SAN ANTONIO, Texas--(BUSINESS WIRE)--In an article, “Antiviral Effects of Oleandrin,” published this week in the Journal of Experimental Pharmacology, the authors note the strong antiviral activity against “enveloped” viruses of the cardiac glycoside, oleandrin, in particular oleandrin’s ability to inhibit production of infectious virus particles when used for treatment prior to, as well as after, infection of SARS-CoV-2, the virus that causes COVID-19.
Published reports from in vitro cell culture studies have shown that oleandrin and extracts containing this molecule are effective against HIV, the Ebola virus as well as HTLV-1 and other viruses that are harmful to human health and well-being. The 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.”
The authors continue: “The antiviral efficacy of oleandrin has now been shown against SARS-COV-2 and, if proven safe and effective in appropriate animal models and then in human studies, oleandrin and extracts containing this molecule may offer a unique therapeutic approach to treat COVID-19-related disease.”
The article reviews a series of research studies which establishes the antiviral activity of oleandrin – a unique lipid-soluble molecule derived exclusively from Nerium oleander, which is the active principal ingredient in the patented botanical extract drug PBI-05204 developed by Phoenix Biotechnology, Inc. (www.phoenixbiotechnology.com). This drug has been through both Phase I and Phase II trials (completed in 2016) in patients with malignant disease. These clinical studies demonstrated that oral administration of defined doses of oleandrin can be given to humans without serious adverse effects, suggesting its use for other diseases beyond cancer.
The Journal of Experimental Pharmacology is a peer-reviewed, open access, online journal. Authors of the study are:
- Robert A. Newman, Department of Experimental Therapeutics, The University of Texas M.D. Anderson Cancer Center in Houston, and Chief Science Officer of Phoenix Biotechnology, Inc. in San Antonio;
- K. Jagannadha Sastry, Departments of Thoracic, Head and Neck Medical Oncology and Veterinary Sciences, University of Texas M.D. Anderson Cancer Center in Houston;
- Ravit Arav-Boger – Division of Infectious Diseases, Department of Pediatrics, Medical College of Wisconsin in Milwaukee;
- Hongyi Cai – National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health in Bethesda, Md;
- Rick Matos – Innovar, LLC in Plano, TX; and
- Robert Harrod – Department of Biological Sciences, Dedman College Center for Drug Discovery, Design & Delivery at Southern Methodist University in Dallas.
A recent in vitro report by the University of Texas Medical Branch’s World Reference Center for Emerging Viruses and Arboviruses has shown that oleandrin has a powerful effect against SARS-CoV-2. Prophylactic treatment of Vero cells with as little as 50 ng/mL concentration resulted in a significant 800-fold reduction in virus production, and a 100 ng/mL oleandrin concentration resulted in a greater than 3,000-fold reduction in the infectious titer as well as a similar reduction in viral RNA.
Given reports of long, lingering health impacts from COVID-19 infection, such as cognitive injury and decline as well as heart and lung tissue damage, the authors also note that oleandrin has been shown in earlier studies (conducted Duke University’s Center for Drug Discovery) to readily traverse the blood-brain barrier and induce brain-derived neurotrophic factor (BDNF) which may assist with the recovery from virus-associated neurological disease.
In addition, oleandrin and extracts containing it previously have been shown to produce a strong anti-inflammatory response through the activation of Nrf-2 antioxidant genes, which may be of benefit in preventing hyper-inflammatory responses to infection in patients with COVID-19.
“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 authors state. “. . . 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.”
Among other viruses where oleandrin has shown strong antiviral activity are Ebola and Marburg which are highly pathogenic and are classified as Biosafety level-4 (BSL-4) infectious select agents. A 2017 study by the United States Army Medical Research Institute for Infectious Diseases (USAMRID) which was presented at the International Filovirus Symposium in Marburg, Germany, found that Phoenix Biotechnology’s PBI-05204 and oleandrin “fully inhibited MARV and EBOV infection in Vero cells.”
Preliminary results in other studies have also indicated that PBI-05204 and oleandrin also have antiviral efficacy against other enveloped viruses such as Western equine encephalitis, demonstrating a broad antiviral profile.
About Phoenix Biotechnology, Inc.
Phoenix Biotechnology, Inc., headquartered in San Antonio, has been exploring the health-related benefits of a novel extract of Nerium oleander for the past 20 years. The company has developed a supercritical CO2 extraction of Nerium oleander into a new botanical drug – PBI-05204. This drug has been through initial FDA review and approved for Phase I and Phase II clinical trials which were conducted in the United States. These trials have shown that this oral formulation is safe for administration to patients without undue toxicity. A distinction of PBI-05204 is that research has consistently proven that this drug crosses the blood brain barrier which opens up several potential applications. Extensive research has been done in the following areas: Antiviral, Cancer, and Neurodegenerative Diseases.
Our Response to COVID-19 – We are preparing to respond to our two previous applications that the FDA took issue with on certain provisions that have required us to do further studies .These studies on both hamsters and rats are near conclusion and we will resubmit these applications before year end and in our belief be permitted to go to clinical trials.