Organicell Regenerative Medicine (OTCBB: BPSR), a clinical-stage biopharma company developing exosome-based regenerative therapies, has announced the release of a Case Report in the peer reviewed journal Frontiers in Medicine. This case study highlights the therapeutic potential of Organicell’s proprietary therapeutic, Zofin™, and its continued success as a drug candidate.
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. This product contains over 300 growth factors, cytokines, chemokines, and 102 unique microRNAs as well as other exosomes/nanoparticles derived from perinatal tissues.
Case Report about Zofin™, an Acellular, Biologic Therapeutic
Details on the Case Report published by Frontiers in Medicine are described below.
Rationale/Objectives
A human coronavirus (HCoV-19) has caused the novel coronavirus disease (COVID-19) outbreak worldwide. There is an urgent need to develop new interventions to suppress the excessive immune response, protect alveolar function, and repair lung and systemic organ damage. Zofin (previously known as Organicell Flow) is a novel therapeutic that is derived from the soluble and nanoparticle fraction (extracellular vesicles and exosomes) of human amniotic fluid.
Here within, we present the clinical outcomes after Zofin treatment in three critically ill patients suffering from severe, multi-organ complications induced by COVID-19 infection. All patients were diagnosed with COVID-19, developed respiratory failure, and were hospitalized for more than 40 days.
Methods
Zofin was administered to patients concurrently with ongoing medical care who were monitored for 28-days post-therapy. SOFA score assessment, chest X-rays, and inflammatory biomarker testing was performed.
Main Results
There were no adverse events associated with the therapy. The patients showed improvements in ICU clinical status and experienced respiratory improvements. Acute delirium experienced by patients completely resolved and inflammatory biomarkers improved.
Conclusions
Primary outcomes demonstrate the therapy was safe, accessible, and feasible. This is the first demonstration of human amniotic fluid-derived nanoparticles as a safe and potentially efficacious therapeutic treatment for respiratory failure induced by COVID-19 infection.
Discussion
These completed case studies are the first demonstrations of human amniotic fluid-derived nanoparticles as a safe and potentially efficacious therapeutic treatment to recover from complications induced by COVID-19 infection. The multi-dose administration of Zofin as a therapeutic approach for patients severely ill from COVID-19 was safe and well-tolerated, without the report of any serious adverse events.
The molecular composition of Zofin, particularly the nanoparticle population that includes perinatal secreted extracellular vesicles and exosomes, has strong potential as a COVID-19 therapeutic. Extracellular and exosome-based therapeutics are beginning to be explored in the clinic and have quickly emerged as a promising therapeutic candidate due to the anti-inflammatory and tissue regenerative effects shown across various pre-clinical models.