new ymb post by rantes RANTES1 hour ago Biomm
Post# of 148277
RANTES1 hour ago
Biomm just released it's 4th Qtr results and will hold a webcast on Monday at 3pm Brazil time ( 11am PST). There was zero negative news on the ongoing trials which pretty much just says what one would expect if everything was on track. Perhaps we will get a mention on trial participant numbers then? Probably not...
CytoDyn Inc. (United States): on April 6, 2021, the Company celebrated an exclusive agreement with the company CytoDyn Inc. (“CytoDyn”), for the
potential supply of the drug Leronlimab in Brazil.
Considering the potential use of Leronlimab in the treatment of patients diagnosed with Covid-19, who are hospitalized and requiring oxygenation, its emergency use was requested by the CytoDyn with the FDA - Food and Drug Administration in the United States, Health Canada and MHRA - Medicines and Healthcare Products Regulatory Agency in the UK. On August 2, 2021, ANVISA approved the dossier of Experimental Clinical Drug Development (DDCM) of the monoclonal antibody Leronlimab in Brazil, Resolution RE nº 3001, of 30 of July 2021, DOU 08/02/2021. The study is being conducted by
Academic Research Organization (ARO) of Hospital Israelita Albert Einstein(HIAE), in collaboration with CytoDyn, a North American company responsible for drug development. Biomm S.A is
sponsor of the study with ANVISA and exclusive partner for the marketing of Leronlimab in Brazil.
Two clinical studies are being carried out using the antibody monoclonal Leronlimab, being: (i) the first one, intended for the treatment of critically ill patients. The protocol that includes hospitalized patients who are in a serious condition of Covid-19 covers those in need of mechanical and invasive ventilation or in use of Extracorporeal Membrane Oxygenation (ECMO); and, (ii) the second, intended for patients in moderate states with Covid-19. The protocol that covers moderate patients with Covid-19 covers those with need for oxygenation support, but no need for invasive mechanical ventilation. Clinical studies will be conducted individually, each with its own specific protocol, using several research centers distributed in throughout the national territory, which are involved in this project.