VANCOUVER, British Columbia - TheNewswire - November 3, 2020 -- Naturally Splendid Enterprises Ltd. ("Naturally Splendid" or "NSE") (TSXV:NSP) (OTC:NSPDF) (Frankfurt:50N) is pleased to announce that further to the Company's earlier announcements, Health Canada has now provided a Notice of Authorization to proceed with a phase 2 clinical trial for a potential COVID-19 treatment utilizing the target drug CavaltinibTM.
The Authorization Letter received November 2, 2020, follows the completion of a series of Information Request Notices from Health Canada regarding the clinical trial protocols. The Company has now completed all required submissions and documentation required by Health Canada and has final approval to initiate the strategic execution of the phase 2 clinical trial for a potential COVID-19 treatment.
In this regard, the Plasm Pharmaceutical Inc.("PLASM") team has begun the process of assembling the additional team members and third party organisations that will be required to engage in and complete the clinical trial, www.plasmpharma.com.
We are optimistic that Cavaltinib(TM) can be a significant resource as part of a successful treatment plan for COVID-19 positive patients. This treatment option, delivered in capsule form, may mitigate the risk for those who are at high risk of morbidity or mortality. The capsule delivery mechanism may be able to provide hope for patients while reducing the impact on Health Care Services as this form of treatment can be self-administered at home rather than patients being forced to seek treatment in hospitals or clinics.
Franco Cavaleri, Biologic Pharmamedical's ("BIOLOGIC") CEO and Chief Scientist; "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 immune system and inflammatory phenomenon is also similar in many ways to how the pathology of autoimmune diseases play a deleterious role in the overall health of patients with these diseases. We are cautiously hopeful that these studies will also shed light on how this drug might play a role in the functional treatment of these other diseases as well".
Cytokines are small proteins released by many different cells in the body, including those of the immune system where they coordinate 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-2virus behind the COVID-19 pandemic.
Cavaltinib(TM) has been shown to inhibit these cytokines. Research has already shown Cavaltinib(TM) irrefutably inhibits, the NF-kappa-B Signalling Pathway through mechanisms discovered by BIOLOGIC's principle scientist, Franco 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.
PLASM has secured licensing rights for this BIOLOGIC-owned patent that covers 38 countries. PLASM has been conceived and assembled for the purpose of further developing and carrying out clinical trials on the CavaltinibTM-Branded Drug(s) in the specific Field described in the License Agreement. The Field includes but is not limited to treatment and/or prophylaxis of respiratory indications, including COVID-19.
Naturally Splendid owns 16% of the joint venture and will receive a 10% royalty on gross sales of all PLASM products.
PLASM is being positioned to take drug candidates through clinical trial and other pre-market protocols mandated by regulatory agencies. PLASM's first and current subject drug treatment branded Cavaltinib(TM), has shown positive results with published peer-reviewed studies executed and published by BIOLOGIC showcasing the drug's inhibition of inflammatory cytokines central to the COVID-19 pathology.
For almost two years, BIOLOGIC has supplied Naturally Splendid with versions of the patented technology that CavaltinibTM is based on. In this time, the company has gained an excellent overall understanding of the science and technologies that will be utilized in this clinical study. Naturally Splendid's internal research and development scientist, Dr. Mehrab Manteghian, who holds a doctorate of medicine as well a degree in food science, has reviewed the data from the clinical studies on this technology and will continue to be involved through the clinical trial process.
Naturally Splendid CEO Mr. Craig Goodwin summarizes, "This is of course a significant step forward in our pursuit of a COVID-19 treatment made even more important as we see additional waves of the virus continue to spread. The hope remains high that CavaltinibTM will provide relief for those afflicted with COVID. We also anticipate the clinical trial to provide additional indications where CavaltinibTM may be effective".
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's 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, cure or contain 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.
On Behalf of the Board of Directors
Mr. J. Craig Goodwin
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
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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