New Study Presents Evidence of Effectiveness and Safety Of Oleandrin and Phoenix Biotechnology’s PBI-06150 Against SARS-CoV-2

March 17, 2021 10:00 UTC

SAN ANTONIO--(BUSINESS WIRE)-- An article published last week in the Journal of Biomedicine & Pharmacotherapy (www.elsevier.com/locate/biopha; Vol 138 (2021) 111457) presents in vitro evidence for significant inhibition of SARS-CoV-2 by oleandrin and a defined extract of N. oleander (developed by Phoenix Biotechnology, Inc. and designated as PBI-06150), as well as in vivo evidence of the safety and efficacy of PBI-06150.

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The Journal of Biomedicine & Pharmacotherapy is an open access, peer-reviewed medical journal covering medical applications of pharmacology. It was established in 1956 and is published 10 times a year.

The authors of the article titled “Antiviral activity of oleandrin and a defined extract of Nerium oleander against SARS-CoV-2” state, “The potent prophylactic and therapeutic antiviral activities demonstrated here, together with initial evidence of its safety and efficacy in a relevant hamster model of COVID-19, support the further development of oleandrin and/or defined extracts containing this molecule for the treatment of SARS-CoV-2 and associated COVID-19 disease and potentially also for reduction of virus spread by persons diagnosed early after infection.”

They further state, “With continued expansion of the coronavirus (COVID-19) pandemic, caused by severe acute respiratory syndrome 2 (SARS-CoV-2), both antiviral drugs as well as effective vaccines are desperately needed to treat patients at high risk of life-threatening disease . . . Moreover, it is possible that vaccines may require continuous development due to the ongoing mutation of coronavirus into different variants . . . Furthermore, except for Remdesivir, many of the existing antiviral drugs tested to date have shown limited or no efficacy in clinical trials. Thus, identification of safe and effective therapeutic agents that can be effective against SARS-CoV-2 remains an unmet need.”

The article is a collaborative effort which covers the results of two separate studies of the impact of oleandrin and PBI-06150 on SARS-CoV-2. The in vitro study was conducted by scientists at the University of Texas Medical Branch (UTMB) in Galveston, while researchers at Texas Biomedical Research Institute (Texas Biomed) in San Antonio conducted the in vivo study, utilizing golden Syrian hamsters. Both studies were sponsored by Phoenix Biotechnology (www.phoenixbiotechnology.com).

The in vitro study, using Vero cells, found that “prophylactic (pre-infection) oleandrin (as either the pure compound or as the active principal ingredient in PBI-06150) administration at concentrations as low as 0.05 μg/ml exhibited potent antiviral activity against SARS-CoV-2, with an 800-fold reduction in virus production, and a 0.1 μg/ml concentration resulted in a greater than 3000-fold reduction in infectious virus production. The half maximal effective concentration (EC50) values were 11.98 ng/ml when virus output was measured at 24 hours post-infection, and 7.07 ng/ml measured at 48 hours post-infection.”

“Therapeutic (post-infection) treatment up to 24 h after SARS-CoV-2 infection of Vero cells also reduced viral titers, with 0.1 μg/ml and 0.05 μg/ml concentrations causing greater than 100-fold reduction as measured at 48 hours, and the 0.05 μg/ml concentration resulting in a 78-fold reduction. Concentrations of oleandrin up to 10 μg/ml were well tolerated in Vero cells.”

In the in vivo study, the authors state, “We also present in vivo evidence of the safety and efficacy of defined N. oleander extract (PBI-06150), which was administered to golden Syrian hamsters in a preparation containing as high as 130 μg/ml of oleandrin. In comparison to administration of control vehicle, PBI-06150 provided a statistically significant reduction of the viral titer in the nasal turbinates (nasal conchae).”

This journal article follows a November article in the Journal of Experimental Pharmacology which was titled “Antiviral Effects of Oleandrin” and reviewed a series of research studies which establish the antiviral activity of oleandrin, in particular oleandrin’s strong antiviral activity against “enveloped” viruses and its ability to inhibit production of infectious virus particles when used for treatment prior to, as well as after, infection of SARS-CoV-2.

That article states, “The ability of oleandrin to inhibit the relative infectivity of progeny virus particles may offer a unique approach to treating certain viral diseases.”

It further stated “The therapeutic potential of oleandrin and extracts containing this unique molecule against a wide variety of ‘enveloped’ viruses is evident from the preclinical studies reviewed in this article . . . The speed of development and international spread of viruses such as SARS-CoV-2 necessitates consideration of a new strategy against these viruses . . . Having a compound or plant extract with significant demonstrated potential to prevent as well as treat a wide variety of viruses deserves serious consideration.”

About Phoenix Biotechnology, Inc.

Phoenix Biotechnology, Inc., headquartered in San Antonio, has been exploring the health-related benefits of oleandrin, a novel extract of Nerium oleander for more than 20 years.

Research was initiated at the University of Texas MD Anderson Cancer Center for the potential use of this extract against cancer. The company’s research led to the development of a proprietary supercritical CO₂ extract of Nerium oleander into a new botanical drug – PBI-05204.

Extensive research has also been undertaken to determine the efficacy of oleandrin/PBI-05204 as a therapy for neurodegenerative disease as well as viral infections. One of the profound discoveries of the research program is that a key component of this PBI product crosses the blood brain barrier, opening up the possibility of treatment in the areas of cancer, neurodegenerative diseases and as an antiviral product not currently available from any other known drug.

PBI-05204 has been granted an IND through initial FDA review for Phase I and Phase II clinical oncology trials which were conducted in the United States. These trials have shown that this oral formulation is safe for administration to patients without severe toxicity or adverse effects.

In response to the COVID-19 pandemic, the company focused research in 2020 on a potential treatment for this coronavirus. This effort resulted in two submissions to the FDA, one for a nutraceutical and the second for a pharmaceutical product. Preliminary discussions with the FDA have resulted in the request for additional studies to explore both efficacy and safety. These required trials should be completed within the next several months and, assuming the results are positive, we will pursue new applications for both products.

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