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Naturally Splendid Enterprises Ltd
Symbol NSP
Shares Issued 141,438,513
Close 2020-07-29 C$ 0.095
Market Cap C$ 13,436,659
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Naturally gets green light for phase 2 COVID-19 trial

2020-07-29 12:20 ET - News Release

Mr. Craig Goodwin reports

HEALTH CANADA GRANTS NO OBJECTION LETTER TO PROCEED WITH COVID-19 PHASE 2 CLINICAL TRIAL

Naturally Splendid Enterprises Ltd.'s phase 2 clinical trial, as per its proposed joint venture with Biologic Pharmamedical Research for Cavaltinib (see company news release dated May 15, 2020), has been approved for a COVID-19 clinical trial by Health Canada.

The no-objection letter from Health Canada, received July 28, 2020, provides the acknowledgment of drug candidacy and authority to proceed with a phase 2 clinical trial to demonstrate efficacy in this context, with the trial to take place over a 30-day period.

"We are optimistic that Cavaltinib can be a major part of a successful treatment plan for COVID-19-positive patients. With this treatment option for those who are at high risk of morbidity or mortality, we may be able to provide hope, while reducing the impact on health care services and, thus, providing additional time for the scientific community to develop the right vaccines," said Franco Cavaleri, chief executive officer and chief scientist at Biologic Pharmamedical. "Cytokine storms are a common complication not only of COVID-19, but of other respiratory diseases caused by coronaviruses, such as SARS and MERS. In fact, this mechanism of disease development is also similarly central to autoimmune and autoinflammatory diseases. We are excited about the opportunity to contribute to human health at so many levels. The road that has led to this juncture was long and arduous, but the platform for the coming success is solid."

Cytokines are small proteins released by many different cells in the body, including those of the immune system, where they co-ordinate the immune and inflammatory response against infection or other triggers. Sometimes the body's response to the trigger can go into overdrive, and such is the case in the high-risk patients infected by the SARS-CoV-2 virus behind the COVID-19 pandemic.

Cavaltinib has been shown to inhibit these cytokines. Research has already shown Cavaltinib irrefutably inhibits the NF-kappa-B signalling pathway through mechanisms discovered by Mr. Cavaleri. As a consequence of its down regulation, the inhibition of several downstream cytokines ensues; cytokines central to the cytokine storm phenomenon characteristic of the COVID-19 pathology (IL-1, IL-2, IL-3, IL-6 and several other cytokines). Mitigation of this biological activity can help the patient survive the cytokine storm and make it through to the antibody stage.

The definitive agreement for the joint venture, to be called Plasm Pharmamedical Inc., is being finalized and is expected shortly. Biologic will license certain aspects of the patent comprising the corresponding trademark, Cavaltinib, to Plasm. The categories to be licensed will include, but not be limited to, COVID-19 applications as well as respiratory indications that may rise out of the fast-tracked clinical trial.

Naturally Splendid Enterprises will invest $500,000 into the Plasm joint venture for the purpose of supporting the phase 2 clinical trial for a COVID-19 treatment as well as research identifying additional indications of treatment for health conditions, as described above. Naturally Splendid Enterprises will own 16 per cent of the joint venture and receive a 10-per-cent royalty on the gross sales of all product sales by the joint venture.

Plasm is being positioned to take drug candidates through clinical trial and other premarket protocols mandated by regulatory agencies. Plasm's first and current subject drug treatment, Cavaltinib, has shown positive bench results, with published peer-reviewed studies showcasing the drug's inhibition of inflammatory cytokines central to the COVID-19 pathology.

Naturally Splendid's vice-president of operations, Bryan Carson, stated: "Sadly, we have seen the terrible effects that COVID-19 can have on one's health and even be fatal under certain conditions, which is tragic. We are optimistic that Cavaltinib can be a viable treatment. However, we must also not lose sight of the fact that respiratory disease overall is on the rise as our environment evolves and infectious diseases become more pervasive. Although our immediate focus remains a treatment for COVID-19, the applied science that we stand to learn from these trials may have even far more reaching implications in regards to treatment for respiratory disease than our initial goal to mitigate the health implications of COVID-19."

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

About Naturally Splendid Enterprises Ltd.

Naturally Splendid Enterprises 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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