In an interview with PharmaShots, Mari Mitrani, Chief Science Officer of Organicell shares her views on the positive results from the first ten COVID-19 patients treated with Zofin in India.
- This initial trial is being conducted in conjunction with Organicell’s Indian partner, CWI India, which has entered into a product testing and distribution agreement with Organicell to study the effects of Zofin on moderate to severe COVID-19 patients
- Based on the initial results of the trial, it will be expanded to an additional 65 patients with moderate to severe COVID-19, who will be treated at these hospitals over the next several wks., with treatments expected to be completed by the end of June 2021
- Zofin is an acellular biologic product derived from amniotic fluid and is composed of soluble proteins and exosomes
Tuba: What is Zofin? Discuss its potential in treating COVID-19?
Dr. Mitrani: Zofin is an acellular biologic product derived from amniotic fluid and is composed of soluble proteins and exosomes. The soluble protein compartment of Zofin consists of over 300 cytokines, chemokines, and growth factors. The majority of these detected cytokines are associated with host defense, anti-inflammatory, angiogenesis, and wound healing. Additionally, completed gene sequencing of Zofin revealed 102 unique miRNAs.
The microRNA within the Zofin exosome component targets important genes involved in COVID-19 infection and immune response (ACE2, IL6, TNFa) as well as those overexpressed genes that cause acute respiratory distress syndrome lung damage (VEGF, IL8). Furthermore, the systemic delivery of Zofin via intravenous infusion allows for multi-systemic targeting of immune cells and various organ compartments. It is this multi-factorial effect that triggers gene expression changes at the cellular level that leads to long-term beneficial effects in our COVID patients.
Tuba: What motivates you to conduct a clinical trial of Zofin in India?
Dr. Mitrani: India is in dire need of therapeutic treatments. Organicell is motivated to treat all humans regardless of geographic location or country. We are dedicated to creating lifesaving treatments for individuals in need throughout the world. We started working with an Indian group of physicians back in February 2021 when the pandemic was not that bad in that country but nevertheless was important to find a therapeutic for this disease.
Tuba: Why does the company believe that the Zofin will help people in combating the pandemic?
Dr. Mitrani: We are focused on the therapeutic potential of Zofin to improve the quality of life of patients around the world. Most of the industry has focused on the preventative side by creating vaccines but early on in the pandemic, we knew that therapy would be necessary. Based on our pre-clinical data, and in our single patient eIND trials, we have collected data that demonstrates Zofin reduces systemic inflammation (decreased IL6, CRP, D-Dimer), promotes lung tissue repair, and improves respiratory function.
Tuba: As the company is planning to seek EUA in India, when can we expect its availability in India?
Dr. Mitrani: Our company representatives in India are working diligently with the government and hospitals to complete the 2nd phase trial so we can expand to a EUA. For now, we do not have a timeline of when it is expected to be available, but we will follow any and all directives from Indian health officials to help expedite the process.
Tuba: Apart from India, what are other geographies in which you are seeking EUA for Zofin?
Dr. Mitrani: Currently, India, Pakistan, and United States are approved trial locations.
Tuba: What are other indications in which you are evaluating Zofin?
Dr. Mitrani: Zofin has been approved by the FDA for its use in additional clinical trials. These include knee osteoarthritis and COPD.
Tuba: 100% recovery rate in early study. What does it mean to the company?
Dr. Mitrani: We are committed to conducting all phases of the trial that are needed to ensure that this drug can be approved in the United States, India, Pakistan, and other parts of the world.
Tuba: How will Zofin is unique from its other competitors in the market?
Dr. Mitrani: With our company’s history of working with perinatal tissue, Organicell has identified and submitted patented technology for the composition of an optimal source of exosomes for regenerative therapies.
Tuba: Why do you think this therapy will be a game changer for long haulers?
Dr. Mitrani: We have identified several pathways in the inflammatory cascade that can help patients improve their quality of life, still additional research needs to be completed. To date, we have treated 4 long haulers in the past year and are awaiting FDA approval for a specific trial for this population. Our drug is administered IV and that gives us an advantaged approach as a therapeutic, due to the multi-systemic component that COVID-19 has.
Tuba: What are the company’s other efforts to help people dealing with COVID-19 and other complicated diseases?
Dr. Mitrani: Organicell is a biopharmaceutical company focused on the research and development of treatments for various degenerative and inflammatory conditions. With our treatments, we look forward to providing hope to those suffering from COVID-19, knee osteoarthritis, and COPD.
Image Source: HealthLine
About Dr. Maria Ines:
Dr. Mitrani is the Chief Science Officer and co-founder of Organicell Regenerative Medicine. Dr. Mitrani co-founded the American Cellular & Anti-Aging Center in Quito – Ecuador and was instrumental in opening additional stem cell clinics in Guatemala, Trinidad & Tobago, and Jamaica.