04:36:45 EDT Thu 28 Mar 2024
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or Name
USA
CA



Naturally Splendid Enterprises Ltd
Symbol NSP
Shares Issued 141,438,513
Close 2020-06-18 C$ 0.055
Market Cap C$ 7,779,118
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Naturally sends additional data to Health Canada

2020-06-19 09:33 ET - News Release

Mr. Craig Goodwin reports

NATURALLY SPLENDID PROVIDES CLINICAL TRIAL APPLICATION UPDATE

Naturally Splendid Enterprises Ltd. has provided the following update in regard to the phase 2 clinical trial application with Health Canada for a potential COVID-19 treatment.

As an update to the clinical trial application (CTA) process with Health Canada: A CTA was approved for submission to Health Canada on May 17, 2020. The Health Canada drug directorate subsequently moved the application down the appropriate path for review and with this requested more information be submitted to accompany this original application. In response, a set of addendum documents were submitted to meet the request for more data on June 1-2, 2020. Additional documentation was requested, once again, by Health Canada to add to the application and this additional set was submitted June 15, 2020, to meet the data demand. Naturally Splendid is encouraged by the communication and facilitation support by Health Canada, and anticipates more direction by Health Canada shortly.

Cavaltinib(R) is expected to serve as a treatment for COVID-19 patients who are at high risk of morbidity and mortality. The drug is a low adverse reaction risk candidate that has been shown in research by Biologic Pharmamedical Research to inhibit transcription factors central to cytokine production; cytokines like IL6, IL1, IL2 and others that, themselves, are central to the cytokine storm phenomenon. Biologic Pharmamedical's work has historically shown the drug's activity to be successful in this context leading to Health Canada's interest and support to facilitate the CTA. Plasm Pharma intends to demonstrate in COVID-19 patients a reduction in cytokine status and with this a reduced risk for morbidity and mortality in high-risk COVID-19 patients, and with this also a reduced strain on health care resources.

A joint venture between Naturally Splendid and Biologic will hold the exclusive licence to Cavaltinib(R). This is the Biologic Pharmamedical treatment plan that has been approved for a fast track CTA through Health Canada. While pursuing the opportunity to execute the same or similar clinical trials in the United States, the company has been working on expanding distribution logistics in preparation to meet Cavaltib(R) demand. The company has aggregated new members of the scientific advisory team to expand its resource and expertise base in line with this objective.

About Naturally Splendid Enterprises Ltd.

The company operates a safe quality food level 2 certified food manufacturing facility just outside Vancouver, B.C., in Canada.

We seek Safe Harbor.

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