Naturally Splendid Enterprises Ltd (CVE:NSP) (OTCMKTS:NSPDF) said Thursday that its preparation for a Phase 2 clinical trial of Cavaltinib to treat coronavirus (COVID-19) patients is advancing, sending shares higher.
The company said Health Canada has performed an initial review of data for a Clinical Trial Application (CTA) and has advised that the Biologic Division within the agency’s Regulatory Affairs Biologic and Radiopharmaceutical Drugs Directorate is the appropriate channel to continue processing the CTA.
“This significant designation creates a clear path for the CTA to proceed,” Naturally Splendid said in a statement.
READ: Naturally Splendid joins race to find coronavirus treatment as it unveils joint venture plan with Biologic Pharmamedical Research
Cavaltinib is licensed to a joint venture owned by Naturally Splendid and Biologic Pharmamedical Research based on technology and patents developed by Biologic.
The drug has been run through Biologic's research program designed to study key drug targets involved in the regulation of the immune system and inflammatory activity.
Naturally Splendid said the research has already shown Cavaltinib irrefutably inhibits cytokines central to the 'cytokine storm' phenomenon in which the body starts to attack its own cells and tissues rather than just fighting off the virus.
The company has cautioned that it has yet to be proven in a clinical setting that mitigation of the 'cytokine storm' will show the same positive results with COVID-19 patients.
The joint venture will be granted certain rights from Biologic's patents as it relates to applications for treating COVID-19 infections. The categories to be licensed will include, but are not limited to COVID-19 applications, as well as additional respiratory indications that may arise out of the fast-tracked Phase 2 clinical trial.
Shares in Toronto surged 62.5% to C$0.065. In the US, the stock gained 66% to US$0.05.
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