Zofin™ is an acellular, non-HCT/P biologic, currently being studied in clinical trials under approved IND applications. Zofin™ is derived from perinatal sources and is manufactured to retain the naturally occurring nanoparticles and microRNAs, without the addition or combination of any other substance or diluent. Zofin™ is currently undergoing Phase I/II FDA approved clinical trials for COVID-19, COPD, and Osteoarthritis.
Organicell is actively investigating the therapeutic safety and efficacy of Zofin™ in subjects with various stages of COVID-19 infection: mild to moderate, moderate to severe, and Post COVID-19 Complications. Through the FDA’s single patient emergency/compassionate use mechanism, Organicell has treated 18 subjects to observe Zofin™ safety, while secondarily observing clinical improvements. These patients were intravenously administered with Zofin™ and followed for 28 days post therapy. Furthermore, under expanded access, Zofin™ has been administered to patients with mild to moderate COVID-19 infection.
These studies demonstrate the first use of a human perinatal-derived nanoparticle biologic as a safe and potentially efficacious therapeutic treatment for acute respiratory distress syndrome induced by COVID-19 infection.
| 1 | 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
https://clinicaltrials.gov/ct2/show/NCT04384445?term=organicell&draw=2&rank=1 |
| 2 | Expanded Access to Zofin™ for the Treatment of Patients With Mild to Moderate COVID-19 Due to SARS-Cov-2 for Outpatient and Inpatient Population
https://clinicaltrials.gov/ct2/show/NCT04657406?term=organicell&draw=2&rank=4 |
| 3 | 18 Single Patient Emergency / Compassionate Use Cases with COVID-19: Published results of the first 3 subjects are available here:
https://www.frontiersin.org/articles/10.3389/fmed.2021.583842/full |
| 4 | A Phase I/II Multicenter, Randomized, Double-Blinded, Placebo Trial to Evaluate the Safety and Potential Efficacy of Zofin™ Infused Intravenous (IV) in Patients Experiencing Prolonged COVID-19 Symptoms (Long-Haulers) vs Placebo. |
| 5 | 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 COPD vs Placebo |
| 6 | 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 Knee Osteoarthritis vs Placebo |
Additional trials are being completed with Zofin™ for COVID-19 patients in India and Pakistan. In India, the treatment of 10 hospitalized patients was completed in collaboration with Organicell’s Indian partner, CWI India. Based on the initial results of this trial, the patient population was expanded to include an additional sixty-five patients with moderate to severe COVID-19. Likewise, the Drug Regulatory Authority of Pakistan has approved Zofin™ for compassionate use. In response to this approval, Organicell has received further authorization to begin a broader trial of Zofin™ with up to 60 additional patients suffering from moderate to severe COVID.
The core of our comprehensive translational plan is to develop our intervention as an available treatment option for society during the COVID-19 pandemic and any future pandemic. This plan includes the completion of necessary pre-clinical and clinical trial testing of our novel biologic in order for advancement to market. Conducting well designed clinical trials is often the most expensive and rate-limiting part of a translational program, however, is necessary for the regulatory approval and market success of therapeutic biologics. By following a carefully planned set of clinical trials, we plan to progress from our proposed Phase I/II “safety” and “proof of concept” trials to large Phase III trials where a greater number of patients may benefit from the results of these trials, and eventual FDA approval may be obtained.
Our immediate next phase is to expedite the approval of Phase IIB and Phase III trials (estimated 12 months for completion) and post marketing phase (estimated 8 to 12 months for completion). Depending on trial outcomes, we will pursue FDA’s accelerated pathway to obtain a 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.
In the event of product approval, our team will develop a comprehensive plan to evaluate all aspects of the market. This plan will include a strategy to train a diverse array of stakeholders who will serve as product ambassadors, the training of medical professionals for product use and documentation, and the generation of other printed and online material for patients and general public.
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