With over 12 million COVID-19 cases and growing, some physicians become ever more open and innovative in their quest to treat their patients. Take Dr. Allen Meglin, practicing in Savannah, Georgia, who now has internalized the need to deal with the frightening next chapter of COVID-19 for many patients that were infected: that is, the long haulers. TrialSite recently raised this topic. As it turns out, a large number of people that purportedly recover from COVID-19 actually don’t recover fully. Rather, a number of what can be serious symptoms can persist for a long time. That’s why at least this enterprising physician has teamed with Acellular-based therapy venture Organicell and their investigational emergency investigational novel therapy to address COVID-19 patients as well as those fighting the long-hauler phenomena.
Recently, WTOC 11 in Savannah introduced viewers to this important topic as it plays out at Advanced Regenerative Therapies. Back in May, the U.S. Food and Drug Administration (FDA) approved access to Organicell’s treatment via the compassionate use regulatory pathway. By September, an expanded access protocol was approved by the federal health regulator.
Long Hauler Problem
As covered recently in WTOC 11, with nearly 13 million cases in the U.S. alone, a substantial number of these individuals will be afflicted with the long hauler phenomena. With nearly a hundred thousand people infected with SARS-CoV-2 daily during this latest wave of the pandemic, the odds point to a serious need for options for a large patient population. As TrialSite recently reported, one study revealed that it’s possible that between 50% to 80% of COVID-19 patients may continue to experience troubling symptoms up to three months post onset. Concentrated research into the long hauler of course naturally follows primary research into the virus itself. That will change with the introduction of safe and effective vaccines, therapies and more broad-based public health plans. But what is a physician to do now?
TrialSite Tracks Organicell
In the case of this Savannah-based doctor, he has teamed with a Miami, Florida-based regenerative therapy venture profiled before by TrialSite: Organicell. Back on May 30, TrialSite followed the moves of Landmark Hospitals when they filed for compassionate use with the FDA to access an investigational regimen known as Organicell Flow (Zofin). Securing access on a patient by patient basis, this same process is being followed by Dr. Meglin in Savannah. By late September, the FDA granted Organicell expanded access protocol.
Aside from convalescent plasma, Zofin was the first reported acellular therapy to be accepted under the FDA approved expanded access program. This action allowed physicians or hospital to access the investigational product Zofin for patients in outpatient and inpatient facilities infected with SARS-CoV-2 who have mild to moderate COVID-19, or conversely are judged by the healthcare provider to be at high risk of progression to moderate COVID-19.
On Aug. 19, TrialSite’s founder Daniel O’Connor conducted a general question and answer session with the company’s leadership. Summarizing in what is hoped to be a concise, easy to read breakdown, the company described itself as producing “next generation exosome therapeutics.”
Founded by Albert Mitrani (CEO) along with Dr. Mari Mitrani (CSO) and based in Miami, the clinical-stage biopharmaceutical company positions itself in the “regenerative therapy” category, which of course is driven by the stem cell technology-based revolution. As it turns out, stem cells as well as other cell-based therapies possess a regenerative capacity that are now being acted upon by hundreds of regenerative biotech firms worldwide. Based on ongoing preclinical animal-based research as well as early stage clinical trials in humans, already investigational cell-based therapies evidence tissue modulatory effects that can promote regeneration and even healing.
Investigations, according to the Organicell point of view, reveal that stem cell beneficial effects are mainly paracrine-mediated via the release of extracellular vesicles called exosomes. These small, nano-sized vesicles released from cell types transmit various proteins, microRNAs, and other signaling molecules directly to an injury site. As a consequence of this series of discoveries, the regenerative medicine field continues to expand from live cells to acellular exosomes. Enter Organicell that positions itself at the forefront of exosome research through the development of novel manufacturing techniques to isolate and concentrate exosomes for therapeutic and clinical use.
For a discussion of the potential benefits of acellular therapies versus cell-based therapies, follow the link to Dr. Meglin’s practice.
The COVID-19 Response
Of course, like most other companies and research organizations, with the advent of the pandemic came a pivot to contribute to the cause of fighting COVID-19. Previously, Organicell was developing their lead product candidate, Zofin, targeting chronic lung disorder. Given the Miami-based biotech firm was already centering its attention on pulmonary matters, the pivot to research against COVID-19 made sense, especially when the disease develops into its severe form including acute respiratory distress syndrome (ARDS). Early on during the pandemic, company scientists hypothesized that Zofin would be a prime candidate for COVID-19 treatment due to the protein and exosome-rich composition.
They were on the right track and received greenlight from FDA to commence on human trials. After receiving FDA approval as well, the company immediately filed for the emergency and compassionate use IND application to administer their drug to three patients in critical care with COVID-19 infection in the hospital’s ICU. At least during the exchange of information, all patients evidenced marked improvement.
As reported in late September, the recent FDA approval was followed by the treatment of six outpatients treated under the emergency IND regulatory pathway. At least as of Sept. 29, these patients reported significant improvement after treatment with Zofin. The ongoing clinical trial (NCT04384445) can be reviewed here.
Back to the Clinic
Meanwhile, back in Savannah, Georgia, Dr. Meglin has embraced this potential investigational therapy for COVID-19 long haulers. The IV treatment is administered three times four days apart, and the physician describes the investigational product: “Zofin is derived from human amniotic fluid donated from live births. It’s perinatal tissues that’ve been very heavily screened and it contains over 300 growth factors and proteins that regulate your immune system as well as nanoparticles which contains noncoding microRNA. The RNA acts as a signal that tells your immune system how to behave and down regulate.”
Thus far, Dr. Meglin reports only positive results and no negative adverse effects. Of course, it’s too early to tell for sure, and this therapy is very investigational, but the doctor seems quite upbeat, declaring:
“After the first dose there was a dramatic improvement in their mental fog as well as their sense of wellbeing, and then they started to have slight improvement in their oxygenation, which we measured before, during and after the treatment. After their second dose their energy level went up, their stamina went up, they started to continue to feel better and they started to oxygenate even better. After the third dose they started talking about going back to work, it was very interesting how uniform that sentiment was.”
Allen Meglin, MD, earned his Medical Degree at University of Pittsburgh graduating AOA. After completing his surgical and diagnostic radiology internships at Walter Reed Army Medical Center, he went on for additional training in needle placement and minimally invasive procedures at Johns Hopkins Hospital. An author and featured lecturer, the physician has also received several medical device patents. He is the lead physician for a practice called Advanced Regenerative Therapies.
Call to Action: A cautionary note to the TrialSite Network: the potential of regenerative therapy is big but it’s still highly investigational. That means that if there are physicians or practices pitching cures via stem cell or regenerative therapies, understand that they very well may be violating federal law for making such claims.