How long ago was it that Nader said that we'd get HIV FDA approval "for sure" within a couple of weeks....?? Phase 3 Trial met it' Primary Endpoint and BLA was being submitted???
CytoDyn Announces Publication of Peer-Reviewed Paper, “Suppression of Human and Simian Immunodeficiency Virus Replication with the CCR5-Specific Antibody Leronlimab in Two Species”
BY GlobeNewswire
— 8:30 AM ET 04/12/2022
VANCOUVER, Washington, April 12, 2022 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced the publication of a peer-reviewed research paper entitled “Suppression of human and simian immunodeficiency virus replication with the CCR5-specific antibody Leronlimab in two species” in the open-access journal PLOS Pathogens.
The study followed five HIV+ human participants who, after successfully transitioning to once weekly subcutaneous leronlimab, halted their previous daily oral antiretroviral therapy regimens. These five participants came from an extension study, consisting of patients who were virologically suppressed in a prior study of leronlimab. Of the ten patients enrolled in the extension study, four individuals experienced viral rebound and stopped leronlimab monotherapy, and one individual withdrew, leaving five long-term participants. All five long-term participants successfully maintained HIV suppression via leronlimab monotherapy for over seven years, with no evidence of viral escape. It is important to note that these five participants on leronlimab monotherapy exhibited a higher frequency (7.1%) of transient episodes of plasma viremia, termed viral blips, than those on combinational oral antiretroviral regimens (2.0%). To monitor the anatomical penetrance of leronlimab, rhesus macaques acutely infected with simian human immunodeficiency virus (SHIV) were treated with high intravenous doses of leronlimab for 12 weeks. Leronlimab treatment reduced SHIV viral loads by 10,000 fold and leronlimab was found within all anatomical compartments analyzed, including mucosal and lymphatic tissues, sites of early viral replication after transmission and latency, respectively.
Jonah Sacha, Ph.D., the lead study author, who is a CytoDyn (CYDY) scientific advisor and an Oregon Health & Science University professor, stated, “To our knowledge, these data represent the longest administration of monoclonal antibody monotherapy for HIV in people to date.”
CytoDyn Announces Publication of Peer-Reviewed Paper, “Suppression of Human and Simian Immunodeficiency Virus Replication with the CCR5-Specific Antibody Leronlimab in Two Species”
BY GlobeNewswire
— 8:30 AM ET 04/12/2022
VANCOUVER, Washington, April 12, 2022 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced the publication of a peer-reviewed research paper entitled “Suppression of human and simian immunodeficiency virus replication with the CCR5-specific antibody Leronlimab in two species” in the open-access journal PLOS Pathogens.
The study followed five HIV+ human participants who, after successfully transitioning to once weekly subcutaneous leronlimab, halted their previous daily oral antiretroviral therapy regimens. These five participants came from an extension study, consisting of patients who were virologically suppressed in a prior study of leronlimab. Of the ten patients enrolled in the extension study, four individuals experienced viral rebound and stopped leronlimab monotherapy, and one individual withdrew, leaving five long-term participants. All five long-term participants successfully maintained HIV suppression via leronlimab monotherapy for over seven years, with no evidence of viral escape. It is important to note that these five participants on leronlimab monotherapy exhibited a higher frequency (7.1%) of transient episodes of plasma viremia, termed viral blips, than those on combinational oral antiretroviral regimens (2.0%). To monitor the anatomical penetrance of leronlimab, rhesus macaques acutely infected with simian human immunodeficiency virus (SHIV) were treated with high intravenous doses of leronlimab for 12 weeks. Leronlimab treatment reduced SHIV viral loads by 10,000 fold and leronlimab was found within all anatomical compartments analyzed, including mucosal and lymphatic tissues, sites of early viral replication after transmission and latency, respectively.
Jonah Sacha, Ph.D., the lead study author, who is a CytoDyn (CYDY) scientific advisor and an Oregon Health & Science University professor, stated, “To our knowledge, these data represent the longest administration of monoclonal antibody monotherapy for HIV in people to date.”
4
