NSPDF - Health Canada Provides Authorization Letter for Naturally Splendid JV PLASM Pharmaceutical to Begin COVID-19 Phase 2 Clinical Trial
(TheNewswire)
VANCOUVER, British Columbia - TheNewswire - November 3, 2020 -- Naturally Splendid EnterprisesLtd. ("Naturally Splendid" or "NSE") (TSXV:NSP) (OTC:NSPDF) (Frankfurt:50N) is pleased toannounce that further to the Company's earlier announcements, HealthCanada has now provided a Notice of Authorization to proceed with aphase 2 clinical trial for a potential COVID-19 treatment utilizingthe target drug Cavaltinib TM .
The Authorization Letter received November 2, 2020, follows thecompletion of a series of Information Request Notices from HealthCanada regarding the clinical trial protocols. The Company has nowcompleted all required submissions and documentation required byHealth Canada and has final approval to initiate the strategicexecution of the phase 2 clinical trial for a potential COVID-19treatment.
In this regard, the Plasm Pharmaceutical Inc.("PLASM") teamhas begun the process of assembling the additional team members andthird party organisations that will be required to engage in andcomplete the clinical trial, www.plasmpharma.com .
We are optimistic that Cavaltinib(TM) can be asignificant resource as part of a successful treatment plan forCOVID-19 positive patients. This treatment option, delivered incapsule form, may mitigate the risk for those who are at high risk ofmorbidity or mortality. The capsule delivery mechanism may be able toprovide hope for patients while reducing the impact on Health CareServices as this form of treatment can be self-administered at homerather than patients being forced to seek treatment in hospitals orclinics.
Franco Cavaleri, Biologic Pharmamedical's("BIOLOGIC") CEO and Chief Scientist;" Cytokine storms are acommon complication not only of COVID-19 but of other respiratorydiseases caused by coronaviruses such as SARS and MERS. In fact, thisimmune system and inflammatory phenomenon is also similar in many waysto how the pathology of autoimmune diseases play a deleterious role inthe overall health of patients with these diseases. We are cautiouslyhopeful that these studies will also shed light on how this drug mightplay a role in the functional treatment of these other diseases aswell ".
Cytokines are small proteins released by many different cells in thebody, including those of the immune system where they coordinate theimmune and inflammatory response against infection or other triggers.Sometimes the body's response to the trigger can go into overdrive andsuch 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 thesecytokines. Research has already shown Cavaltinib (TM) irrefutably inhibits, theNF-kappa-B Signalling Pathway through mechanisms discovered byBIOLOGIC's principle scientist, Franco Cavaleri. As a consequence ofits down-regulation the inhibition of several downstream cytokinesensues; cytokines central to the 'cytokine storm' phenomenoncharacteristic of the COVID-19 pathology (IL-1, IL-2, IL-3, IL-6 andseveral other cytokines). Mitigation of thisbiological activity can help the patient survive the 'cytokine storm'and make it through to the antibody stage.
PLASM has secured licensing rights for thisBIOLOGIC-owned patent that covers 38 countries. PLASM has beenconceived and assembled for the purpose of further developingand carrying out clinical trials on the Cavaltinib TM -Branded Drug(s) in thespecific Field described in the License Agreement. The Field includesbut is not limited to treatment and/or prophylaxis of respiratoryindications, including COVID-19.
Naturally Splendid owns 16% of the joint venture andwill receive a 10% royalty on gross sales of all PLASMproducts.
PLASM is being positionedto take drug candidates through clinical trial and other pre-marketprotocols mandated by regulatory agencies. PLASM's first and currentsubject drug treatment branded Cavaltinib(TM), has shown positiveresults with published peer-reviewed studies executed and published byBIOLOGIC showcasing the drug's inhibition of inflammatory cytokinescentral to the COVID-19 pathology.
For almost two years, BIOLOGIC hassupplied Naturally Splendid with versions of the patented technologythat Cavaltinib TM is basedon. In this time, the company has gained an excellent overallunderstanding of the science and technologies that will be utilized inthis clinical study. Naturally Splendid's internal research anddevelopment scientist, Dr. Mehrab Manteghian, who holds a doctorate ofmedicine as well a degree in food science, has reviewed the data fromthe clinical studies on this technology and will continue to beinvolved through the clinical trial process.
Naturally Splendid CEO Mr. Craig Goodwin summarizes, " This is of course a significant stepforward in our pursuit of a COVID-19 treatment made even moreimportant as we see additional waves of the virus continue to spread.The hope remains high that Cavaltinib TM will provide relief for those afflictedwith COVID. We also anticipate the clinical trial to provideadditional indications where Cavaltinib TM may be effective ".
About Cavaltinib TM
Cavaltinib TM displays novel pharmacology discovered byBIOLOGIC and shown today to be a potential fit as a drug candidate forCOVID-19 patient treatment. This candidate drug has been run throughBIOLOGIC's research program that was designed to study key drugtargets involved in the regulation of immune system and inflammatoryactivity. The research has already shown Cavaltinib(TM) irrefutablyinhibits IL-6 and several other cytokines central to the 'cytokinestorm' phenomenon. The Company believes Cavaltinib TM will show thesame positive results in mitigating the 'cytokine storm' with COVID-19patients.
BIOLOGIC's methodology for probing key drug targetswith this novel drug is based on rigorous clinical study that utilizesaccepted allopathic research protocols, thus affirming for medicalpractitioners the efficacy of BIOLOGIC's subject drugs - bothnutraceutical or pharmaceutical - with methods and results that arefamiliar to mainstream medical practitioners.
We caution that this news release is not making any express or impliedclaims that we have the ability to eliminate, cure or contain theSARS-CoV-2 virus at this time.
About Naturally Splendid EnterprisesLtd.
NSE operates a Safe Quality Food Level 2 certified food manufacturingfacility just outside Vancouver, BC in Canada. We have establishednumerous healthy, functional foods under recognized brands such asNatera Sport(TM), Natera Hemp Foods, CHII (TM), Elevate Me(TM) andWoods Wild Bar. The Company has a myriad of new products and lineextensions under development that are approaching launch. NSE has alsodeveloped 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 productsand ingredients focusing on plant-based ingredients. The Companyprovides contract manufacturing services for many global healthy foodcompanies, private labelling a wide variety of nutritional foodproducts destined for global healthy food markets.
For more information e-mail info@naturallysplendid.com or callInvestor 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; 50NFrankfurt)
#108-19100 Airport Way
Pitt Meadows, BC, V3Y 0E2
Office: (604) 465-0548
Fax: (604) 465-1128
E-mail: info@naturallysplendid.com
Website: www.naturallysplendid.com
Forward-LookingStatements
Information set forth in this news release contains forward-lookingstatements that are based on assumptions as of the date of this newsrelease. These statements reflect management's current estimates,beliefs, intentions and expectations. They are not guarantees offuture performance. Naturally Splendid cautions that all forwardlooking statements are inherently uncertain and that actualperformance may be affected by a number of material factors, many ofwhich are beyond Naturally Splendid's control including, NaturallySplendid's ability to compete with large food and beverage companies;sales of any potential products developed will be profitable; sales ofshelled hemp seed will continue at existing rates or increase; theability to complete the sales of all bulk hemp seed purchase orders;and the risk that any of the potential applications may not receiveall required regulatory or legal approval. Accordingly, actual andfuture events, conditions and results may differ materially from theestimates, beliefs, intentions and expectations expressed or impliedin the forward-looking information. Except as required underapplicable securities legislation, Naturally Splendid undertakes noobligation to publicly update or revise forward-looking information.
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