Is It Time To Pay Attention To This Acellular Biologic Pioneer That Says Its Clinical Trials Are Cheaper And Easier?

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During the peak of the deadly COVID-19 pandemic, one novel therapeutic that seems to have played an important role in helping save lives was Organicell Regenerative Medicine Inc.’s OCEL Zofin™.

Even though COVID-19 therapies and vaccines have been dominated by big players like BioNTech SE — ADR BNTX, Johnson & Johnson JNJ, Moderna Inc. MRNA and Pfizer Inc. PFE, the U.S. Food and Drug Administration (FDA) approved Zofin™ to be used for patients — some whose conditions were serious and life-threatening.

The company hit a significant milestone in October 2020 when the FDA granted expanded access for patients to be treated with their flagship therapeutic, Zofin™. The FDA gave Emergency Investigational New Drug (eIND) approval for treating COVID-19. The investigational product was used for patients with mild to moderate COVID-19 or who were judged to be at high risk of progression to moderate disease.

Zofin™, manufactured to retain naturally occurring microRNAs without adding any other substance or diluent, was reportedly among the first reported acellular therapies accessed under the FDA’s approved expanded access program.

The FDA approval followed the treatment of six outpatients treated under investigational new drugs (INDs) status with Zofin™.

Organicell reported chalking up another win when in May 2021, the Drug Regulatory Authority of Pakistan approved Zofin™ for use with patients on compassionate grounds following the patient’s COVID-19 diagnosis and admittance to an intensive care unit for treatment on a ventilator.

These huge stamps of approvals from major regulatory authorities seem to have put the spotlight on Organicell, indicating that it could be doing something extraordinary and is a company to watch.

The devastating impact of the COVID-19 pandemic on humanity and the global economy has triggered a sudden wake-up call for an all-hands-on-deck approach to developing vaccines and therapies to shore up humanity’s immunity against present and future viruses. Companies like Organicell could play a key role.

For most investors, identifying publicly-traded companies like Organicell with the most promising prospects for converting research and development initiatives into commercial remedies could pay off.

What Makes Organicell Different?

Based in Nova Southeastern University’s (NSU) Center for Collaborative Research, Organicell is a clinical-stage research company with a mission to be the first company to prove the efficacy of extracellular vesicles (EVs) — also known as exosomes — in clinical trials for several conditions.

The fully integrated clinical-stage biotechnology company says it is committed to researching, developing and manufacturing new biologic medicine, focusing on current and potential regenerative therapeutics.

Comprised of two arms — clinical research and commercial — Organicell generates revenue by extracting and delivering potent formulas of EVs for topical, skincare applications.

The company reports that its proprietary products are derived from perinatal sources and manufactured to retain the naturally occurring exosomes, hyaluronic acid, growth factors, and key proteins without adding or combining any other substance or diluent.

Zofin™

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 a.k.a Long Haulers.

Through the FDA’s single-patient emergency and compassionate use mechanism, Organicell has treated 18 subjects to observe Zofin™ safety while secondarily observing clinical improvements.

Zofin™ was administered intravenously to these patients, who were followed for 28 days post-therapy. Under expanded access, Zofin™ has been administered to patients with mild to moderate COVID-19 infections.

These studies demonstrate the first use of a human perinatal-derived nanoparticle biologic as a safe and potentially efficacious treatment for acute respiratory distress syndrome induced by COVID-19 infection.

Cheaper And Easier Clinical Trials?

According to Organicell, Zofin™ is naturally derived and, therefore, only requires 30 patients to complete Phase I/II trials of clinical trials.

Phase III trials should require only 250-300 patients, while clinical trials are currently enrolling and anticipated to be completed within 24 months.

Clinical trials are a crucial element of the drug development process, but they are often expensive, with costs running into hundreds of millions of dollars.

Organicell says its trials are cheaper and faster than those of other companies. The company reports that the cost per trial is approximately $10 million with only 250-350 patients needed, compared to others that cost hundreds of millions of dollars and involve more patients.

“When people hear about clinical trials, they immediately get spooked because they think hundreds of millions of dollars and tens of thousands of patients,” Organicell’s President and Acting CEO Matt Sinnreich told Benzinga. “Since we are a biologic, we have a much smaller requirement.” 

With an entire clinical trial costing about $10 million, Sinnreich believes the company is “well positioned to get Phase I / Phase II enrolled and has a board of directors that can help with additional funding needs.”

Apart from Zofin™, Organicell is also working on PPX, Factor X, and XoTin. The company says it is looking at health and beauty partnerships, clinical trials to pursue a Biologics License Application (BLA), and evolving the science to address other specific ailments.

Unlike other companies that may be spending on speculative research, Organicell says it is already generating revenue with an ultimate goal to uplist soon.

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Featured photo by PhotobyTawat on Shutterstock

Certain of the statements contained in this press release should be considered forward-looking statements within the meaning of the Securities Act of 1933, as amended (the "Securities Act"), the Securities Exchange Act of 1934, as amended (the "Exchange Act"), and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are often identified by the use of forward-looking terminology such as "will", "believes", "expects", "potential", or similar expressions, involving known and unknown risks and uncertainties. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, they do involve assumptions, risks and uncertainties, and these expectations may prove to be incorrect. We remind you that actual results could vary dramatically as a result of known and unknown risks and uncertainties, including but not limited to: potential issues related to our financial condition, competition, the ability to retain key personnel, product safety, efficacy and acceptance, the commercial success of any new products or technologies, success of clinical programs, ability to retain key customers, our inability to expand sales and distribution channels, legislation or regulations affecting our operations including product pricing, reimbursement or access, the ability to protect our patents and other intellectual property both domestically and internationally, and other known and unknown risks and uncertainties, including the risk factors discussed in the Company's periodic reports that are filed with the SEC and available on the SEC's website (http://www.sec.gov). You are cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these risk factors. Specific information included in this press release may change over time and may or may not be accurate after the date of the release. Organicell has no intention and specifically disclaims any duty to update the information in this press release.