of monotherapy, if the treatment overlaps with existing regimen of leronlimab for four weeks before initiating monotherapy. Under the current trial protocol, patients have 7 days of overlap with their HAART regimen and leronlimab before initiating monotherapy. Based upon these new findings, the overlap period will be 4 weeks for the pivotal trial protocol. In addition, the latest clinical data demonstrates that the 525 mg dose is no less efficacious than 700 mg, which may potentially offer significant value to patients, payors and providers.
“We are excited to now have this new clinical data that enables us to more precisely design the protocol for our planned pivotal monotherapy trial with leronlimab (PRO140),” said Dr. Nader Pourhassan, Ph.D., CytoDyn President and CEO. “If successful, the pivotal monotherapy trial with leronlimab (PRO140) will hopefully generate the high-quality clinical data needed to underpin a successful potential label expansion, should the FDA approve our first BLA for leronlimab (PRO140) as a combination therapy,” continued Dr. Pourhassan. “We have already filed the first of three parts of the BLA for leronlimab (PRO140) as a combination therapy with HAART for HIV,” concluded Dr. Pourhassan.
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