Cavaltinib / Naturally Splendid - LARVOL DELTA

Naturally Splendid Enterprises moving to selecting subjects for Phase 2 clinical trial to evaluate Cavaltinib as coronavirus treatment (Proactiveinvestors) - "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."

Cytokine storm • New P2 trial • Infectious Disease • Novel Coronavirus Disease

Naturally Splendid Enterprises receives Health Canada authorization for COVID-19 trial (Proactiveinvestors) - "Naturally Splendid Enterprises Ltd (CVE:NSP) (OTCQB:NSPDF) announced Tuesday that it has received a Notice of Authorization from Health Canada to proceed with a Phase 2 clinical trial for a potential COVID-19 treatment utilizing the target drug Cavaltinib....The Phase 2 clinical trial will be completed by the Plasm Pharmaceutical Inc (PLASM) team..."

Cytokine storm • New P2 trial • Infectious Disease • Novel Coronavirus Disease

Health Canada Requests Protocol Details of COVID-19 Phase 2 Clinical Trial (Newswire) - "Naturally Splendid Enterprises Ltd....advises that subsequent to Heath Canada issuing a No Objection Letter, they have requested specific protocol details regarding the Clinical Trial Application for Cavaltinib...before the trial may commence. In this regard, Franco Cavaleri...has submitted the requested content to Health Canada, providing additional information outlining protocol details of the phase 2 clinical trial. Once the Clinical Trial Protocol receives approval from Health Canada, the Company will update the timing for the start date of the trial which is anticipated to have a duration of 30 days..."

Clinical protocol • New P2 trial • Infectious Disease • Novel Coronavirus Disease

Naturally Splendid Provides Clinical Trial Application Update (Newswire) - "Naturally Splendid Enterprises Ltd....provides the following update in regards to the Phase 2 Clinical Trial Application....The Health Canada drug directorate...requested more information be submitted to accompany this original application....Additional documentation was requested, once again, by Health Canada.....A joint venture between Naturally Splendid and Biologic will hold the exclusive license to Cavaltinib(R). This is the Biologic Pharmamedical treatment plan that has been approved for a fast track Clinical Trial Application (CTA) through Health Canada."

Canadian regulatory • Cytokine storm • Licensing / partnership • Infectious Disease • Novel Coronavirus Disease

Naturally Splendid Enterprises submits application to Health Canada for phase 2 coronavirus trial (Proactiveinvestors) - "Naturally Splendid Enterprises Ltd...said an application for a Phase 2 trial of Cavaltinib as a treatment for coronavirus (COVID-19) has now been submitted to Health Canada....Cavaltinib has been shown to inhibit IL-6 and several other cytokines central to the 'cytokine storm'....'The trial will begin as a Phase 2 study and after an interim analysis is performed on the first 40 patients....The Phase 2 portion of the study is expected to last 4 weeks'....Naturally Splendid said the same study protocol for a clinical trial was also being prepared to submit to the US Food and Drug Administration."

Canadian regulatory • Cytokine storm • FDA event • New P2 trial • Infectious Disease • Novel Coronavirus Disease