Back in May, TrialSite reported that Landmark Hospital, a group of long-term acute care hospitals across the southeastern United States, announced its decision to study an investigational allogenic biologic product to test on patients with advanced COVID-19 conditions under the U.S. Food and Drug Administration (FDA) approved Compassionate Use pathway. TrialSite reported that the first patients were treated with the investigational regimen known as Zofin (Organicell Flow). Reports at the time were that the intravenous infusions of the biologic investigational regimen were administered safely to two patients and that they were clinically stable. A few months later, TrialSite was able to conduct a brief interview with the South Florida-based company for a brief TrialSite breakdown. It turns out the study results have gone well.
What is Organicell’s mission and what differentiates your company from other companies in the regenerative science space?
Organicell is a clinical-stage biopharmaceutical company that harnesses the power of exosomes to develop innovative biological therapeutics for the treatment of degenerative and inflammatory diseases. Based in South Florida, the company was founded in 2008 by Albert Mitrani, Chief Executive Officer and Dr. Mari Mitrani, Chief Scientific Officer.
There are many biotech companies that are focused on individual aspects of regenerative medicine development, but our company is doing so many things on different levels – we are covering all aspects of regenerative medicine research. Not only do we have to demonstrate the proof of concept and drug mechanisms through in vitro cell culture assays and in vivo small-animal models, but most importantly through the collection of safety and efficacy data in humans and importantly through our own manufacturing of cGMP quality biologics. We have forged many relationships with collaborators in academia, hospitals and throughout various tech industries.
Differences between stem cell and exosome based therapies, and how do they compare?
One of the most exciting discoveries of recent times is the regenerative capacity of stem cells and other cell-based therapies. The delivery of these cell products has been shown in animal models as well as phase II clinical trials, to provide tissue modulatory effects that promote regeneration and healing. However, research has uncovered that stem cell beneficial effects are mainly paracrine-mediated via the release of extracellular vesicles called exosomes. Exosomes are small, nano-sized vesicles released from all cell types that transmit various proteins, microRNAs, and other signaling molecules directly to the injury site. Therefore, over the past few years, regenerative medicine has expanded from live cells to acellular exosomes. Organicell has positioned itself in the forefront of exosome research through the development of novel manufacturing techniques to isolate and concentrate exosomes for therapeutic and clinical use.
How did Organicell respond to the COVID-19 pandemic?
Organicell has been working to demonstrate the therapeutic potential of our lead product Zofin (Previously called Organicell Flow) for chronic lung disorders, such as bronchopulmonary dysplasia (BPD), COPD and pulmonary hypertension.
When the COVID-19 pandemic hit, Organicell immediately shifted its focus towards the development of a potential clinical strategy to treat COVID-19 infection and the secondary lung and multi-organ injuries it creates. From our preclinical experience in animals and our collection of in-vitro characterization data, we hypothesized that our drug would be a prime candidate for COVID-19 treatment due to the protein and exosome-rich composition.
The accumulation of our preclinical evidence led to our submission of an IND application to the FDA to complete a placebo-controlled, double-blinded clinical trial testing of Zofin in patients with Severe Acute Respiratory Distress Syndrome induced by COVID-19. After receiving FDA approval for this application, we immediately filed for the emergency and compassionate use IND application to administer our drug to three patients in critical care with the COVID-19 infection in the ICU. All patients have seen remarkable improvement in their clinical status; lung, brain and renal function confirmed by follow up chest X-Rays and lab data. Other organs such as the heart and liver commonly affected in patients who have been infected by SARS-CoV-2 virus, have all shown progressive improvement in their function.
Furthermore, Organicell received two eIND FDA approvals for the first outpatients to be treated with any drug for COVID-19. The first patient has shown a remission of cough and shortness of breath and fatigue. The second outpatient previously spent seven weeks in the hospital, was admitted to the ICU twice, received Bi-Level Positive Airway Pressure (BiPAP) treatment and continued to experience shortness of breath after hospital discharge. Now, being treated as an outpatient, he has reported improvements in all his symptoms and is considering going back to work.
So Exosome therapies may be beneficial to treat COVID-19?
Exosomes contain a rich collection of protein and miRNA cargo that have a therapeutic potential to act as a suppressor of cytokine activation and promote immune response. The miRNA composition of exosomes is a critical component to the therapeutic effect, as miRNA are small nucleic acid molecules that can down regulate or inhibit genes contributing to the disease. Exosomes are thought of as cell re-programmers and have the ability to turn on or turn off various signaling pathways from within the cell. Evidence is accumulating that suggests these exosome-mediated messages may be protective to the immune system as well as excessively inflamed organs.
What are Zofin’s differences from other exosome-based therapies?
Zofin is an exosome-rich investigational product, which contains a source of exosomes that does not require lengthy in-vitro cell culture manipulation. We have developed an acellular product that is designed to preserve the natural composition of growth factors and exosomes. We’ve developed the technology to isolate these supportive factors and concentrate them in a novel therapeutic.
What are Organicell’s near-term goals and objectives?
We are continuing to expand our clinical trial portfolio to investigate Zofin under FDA approved clinical trials. We are actively working with our collaborators to develop novel treatment protocols for COPD, Bronchopulmonary Dysplasia (BPD), and other inflammatory conditions, such as Osteoarthritis.
Our goal is to obtain regulatory approval for the use of our products that we intend to sell and distribute throughout the United States and worldwide.
Are you looking for partnerships?
Potentially as well as possible financing to help fund and expedite our research and development efforts, including capital intensive clinical trials, as well as identifying strategic partnerships that allow us to acquire additional IP and expertise that can be leveraged with our existing research and development efforts as well as national distribution platform capable of successfully launching commercialization of our FDA approved products.