Health Canada Authorizes COVID-19 Phase 2 Clinical Trial for Patented Plant-based Curcumin Extract

Naturally Splendid Enterprises Ltd. (NSP) (TSX: V.NSP, OTCQB: NSPDF, FRA: 50N, Forum) has been granted a “No Objection Letter” (NOL) by Health Canada to proceed with its COVID-19 Phase 2 Clinical Trial for the target drug CavaltinibTM.”

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The Company says it has now submitted the clinical trial design protocol through the joint venture with Biologic Pharmamedical Research.

The Joint Venture is called Plasm Pharmamedical Inc. (PLASM) with the website URL: www.plasmpharma.com.

Biologic will license certain aspects of the patent comprising of the corresponding trademark, CavaltinibTM, to PLASM. The categories to be licensed will include but are not be limited to COVID-19 applications, as well as respiratory indications that may arise out of the fast-tracked clinical trial. In addition to pursuing a COVID-19 treatment, there is optimism that the trial and the ensuing research will help expand the indications for Cavaltinib™ for respiratory conditions such as asthma and COPD, plus potentially reveal mechanisms of activity in cases of autoimmune diseases like colitis, Crohn’s and rheumatoid arthritis.

About CavaltinibTM: Calming the Cytokine Storm

CavaltinibTM is licensed to PLASM owned by Naturally Splendid and Biologic Pharmamedical Research, based on technology and patents developed previously by Biologic. The CavaltinibTM drug candidate has been shown to inhibit Interleukin 6 (IL-6) and several other cytokines central to the ‘cytokine storm’ phenomenon, where the human body begins to attack its own cells rather than just fighting off the virus, as often seen in critically ill COVID-19 patients.

Cytokines are tiny, but nasty, proteins released by many different cells in the body, including those of the immune system where they coordinate the immune and inflammatory response against infection or other triggers. Sometimes the body’s response to the trigger can go into “overdrive” and such is the case-in the high-risk patients infected by the SARS-CoV-2 virus behind the COVID-19 pandemic.

CavaltinibTM displays novel pharmacology discovered by Biologic and has been shown to be a potential fit as a drug candidate for COVID-19 patient treatment. This candidate drug has been run through Biologic’s research program that was designed to study key drug targets involved in the regulation of the immune system and inflammatory activity.

The research has already conclusively shown CavaltinibTM inhibits IL-6 and several other cytokines central to the ‘cytokine storm’ phenomenon.

The Company says it believes CavaltinibTM will show the same positive results in mitigating the cytokine storm with COVID-19 patients.

In conversation with Stockhouse Editorial, Company CEO & Director Craig Goodwin said the evolution to nutraceuticals and the eventual CavaltinibTM COVID-19 treatment was seamless and how they’re confident that CavaltinibTM is able to weather and beat the cytokine storm:

“Our focus right now is on our opportunity with Health Canada and the joint venture we’ve structured that we’re calling PLASM. What we were going to Health Canada with was to propose, and now they’ve accepted, to go for an increased percentage of higher dosage, capsule-delivered treatments for COVID-19. What we’re trying to do is mitigate the cytokine storms.”

Additionally, he says say that there are great opportunities for treatments outside of COVID-19 including conditions involving pain and inflammation, such as osteoarthritis, depression, high cholesterol, a type of liver disease, and even as an aid to weight loss.

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