Clinical-stage biopharma firm Organicell Regenerative Medicine has announced positive results for a trial centered in India involving the first 10 COVID-19 patients treated with Zofin. The initial trial, conducted in conjunction with Organicell’s Indian partner CWI India, aimed to study the effects of the treatment on COVID-19 patients with moderate to severe cases.
The 10 initial trial participants were patients admitted and treated at three different facilities:
- Narayana Hrudayalaya Hospital, Bangalore
- Lisa Hospital in Kozhikode, Kerala
- Prime Indian Hospital, Chennai
According to researchers, all 10 patients have recovered from their symptoms, and all have been discharged. Organicell reports that based on the initial trial results, it will be expanded to another 65 patients with moderate to severe COVID-19, treated at the three hospitals over the next several weeks, with treatments expected to be completed by the end of June 2021.
If the results of the expanded trial are similarly positive, Organicell and CWI India reportedly intend to file with the ICMR (Indian Council for Medical Research) for emergency-use approval to use Zofin in India as a therapeutic for treating COVID-19.
The COVID-19 situation in India is among the direst across the globe. CNN reported that according to the Indian Health Ministry’s tally, on Thursday, May 6 the country incurred 412,262 new cases and 3,980 deaths—a new single-day record.
“The explosive spread of COVID-19 in India, and the lack of treatment that is available to help these millions of people, is quite alarming and tragic,” said Organicell CEO Albert Mitrani. “We are hopeful that Zofin can continue to help these patients, and we will do everything we can to expedite this process.”
Matthew Roshan of CWI India said, “We are very encouraged with the results shown by patients using Zofin and are hopeful that the remaining trial patients will show similar results. These trials could set the stage for a very quick Emergency Use Approval to be able to use Zofin for all of our patients.”
Zofin is an acellular biologic therapeutic culled from perinatal sources, manufactured to retain naturally occurring microRNAs without the addition or combination of any other substance or diluent. According to Organicell, the treatment contains more than 300 growth factors, cytokines, and chemokines, in addition to other extracellular vesicles/nanoparticles derived from perinatal tissues.