PharmaDrug Inc (CSE:BUZZ) (OTCPINK:LMLLF) announced it has reached an agreement with Southwest Research Institute (SwRI) to initiate clinical and non-clinical manufacturing of Cepharanthine for the company’s rare cancer and infectious diseases programs.
In connection with the company’s recent acquisition of Sairiyo Therapeutics Inc, PharmaDrug has secured an exclusive license from SwRI to develop and commercialize a novel oral formulation of Cepharanthine.
Cepharanthine is a natural product and has been approved for more than 70 years in Japan for a variety of acute and chronic diseases. The natural product has been shown to exhibit multiple pharmacological properties including anti-oxidative, anti-inflammatory, immuno-regulatory, anti-cancer, antiviral and antiparasitic.
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However, the challenge has always been Cepharanthine’s low oral bioavailability, which represents a major obstacle to realizing its full clinical potential. That is why PharmaDrug is focused on advancing the clinical development of an improved oral formulation of Cepharanthine to treat rare cancers and infectious diseases.
Compared to generic Cepharanthine, PharmaDrug’s novel formulation has been shown in rodent and non-rodent models to possess markedly superior bioavailability, meaning it is more easily absorbed by the body.
One potential use for a revamped Cepharanthine is a treatment for esophageal cancer, based on compelling preclinical data and a streamlined path to approval, thanks to a US Food and Drug Administration (FDA) Orphan Drug Designation.
PharmaDrug also plans to initiate high throughput studies to screen a large panel of additional cancers to identify others that are sensitive to the effects of Cepharanthine, either alone or combined with first and second-line chemotherapy drugs.
Additionally, Cepharanthine was recently identified as the most promising of roughly 3,000 approved agents screened in differing cell culture models of the coronavirus by two independent research groups. The drug showed greater potency at inhibiting infection than existing clinical development candidates remdesivir and chloroquine, the company said.
However, because of generic Cepharanthine’s low bioavailability, intravenous administration would normally be necessary, which makes patient access more of a hurdle. A novel oral formulation from PharmaDrug could be useful in this instance as well.
The company said it will initiate discussions with health regulators, including the FDA and Health Canada, to determine the appropriate next steps to advance to human clinical studies that would position Cepharanthine as a potential first-in-class therapeutic against coronavirus and future pandemics.
“We are extremely excited about Cepharanthine and its immense potential,” CEO Daniel Cohen said in a statement. “We are working diligently to advance the drug for Esophageal cancer while simultaneously assessing its potential in other rare cancers. We are also determining our mode of action relating to the drug’s apparent potential in treating COVID-19.”
Contact Andrew Kessel at [email protected]
Follow him on Twitter @andrew_kessel
Story by ProactiveInvestors
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