Landmark Hospital manages six long-term acute care hospitals across the Southeast United States and recently announced its decision to offer an investigational allogenic biologic product derived from amniotic fluid to patients with advanced COVID-19 conditions under the U.S. Food and Drug Administration (FDA) approved Compassionate Use pathway. Two patients at Landmark Hospital of Athens, Georgia, were treated last week with the first doses of the regimen, known as Organicell Flow. Reports are that intravenous infusions of the biologic product were administered safely to the two patients, and they are clinically stable.
A Key Challenge with COVID-19
The majority of COVID-19 cases are mild, with flu-like conditions for a couple of weeks. However, when cases of COVID-19 do escalate into severe and critical cases, the risk significantly rises for organ damage and death. While the world waits for a safe and effective vaccine, If safe and effective treatments are developed for this class of patient—in addition to the development of safe and effective products for the mild cases—then the overall risk of COVID-19 becomes mitigated until the vaccine is approved.
All of this is important as worldwide experiences direct the medical community to the risks of the severe to critical cases of COVID-19—where a progressive decline in lung function represents a major cause of death in patients infected with SARS-CoV-19; those patients who are admitted into the ICU and thereafter require intubation face high mortality rates. Finding a number of effective and safe ways to treat this patient class, including those with severe Acute Respiratory Distress Syndrome (ARDS) and the overall pandemic risk, wanes as the mortality rate will decline. Hence the importance of the Landmark Hospitals Compassionate Use case discussion.
A Possible Treatment for the ‘Cytokine Storm’?
With severe to critical cases of COVID-19 comes the need for oxygen therapy, mechanical ventilation, and medications to maintain the patient’s blood pressure, reported Landmark Hospitals in a recent press release. But patients at this stage of the disease, especially if they have other risk factors or comorbidities, are at risk of their condition escalating into the so-called cytokine storm. CEO William K. Kapp III, MD, Landmark Hospitals founder, commented, “COVID-19 patients can experience immune activation and the appearance of the cytokine storm syndrome (CSS), which causes damage to lungs and other organs and can lead to death. Landmark Hospitals obtained Compassionate Use approval to administer Organicell Flow because previously collected research showed it might have therapeutic potential in reducing the cytokine activation cycle, which will impact COVID-19 infection severity.”
What is Organicell Flow?
Manufactured by Organicell Regenerative Medicine, Inc., this is a novel treatment derived from human amniotic fluid (HAF) that is voluntarily donated during planned Caesarean section surgeries. The product contains over 300 growth factors, cytokines, and chemokines, as well as hyaluronic acid exosomes.
Is there any comparable treatment on the market for COVID-19?
No. There is currently no specific antiviral therapy available for patients with COVID-19. The FDA-approved Compassionate Use pathway allows for the immediate use of the experimental biologic.
Is this effort like a Clinical Trial?
Yes, it is. The product hasn’t been approved for marketing via the standard process (e.g., three clinical trial phases, filing for marketing, etc.). The product’s maker, Organicell, received Emergency Compassionate Use Investigational New Drug applications (eINDs) by the FDA.
Moreover, as Dr. Kapp quoted in his firm’s press release, Landmark Hospital Athens will be collecting patient data (again under Compassionate Use) and perform ongoing analysis as to the impact—the affect on the two patients—and thus “guide us to interventions that modulate COVID-19 immune response in the lungs and reduce systemic organ damage.”
What are some more details on this Compassionate Use eIND use case?
Upon FDA eIND approval, Landmark Hospital immediately treated the two critically ill COVID-19 patients, in their mid-70s, with the biologic product.
What have been the results thus far?
Landmark Hospital reports that the two patients are clinically stable while the vendor, Organicell, reported in their press release that “Organicell Flow resulted in a remarkable improvement in their clinical status, lung and renal function confirmed by follow up chest X-rays and lab data.” For example, they report that “the patients are no longer intubated” and appear more alert with positive vital signs and oxygenation. Moreover, at least as of this writing, there doesn’t seem to be the organ damage associated with many SARS-CoV-2 cytokine storm cases.
Has Organicell Flow met its primary and secondary endpoints for the Compassionate Use eIND?
Yes. Dr. George Shapiro, Chief Medical Officer of Organicell, reported: “We are very pleased that Organicell Flow, administered intravenously, has to date met all of the primary objectives of safety and secondary clinical objectives of improved ICU status and reduction in the sequential organ failure assessment (SOFA) score.”
Meanwhile, from the provider (site) perspective, Dr. Anthony Sagel, Chief Medical Officer at Landmark Hospital, reported that “The first patient has improved considerably and is now off the ventilator with normal-appearing lungs on their chest X-ray. In addition, their mental status continues to improve with normal kidney function. The second patient has also been systemically improving, including their kidney and respiratory function. Their acute delirium has improved and is communicating well with the family. Both patients are ready to be discharged from the ICU.”
What are the next steps?
The clinical trial protocol established under the eIND is that each of the patients will continue to be monitored on their health vitals for 60 days. Based on the continued favorable results, the product developer, Organicell, may seek other approvals from the FDA to treat other severely ill patients. They will need to do this with the FDA on a case by case basis. Note, the company has registered an FDA-compliant clinical trial with Landmark Hospitals.
The Forthcoming Study
The forthcoming Phase I/II study, sponsored by Organicell, is led by Landmark Hospitals with the purpose to evaluate the safety and potential efficacy of Intravenous Infusion of Organicell Flow for treatment of moderate to Severe Acute Respiratory Syndrome (SARS) related to COVID-19 infection vs. placebo. Scheduled to start in May 2020, the study will run through December 30, 2020. The Principal Investigators will combine Dr. Kapp from Landmark with Dr. Mitrani and Dr. Shapiro from Organicell.
Organicell Flow is a natural and acellular product derived from amniotic fluid and is manufactured to retain the naturally occurring hyaluronic acid, proteins, and exosomes present in perinatal fluid without the addition or combination of a substance or diluent. Organicell products are manufactured in cGMP compliant labs and are tested for sterility, endotoxin levels, hyaluronic acid, protein analysis, and exosomes composition. Exosomes are nano-sized extracellular vesicles that mediate cell-to-cell communication and affect cell function and behavior. For an overview of the science of the product, see this link.
Organicell Regenerative Medicine, Inc.
Publicly traded, Organicell was founded in 2008 by Albert Mitrani, Chief Executive Officer, and Dr. Mary Mitrani, Chief Scientific Officer. Based in Miami, Florida, Organicell is a clinical-stage biopharmaceutical company that harnesses the power of exosomes to develop innovative biological therapeutics for the treatment of degenerative diseases. The company’s proprietary products are derived from perinatal sources and manufactured to retain the naturally occurring exosomes, hyaluronic acid, and proteins without the addition or combination of any other substance or diluent. With under 25 employees, they have three COVID-19 product initiatives in their growing pipeline. With clinical trials, the company previously collaborated with the University of Miami to complete pre-clinical studies in therapeutic areas such as pediatric pulmonary disorder.
A Challenged Past
Publicly traded in the form of a penny stock type of equity asset class, the company must disclose material information to the Securities Exchange Commission (SEC). In their latest 10K, those investors interested can read about the company—how it has faced a tumultuous past attempting to navigate an increasingly regulated world involving the business of selling and distributing regenerative biologic therapies based on proprietary amnion placental tissue-derived products to doctors and hospitals. With toughening regulatory stances from the FDA, (see Section 351 of the Public Health Services Act) the company, on the one hand, was making considerable scientific breakthroughs; but on the other hand, it was short on capital and business talent. The financial considerations are beyond the sphere of this article, but suffice to say the fact that the company is still around to attempt to save COVID-19 patient lives is a testimony to the survival instincts of its two founders (who happen to be spouses)—Albert Mitrani and Dr. Maria Mitrani. 69.48% of this company is controlled by the company’s Board and executive officers Manuel E. Iglesias—via MBC LLC, and executive officers Albert Mitrani, Dr. Maria Mitrani as well as Ian T. Bothwell and Robert Zucker. For those that seek a case study in business intrigue, read the annual statement.
About Landmark Hospitals
Established to form regional hospital referral centers for medically complex patients in need of intensive post-acute care, they established their first regional long-term acute care hospital in Cape Girardeau, Missouri, in 2006 and has steadily grown to seven facilities in four states. They are comprised of the seven operational hospitals, each of which was built in the last eight years. They operate in Missouri, Georgia, Utah, and Florida.
The Organicell Flow Study Lead Research/Investigator
Dr. William Kapp, MD, FAAOS
Call to Action: TrialSite News will monitor the Landmark Hospitals and forthcoming study carefully. The data points currently from the Compassionate Use are only two patients, so no conclusions can be derived. However, if the study commences and most, if not all, of the 20 patients targeted do well, then it becomes more probable that Organicell is on to something special.