Zofin is a nanoparticle based therapeutic showing tremendous promise in the battle against COVID-19. Zofin is derived from perinatal sources and is manufactured to retain the naturally occurring microRNAs, without the addition or combination of any other substance or diluent.
ORGANICELL’S EXPERIENCE WITH COVID-19
Organicell has treated 3 subjects suffering from severe COVID-19 Acute Respiratory Distress Syndrome using Zofin. Three separate “emergency expanded access single patient” INDs have been requested from the FDA. The primary objective of these three eINDs was to demonstrate the safety of Zofin™ in these severely ill patients, while secondarily observing clinical improvement. Our results demonstrate the first use of an amniotic fluid derived product in human as a potentially therapeutic to aid in the recovery from COVID-19 infection. Patients were intravenously administered with Zofin™ and followed for 21 days post therapy. The patients improved their ICU clinical status and experienced respiratory improvements. 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.
ORGANICELL’S COVID TRIALS
- eIND#22897 approved on 05/29/2020 – Acute respiratory failure with hypoxia, secondary to COVID-19 with ARDS – IRB # 1-1311322-1 application was submitted and approved.
- eIND#22370 approved on 05/11/2020 – Treatment for Acute hypoxic respiratory failure with ARDS secondary to COVID-19 infection – IRB#1-1308238-1 application was submitted and approved.
- eIND#22370 approved on 05/11/2020 – Treatment for Acute hypoxic respiratory failure with ARDS secondary to COVID-19 infection – IRB#1-1308238-1 application was submitted and approved.
- IND # 19881 approved on 04/30/2020 – A Phase I/II Randomized, Double Blinded, Placebo Trial to Evaluate the Safety and Potential Efficacy of Intravenous Infusion of Zofin™ for the Treatment of Moderate to Severe Acute Respiratory Syndrome (SARS) Related to COVID-19 Infection vs Placebo.
TRANSLATIONAL PLAN
The central part of our comprehensive development plan is to transition our intervention to make it available to the society during this COVID-19 pandemic through carefully planned set of clinical trials, progressing from the proposed Phase II “proof of concept”, and then to the later trials where more patients can benefit from the result of this trial. Clinical trials are often the most expensive and rate-limiting part of a program, so considerable effort goes into designing trials that are both necessary and sufficient for regulatory approval and market success. The proposed trials will also provide the data for phase III clinical trial.
The next phase is to expedite phase IIB and phase III trials (estimated 12 months for completion) and post marketing phase (estimated 8 to 12 months for completion). Organicell Regenerative Medicine University Miami – Life Science & Technology Park 1951 NW 7th Ave – Suite #300, Miami, FL 33136 info@organicell.com www.organicell.com Phone: (888) 963-7881 Fax: 1-786 472 7020 Depending on trial results, if strong efficacy is confirmed, we will pursue FDA’s accelerated pathway to obtain Biological License (BLA) for the use of Zofin™ for COVID-19 patients. These pathways are: 1) Breakthrough 2) Therapy Accelerated Approval 3) Fast Track and 4) Regenerative Medicine Advanced Therapy Designation.
Our team will develop a comprehensive plan to evaluate all aspects of marketing the product and training the diverse array of stakeholders who will be the ambassadors for the new product. The plan will include a strategy to address the specific needs of a marketing plan, training of medical professionals, documentation, and other pertinent printed and online material for patients and general audiences.
PREVENTIVE POTENTIAL OF ZOFIN™
We have completed extensive molecular characterization of the natural biological properties of Zofin and have identified exosomes carrying several miRNA involved in the promotion of immune regulation and response. Similarly, we have identified miRNA that target ACE2, the key protein involved in COVID-19 infection, and hypothesize that the presence of these miRNA may boost immune system response and prevent COVID-19 infection severity.