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Organicell Regenerative Medicine, Inc. (OTCMKTS:BPSR) 

ALBERT MITRANI has been Chief Operating Officer, President and board member at Organicell Regenerative Medicine, Inc. since April 2018, and he also is the Chairman of the board, Chief Executive Officer, Secretary and Treasurer at Organicell Regenerative Medicine, Inc. — alternate name Biotech Products since June 24, 2011. Mr. Mitrani formerly was the Chief Executive Officer, President and Director of Analytical Stem Cell Corp. from April 2014 to May 2015. From February 2012 to March 2014, he was the Chief Executive Officer of Americell Trinidad and the President of ASCAAC LLC — American Stem Cell — from March 2011 to January 2013. Mr. Mitrani was the Chief Executive Officer of American Cellular Center in Quito Ecuador from 2009 through 2012. 

SECTOR — PHARMACEUTICALS 

(BCQ602) TWST: Could you tell me about the company? 

Mr. Mitrani: Organicell is a clinical-stage biopharmaceutical company. We founded the company in 2008 and took it public in 2012. 

TWST: Have there been any noteworthy events recently for the company? 

Mr. Mitrani: Yes, very significant developments for Organicell around the COVID-19 infection. For several years, we have been doing a lot of research in various areas, specifically around lung diseases, and have collected data, more specifically around lung reparation. When COVID hit, we came to the realization that through all of our work and expertise around regenerative therapeutics for the lungs, that there could be a potential opportunity for us to make a big difference in the treatment of this virus, particularly for patients with more severe lung injury and illness. We developed what we believe to be a potential therapeutic for COVID-19 and are currently investigating our lead therapeutic for safety and efficacy in clinical trials. This therapeutic is called Zofin. 

TWST: Is it being tested now? 

Mr. Mitrani: It is. First, I will provide some history around how we arrived to where we are today. It was 15 years of research and data that has brought us to this position. 

My wife, Dr. Mari Mitrani, and I started this company about 15 years ago when we began studying autologous stem cells — autologous meaning stem cells from the patient. And we got into it literally by accident. 

In the old days, there was a big term “anti-aging,” and we were in the anti-aging business. A group of hematologists said to us, “If you want to be in real anti-aging, you’ve got to look into stem cells.” We looked at each other and asked, “What are stem cells?” 

Next thing we know, we’re living in Quito, Ecuador, my wife’s hometown, where we started a very small research and treatment center. And within a year, our 1,200-square-foot center grew to about 30,000 square feet, and we were treating patients from all over the world using this newly founded stem cell technology. 

We came back to the U.S. about 12 years ago. And with this knowledge of stem cells, we transitioned out of autologous stem cells and began searching for a regenerative therapy that would be more consistent. Particularly, something that we would be able to commercialize with reproducible and consistent effects. 

Autologous stem cell therapies utilized autologous stem cells derived from the patient’s own blood. When you isolate these cells, the stem cell quality varies from patient to patient. The health of the stem cell population is largely dependent upon the patient’s health status and underlying conditions. 

In our search for a better therapeutic source of cells for regenerative therapies, we ultimately focused on perinatal tissue. We then spent a few years focusing on the therapeutic potential of perinatal tissue and researching the various components, such as Wharton’s jelly umbilical cord cells, amniotic membrane and amniotic fluid. About four years ago, this research led us more deeply into the paracrine factors that are released by the perinatal tissue. These paracrine factors include molecules such as growth factors, cytokines, extracellular matrix proteins, and various chemicals and minerals. 

However, one component of paracrine factors that we found to be most promising for regenerative therapies were cell-secreted nanoparticles called “exosomes” and extracellular vesicles. This type of therapy no longer requires the use of stem cells or cells. Our ability to identify and isolate these perinatal-derived exosomes is what really changed the direction of our company. We knew it was something that had tremendous therapeutic potential and that the FDA would support with the collection of our preclinical data. 

In the last couple of years, we started collecting a lot of data. We started filing what’s called INDs — investigational new drug applications — with the FDA to do trials for COPD and osteoarthritis. 

In November 2019, before the virus hit, we started doing various preclinical studies, in animal models, to establish the therapeutic potential of our lead products for the treatment of lung diseases. And we discovered that the exosome component of our therapy leads to significant improvement in lung structure. We’re continuing those studies right now. 

So upon the onset of COVID in the U.S., we had hundreds of pages of preclinical and translational data that we compiled into 

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an IND for submission to the FDA as a request to begin clinical trials for COVID-19. Something to keep in mind is that our company is very small relative to the big players, including Merck or Pfizer, for example. The FDA within about 30 to 40 days, provides their approval for our company to complete the first randomized, double-blinded study — clinical trial — for a product such as ours to treat lung impacts from COVID-19. That trial is continuing today. 

In addition to that, we applied for single-patient emergency/compassionate use INDs, which are approved for a single patient by request of the treating physician to aid in a patient’s recovery from the COVID-19 infection. 

For Organicell, this experience has been one of the most exciting and important things that we have completed in our clinical development. To start, we treated three severely ill patients with COVID-19 at Landmark Hospital’s ICU. These patients had exhausted all other medical options and were offered the right to try our therapeutic. Over a short period of time, these patients all significantly improved and were discharged from the hospital. Most of their complications resulting from the virus were resolved. 

We subsequently asked the FDA if we could treat some outpatients to try to help lessen the health care worker burden in the hospitals. We treated several COVID outpatients with our therapeutic, and their conditions resolved usually within less than eight days. 

Then, there was one other group of patients called “long-haulers.” The long-haulers are a population of patients that cleared the virus infection but, after months, are still experiencing debilitating post-COVID-19 complications, such as shortness of breath, fatigue, palpitations and mental fog. We treated these long-haulers, all of whom have improved their symptoms and are going back to their daily lives. 

Ideally, the aim is to develop a therapeutic that works for all classifications of these COVID patients, from initial onset in the early stages to the prevention of further escalation to intubation or an ICU stage. We are currently in the beginning stages of our placebo-controlled clinical trials, which we think will be an exciting development. 

TWST: Maybe you could explain the therapeutic. 

Mr. Mitrani: The needle in the haystack is that our product is derived from perinatal tissue. The biologic product is natural, with no addition of non-natural additives or diluents. Importantly, the product is not derived from cultured stem cells or contains cells. We have a patented process for the processing, composition and clinical usage of this product. 

Organicell has developed a processing technology to extract the free-flowing nanoparticles from perinatal fluid. By doing that, we obtain perinatal-derived exosomes. Exosomes are cell-derived messengers. If the body had its own internet, these exosomes would be considered the messengers that are sent from cell to cell to deliver various signaling messages. Exosomes deliver these messages by transferring the intra-exosome cargo to recipient cells. This cargo includes various molecules such as proteins, enzymes and RNA. 

But even more important than that, and this is the big story, is that our company identified over 100 microRNA — miRNA — carried within these exosomes. In simple terms, the miRNA that we found, specifically for COVID-19, are what we believe to be the therapeutic key. In a proverbial sense, the key is the miRNA, and the lock is COVID. 

We have plenty of pages of data to support the therapeutic potential of these miRNA to treat COVID-19. So not only are we able to show the patient’s response, we are compiling data on our therapeutic mechanism of action. And the nice thing that we have is, unlike big companies, we’re not looking for the vaccine. They’re all on the vaccine trail, and we’ve been on the therapeutics side. 

TWST: What’s the next step in the process for the therapeutic development? 

Mr. Mitrani: Right now, we’re in Phase I/II clinical trials for moderate to severe COVID-19 patients. We’re continuing to file for eINDs. After the completion of these initial trials, our plan is to move into larger Phase III trials. 

Phase III will put us on the pathway for a drug that will involve probably a few thousand to 30,000 patients. But we have been speaking now directly with various agencies within the NIH — the National Institutes of Health — and we’re hoping we can get put on Operation Warp Speed. Warp Speed would give us a rapid way to get through Phase III. All of our preparation is in order now to move as rapidly as we can to push forward toward a BLA license, which is FDA approval for a new drug. 

TWST: Once you get that license, then could it be sold commercially? 

Mr. Mitrani: Correct. Many things can happen between now and the next few weeks. So we have started on our own by scaling up our manufacturing. What we do, which is very different than anybody else, as I mentioned, our product is really hands-on. It’s not a chemically synthesized pill or pharmaceutical. As a biologic, it takes us much longer to scale up. But for now, we have kept product manufacturing internal and are working to meet our clinical trial needs. 

TWST: From what I understand, there could be several therapeutics from different manufacturers to treat the same ailment or illness; it just depends on what situation that person is in, what they’ll need. Can you have more than one in the mix? 

Mr. Mitrani: Well, right now, we have a one-size-fits-all therapeutic that has treated all types of COVID-19 conditions, whether patients are in an ICU to somebody who just got diagnosed with COVID-19. We have an approved dosage protocol right now. 

Another thing to note is that our product is administered intravenously. Therefore, we had to go through a lot of testing to prove safety, which we have accomplished with our completed eIND trials. However, we are considering different delivery systems, 

“We have plenty of pages of data to support the therapeutic potential of these miRNA to treat COVID-19. So not only are we able to show the patient’s response, we are compiling data on our therapeutic mechanism of action.”

possibly for the long-haulers through intramuscular injection. 

What makes us unique is that we have a natural-occurring product that we can use across all different populations. As I mentioned, we believe the miRNAs in our product are the critical component of our therapeutics’ efficacy. The diversity of these miRNAs may be the key to treatment of the many different conditions in COVID-19 and potentially other inflammatory illnesses. 

TWST: Where does it stand now as far as these other conditions like COPD, muscular issues and osteoarthritis? Are they still in the testing phases? 

Mr. Mitrani: Yes. In osteoarthritis, we have an approved IRB — institutional review board — with the Hospital for Special Surgery. Unfortunately, a lot of clinics stopped trials because of COVID, but now that things are starting to open up, these hospitals are gearing up for different types of trials like osteoarthritis and COPD. 

We are now going to be filing again and getting ready to begin trials. I’m hoping within the next 60 days, if not sooner. Then, we’ll have multiple ongoing trials. These trials will keep our plates quite full because COVID-19 is taking up a tremendous amount of our bandwidth. 

On top of everything else, we came up with another product, which is a derivative of our currently tested therapeutic. Our current therapeutic, Zofin, has growth factors, cytokines and other soluble molecules aside from the exosomes and nanoparticles. The next product that we’re developing is a pure, cleaned exosome product. 

TWST: You mentioned your interactions with the regulatory community and government agencies. There’s a U.S. presidential election coming up in November. Do you think that your company or others in the sector will be impacted by who’s elected president? 

Mr. Mitrani: I don’t think so. All I know is this: Our clinical results have been extremely promising. It’s a therapeutic that our country could use right now. 

TWST: Being a relatively smaller company, what are some of the challenges for a company your size when you’re trying to come up with a therapeutic for something as earth-changing as COVID? 

Mr. Mitrani: If we were going to do 3,000 patients, we’d need over $90 million, maybe $100 million. However, I am certain everything will fall in line. 

I think the biggest problem is, because we’re not a big pharmaceutical company, we tend to hear, “Who is this small biotechnology company?” If we could just get in front of the right people that make the decisions at the top, I think they’d be very, very impressed with our science and technology. We have spoken to many top scientists in the country, and you can see them scratching their heads and say, “How did you guys figure this out?” 

I think the only problem right now is the exposure to people and the government or in the White House, which we are actively working on. 

TWST: Do you think from this entire COVID experience, since the outbreak in China, that the sector and the industry as well as government officials have learned a few lessons for anything that could happen in the future? What might those be? 

Mr. Mitrani: We’re living in a new world. This pandemic has really taught us the importance of science. Particularly, the importance of innovative therapeutics that can be rapidly tested and incorporated into the standard-of-care medicine. When COVID first began, biotechnology groups, such as ours, were tasked with the challenge of deriving solutions to this new virus. 

Fortunately, government institutions, such as the FDA here in the United States, have been extremely open to working with professional groups who have been able to establish a solid foundation for their previously developed therapies, and to repurpose and explore a therapeutic potential for the fight against COVID-19. We have learned through the coordination with various agencies that we can bridge the gap between the research development lab to the clinic while adhering to rigorous scientific methods. 

From the current experience, I feel that the sector as a whole has learned to be more adapt to the rapid development of therapies while still maintaining strong safety and regulatory oversight. It has been truly amazing to see the strong and rapid response from our scientific community to bring the next generation of therapies to the country and the world. 

TWST: Are you proud of your team at the company for coming up with the product and working on it the way it has? 

Mr. Mitrani: It’s really incredible. We’re a small company that’s growing by the day. Everybody is on the same page working, seriously, 20 hours a day nonstop worldwide and with one goal. We just want to help people. We believe we found the key to the lock or the needle in the haystack. We’re just trying to perfect what we have and scale up to help as many people as possible. It’s been a very, very good ride so far. 

TWST: Thank you. (ES) 

ALBERT MITRANI 

CEO 

Organicell Regenerative Medicine, Inc. 

1951 NW Seventh Ave. 

Suite #300 

Miami, FL 33136 

(888) 963-7881 — TOLL FREE 

www.organicell.com 

email: info@organicell.com

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