Health Canada Requests Protocol Details of COVID-19 Phase 2 Clinical Trial

- August 10th, 2020

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 CavaltinibTM, the target drug of the proposed joint venture with Biologic Pharmaceutical Research, before the trial may commence In this regard.

Naturally Splendid Enterprises Ltd. (“Naturally Splendid” or “NSE”) (TSXV:NSP) (OTC:NSPDF) (Frankfurt:50N) advises that subsequent to Heath Canada issuing a No Objection Letter, they have requested specific protocol details regarding the Clinical Trial Application for CavaltinibTM, the target drug of the proposed joint venture with Biologic Pharmaceutical Research, before the trial may commence.

In this regard, Franco Cavaleri, lead researcher for the CavaltinibTM technology, 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, with an additional 15 days to process, review and report the findings.

Franco Cavaleri states, “We are fortunate to be operating in a country with such a robust healthcare system that is still agile enough to move swiftly to serve and protect its citizens. We are excited to be working with the Health Directorate of Health Canada to fine tune the trial details to meet regulatory parameters and in more general terms to be given the opportunity to contribute to community, the nation and hopefully beyond that to countries needing the support we may be able to offer”.

The need for treatment for COVID-19 remains critical as the pandemic continues to inflict health and economic damage across the globe with many countries still reporting a rise in COVID-19 cases and a growing number of fatalities.

While the world anxiously awaits a vaccine, it is imperative to find suitable treatment to mitigate the more severe health complications arising from COVID-19. Treatment is the focus of CavaltinibTM, the drug that is being prepared for a phase 2 clinical trial. One of the key advantages of CavaltinibTM is that delivery is by way of capsule, thus significantly reducing the strain on the healthcare facilities, as treatment can be administered at home and there is no need for multiple or long lasting stays in hospitals or clinics to receive treatment.

Reducing the strain on healthcare services will in turn allow hospitals to concentrate on the more acute cases while also resuming a more normalized routine at clinics and hospitals. In addition, it is now being speculated that this COVID-19 crisis is more a model of what we might see repeat itself in the future more often than we have seen in the past. Cavaltinib(TM) may play a broader role to be applied in these cases or even other types of respiratory disease as a treatment or prophylactic application.

In unprecedented fashion, the pharmaceutical industry has come together in an attempt to commercialize a vaccine faster than has been done any other time in the history of medicine. There are several promising vaccine trials in process and there is reserved optimism that a vaccine will be ready for 2021.

However, should a vaccine or vaccines be approved for the general public, there are two challenging factors to obtaining herd immunity or group protection; a lack of capacity to vaccinate a significant amount of the population in a timely fashion; and concerns in the general population regarding the long-term safety of a vaccine that has not gone through the normal process for approval.

Recent polls have found as few as 50% of people in the United States are committed to receiving a vaccine, with another quarter wavering. For some diseases, herd immunity can go into effect when 40 percent of the people in a population become immune to the disease, such as through vaccination. But in most cases, 80 to 95 percent of the population must be immune to the disease to stop its spread.

About CavaltinibTM

CavaltinibTM 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(TM) irrefutably inhibits IL-6 and several other cytokines central to the ‘cytokine storm’ phenomenon. The Company believes CavaltinibTM will show the same positive results in mitigating the ‘cytokine storm’ with COVID-19 patients.

Biologic Pharmamedical’s research methodology for probing key drug targets with this novel drug 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.

We caution that this news release is not making any express or implied claims that we have the ability to eliminate the SARS-CoV-2 virus at this time.

About Naturally Splendid Enterprises Ltd.

NSE operates a Safe Quality Food Level 2 certified food manufacturing facility just outside Vancouver, BC in Canada. We have established numerous healthy, functional foods under recognized brands such as Natera Sport(TM), Natera Hemp Foods, CHII (TM), Elevate Me(TM) and Woods Wild Bar. The Company has a myriad of new products and line extensions under development that are approaching launch. NSE has also developed proprietary technologies for the extraction of high demand, healthy omega 3 and 6 oils from hemp. NSE is the current “go-to” manufacturer for healthy, functional food products and ingredients focusing on plant-based ingredients. The Company provides contract manufacturing services for many global healthy food companies, private labelling a wide variety of nutritional food products destined for global healthy food markets.

For more information e-mail or call Investor Relations at 604-673-9573

On Behalf of the Board of Directors

Mr. J. Craig Goodwin

CEO, Director

Contact Information

Naturally Splendid Enterprises Ltd.

(NSP – TSX Venture; NSPDF – OTCQB; 50N Frankfurt)

#108-19100 Airport Way

Pitt Meadows, BC, V3Y 0E2

Office: (604) 465-0548

Fax: (604) 465-1128



Forward-Looking Statements

Information set forth in this news release contains forward-looking statements that are based on assumptions as of the date of this news release. These statements reflect management’s current estimates, beliefs, intentions and expectations. They are not guarantees of future performance. Naturally Splendid cautions that all forward looking statements are inherently uncertain and that actual performance may be affected by a number of material factors, many of which are beyond Naturally Splendid‘s control including, Naturally Splendid‘s ability to compete with large food and beverage companies; sales of any potential products developed will be profitable; sales of shelled hemp seed will continue at existing rates or increase; the ability to complete the sales of all bulk hemp seed purchase orders; and the risk that any of the potential applications may not receive all required regulatory or legal approval. Accordingly, actual and future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. Except as required under applicable securities legislation, Naturally Splendid undertakes no obligation to publicly update or revise forward-looking information.


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