Largest society in the Industry "Regulatory Affair
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Posted On: 05/25/2020 5:39:05 AM
Largest society in the Industry "Regulatory Affairs Professional Society" (RAPS) newly listed Leronlimab as therapeutic for Covid-19:
COVID-19 therapeutics tracker
Posted 22 May 2020 | By Jeff Craven
Updated 23 May to include new information on hydroxychloroquine, convalescent plasma, favilavir, EIDD-2081, leronlimab and sarilumab.
Drug: Leronlimab
Medication class: Humanized IgG4 monoclonal antibody
Developer: CytoDyn (as PRO 140)
Original proposed indication: Leronlimab has received FDA fast track designation for use with carboplatin to treat CCR5-positive metastatic triple-negative breast cancer and in combination with highly active antiretroviral therapy (HAART) in HIV.
Rationale: Leronlimab is a CCR5 antagonist that blocks the CCR5 co-receptor on the surface of immune cells like CD4 cells. It is believed that leronlimab can enhance the immune response in patients experiencing CRS from respiratory distress caused by COVID-19.
Trials: CytoDyn is planning two clinical trials evaluating leronlimab in patients with mild to moderate and severe cases of COVID-19. In the trial of severe COVID-19 cases, announced on 1 April, CytoDyn aims to enroll 342 patients and administer leronlimab or placebo for 2 weeks with a primary endpoint of 14-day mortality. Another trial in collaboration with the Mexican National Institutes of Health is also planned.
Outcome: FDA authorized use of leronlimab in COVID-19 patients under an eIND. Patients treated under the eIND have a lower level of cytokine storm and lower levels of IL-6 and TNF-alpha. A pre-print of results from the trial evaluating severely or critically ill COVID-19 patients showed leronlimab was effective at reducing IL-6 expression and in reversing immunosuppression, which led to a lower plasma viral load.
Status: A Phase 2b trial has enrolled 15 patients with mild-to-moderate COVID-19 and one patient with severe disease has been treated in a Phase 2b/3 trial, CytoDyn announced 15 April. On 30 April, CytoDyn’s CEO noted that 49 patients treated with leronlimab under eIND were responding “extremely well” and expects publication of their first results shortly.
https://www.raps.org/news-and-articles/news-a...cs-tracker
COVID-19 therapeutics tracker
Posted 22 May 2020 | By Jeff Craven
Updated 23 May to include new information on hydroxychloroquine, convalescent plasma, favilavir, EIDD-2081, leronlimab and sarilumab.
Drug: Leronlimab
Medication class: Humanized IgG4 monoclonal antibody
Developer: CytoDyn (as PRO 140)
Original proposed indication: Leronlimab has received FDA fast track designation for use with carboplatin to treat CCR5-positive metastatic triple-negative breast cancer and in combination with highly active antiretroviral therapy (HAART) in HIV.
Rationale: Leronlimab is a CCR5 antagonist that blocks the CCR5 co-receptor on the surface of immune cells like CD4 cells. It is believed that leronlimab can enhance the immune response in patients experiencing CRS from respiratory distress caused by COVID-19.
Trials: CytoDyn is planning two clinical trials evaluating leronlimab in patients with mild to moderate and severe cases of COVID-19. In the trial of severe COVID-19 cases, announced on 1 April, CytoDyn aims to enroll 342 patients and administer leronlimab or placebo for 2 weeks with a primary endpoint of 14-day mortality. Another trial in collaboration with the Mexican National Institutes of Health is also planned.
Outcome: FDA authorized use of leronlimab in COVID-19 patients under an eIND. Patients treated under the eIND have a lower level of cytokine storm and lower levels of IL-6 and TNF-alpha. A pre-print of results from the trial evaluating severely or critically ill COVID-19 patients showed leronlimab was effective at reducing IL-6 expression and in reversing immunosuppression, which led to a lower plasma viral load.
Status: A Phase 2b trial has enrolled 15 patients with mild-to-moderate COVID-19 and one patient with severe disease has been treated in a Phase 2b/3 trial, CytoDyn announced 15 April. On 30 April, CytoDyn’s CEO noted that 49 patients treated with leronlimab under eIND were responding “extremely well” and expects publication of their first results shortly.
https://www.raps.org/news-and-articles/news-a...cs-tracker
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