CytoDyn Inc. announces that it has submitted to the U.S. Food And Drug Administration (FDA) an application for orphan drug designation for the use of PRO 140 (humanized monoclonal antibody to CCR5) in the pretreatment of HIV Type-1 (HIV-1) infection in treatment-naïve adults while they are waiting for drug resistance assay results to construct a subsequent Highly Active Antiretroviral Therapy (HAART) regimen. The generation of these assay results typically takes approximately two weeks.
On July 18, CytoDyn submitted a protocol to the FDA for a Phase 2b clinical trial with PRO 140 for treatment-naïve HIV adults and the Company expects to file for a breakthrough therapy designation upon receipt of successful results for the first few patients. The Company believes that should the treatment-naïve trial be successful, it may position PRO 140 for a much faster path to approval compared with the Company’s two other Phase 3 trials with PRO 140.
CytoDyn President and CEO, Nader Pourhassan, Ph.D., commented: “We believe the construct of the treatment-naïve population trial demonstrates how different PRO 140 is compared with all other approved HIV drugs. PRO 140 is in a unique new class because it is the first self-administered, subcutaneous injectable antibody that could decrease the viral load of an HIV patient by as much as 1.65 log 10 by way of weekly injections in just three weeks.”
Dr. Pourhassan added: “We are pleased with our ability to continue to identify additional new and innovative opportunities to advance PRO 140 along multiple concurrent paths toward approval. We believe this treatment-naïve path offers many advantages to CytoDyn to potentially receive its first approval from the FDA for use of PRO 140. CytoDyn has now positioned PRO 140 in two Phase 3 trials for chronic conditions in two different HIV patient populations and one clinical trial in acute condition for HIV.”
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