10:18:55 EDT Thu 28 Mar 2024
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Naturally Splendid Enterprises Ltd
Symbol NSP
Shares Issued 141,438,513
Close 2020-05-21 C$ 0.065
Market Cap C$ 9,193,503
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Naturally receives Health Canada guidance for CTA

2020-05-21 12:44 ET - News Release

Mr. Craig Goodwin reports

NATURALLY SPLENDID PROVIDES UPDATE FOR PHASE 2 COVID 19 CLINICAL TRIAL

Naturally Splendid Enterprises Ltd. has provided the following update regarding preparation for a phase 2 clinical trial treatment for COVID-19 (see news release dated May 19, 2020).

Health Canada has performed an initial review of data for a clinical trial application (CTA) and has advised that the biologic division within the Health Canada Office of Regulatory Affairs Biologic and Radiopharmaceutical Drugs Directorate is the appropriate channel to which the completed CTA can continue its processing. This significant designation creates a clear path for the CTA to proceed.

Cavaltinib, the drug to be evaluated in the clinical trial and licensed to the joint venture owned by Naturally Splendid and Biologic Pharmamedical, is based on technology and patents developed by Biologic. Cavaltinib displays novel pharmacology discovered by Biologic and shown today 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 immune system and inflammatory activity. The research has already shown Cavaltinib irrefutably inhibits IL-6 (interleukin 6) and several other cytokines central to the cytokine storm phenomenon. It is yet to be proven in a clinical setting that mitigation of the cytokine storm will show the same positive results with COVID-19 patients. Biologic has a major university in the United States also participating in a parallel trial.

Biologic Pharmamedical's research methodology for probing key drug targets with these novel drugs is based on rigorous clinical study that utilizes accepted allopathic research protocols, thus affirming for medical practitioners the efficacy of Biologic's subject drugs -- both nutraceutical or pharmaceutical -- with methods and results that are familiar to mainstream medical practitioners.

The referenced joint venture entity 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.

The company cautions that this news release is not making any express or implied claims that it has the ability to eliminate the SARS-CoV-2 virus at this time.

The scientific content of this news release has been reviewed and approved by Biologic.

About Naturally Splendid Enterprises Ltd.

The company operates a safe quality food level 2 certified food manufacturing facility just outside Vancouver, B.C. It has established numerous healthy, functional foods under recognized brands such as Natera Sport, Natera Hemp Foods, CHII, Elevate Me and Woods Wild Bar.

We seek Safe Harbor.

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