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Food & drink

Naturally Splendid Enterprises moving to selecting subjects for Phase 2 clinical trial to evaluate Cavaltinib as coronavirus treatment

The trial will be run through Plasm Pharmaceutical, which is a joint venture between the health-food focused company and Biologic Pharmamedical

Naturally Splendid Enterprises Ltd (CVE:NSP) (OTCQB:NSPDF) said it was moving towards selecting subjects for the Health Canada approved Phase 2 clinical trial of Cavaltinib as a potential treatment for coronavirus (COVID-19) as final preparation and planning is now complete.

The trial will be run through Plasm Pharmaceutical, which is a joint venture between the health-food focused company and Biologic Pharmamedical.

READ: Naturally Splendid Enterprises ships fifth container of hemp seed to South Korea

In November, 2020, the group announced it had received the go-ahead from Health Canada to proceed with the Phase 2 trial.

Cavaltinib has been shown to inhibit cytokines - small proteins released by many different cells in the body, including those of the immune system. The company believes Cavaltinib will show positive results in mitigating the so-called 'cytokine storm' seen in coronavirus patients.

"We have come a long way from the original research initiative that honed in on the anti-inflammatory pharmacology of the drug in the context of disease pathologies associated with Ulcerative Colitis and other autoimmune-related diseases such as Crohn's, Rheumatoid Arthritis and Lupus," said Franco Cavaleri, lead scientist and the CEO of Plasm Pharmaceutical, in a statement.

"Our first victory round was in achieving approval for anti-inflammatory claims by Health Canada for this novel technology with the intention of engaging in clinical research to demonstrate indication-specific applications to treat these diseases. The opportunity to run a COVID-based phase 2 clinical trial with Cavaltinib, will accelerate the development of this drug for other potential applications as noted".

Naturally Splendid noted that for the original indications of the Cavaltinib technology, it had seen "strong preliminary promise" for: ulcerative colitis, Crohn's disease, asthma, COPD, arthritis and other autoimmune and autoinflammatory conditions.

"Our initial focus is for a COVID treatment. However, we believe the results from this clinical study will also provide valuable data on the effectiveness of Cavaltinib in other applications," added Naturally Splendid CEO Craig Goodwin.

In the statement, Naturally Splendid also drew attention to comments from the President of the European Council Charles Michel, who spoke on Tuesday this week, saying it was "not a question of if the world will see another pandemic, but when".

"COVID-19 has been a harsh reminder - no one is safe until everyone is safe," Michel said, noting that leaders need to take responsibility to ensure that pandemic preparedness and global health systems are fit for the 21st century, highlighted the company.

Contact the author at giles@proactiveinvestors.com

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