The FDA grants Zofin for the treatment of COVID-19 to Organicell Regenerative Medicine (OTCPK:BPSR -3.3%).
Zofin is an acellular biologic therapeutic derived from perinatal sources and is manufactured to retain naturally occurring microRNAs, without the addition or combination of any other substance or diluent.
Alongside Convalescent Plasma, Zofin is the first reported acellular therapy under FDA’s approved expanded access program.
A 6 subject will be treated under emergency IND to evaluate significant improvement after being treated with Zofin.
The company will commence Phase I/II placebo controlled clinical trial and is in the process of recruiting moderate to severe COVID-19 patients to evaluate the safety and potential efficacy of Zofin.