“The same study protocol is being prepared for submission to the U.S. FDA regulatory authorities.”
Vancouver, British Columbia – TheNewswire – May 26, 2020 – Naturally Splendid Enterprises Ltd. (“Naturally Splendid”, “NSE” or “the Company”) (FRANKFURT:50N) (TSXV:NSP) (OTC:NSPDF) is pleased to provide the following update regarding progress for a Phase 2 clinical trial treatment for COVID 19.
The Company is pleased to announce that a Clinical Trial Application (CTA) has been submitted to Health Canada for a COVID-19 Phase 2 clinical trial, using Cavaltinib(TM) as the subject test drug. The same study protocol is being prepared for submission to the U.S. FDA regulatory authorities.
After an initial review of data for a Clinical Trial Application (CTA), Health Canada has advised that the Biologic Division within the Health Canada Office of Regulatory Affairs Biologic and Radiopharmaceutical Drugs Directorate is the appropriate channel to submit the completed CTA.
The study will be an adaptive pilot to pivotal trial design based on guidance documents from the World Health Organization (WHO) to determine if Cavaltinib(TM) is a viable treatment that can improve clinical symptoms and reduce the number of COVID-19 infected patients from progressing to mechanical ventilation with intubation and death.
The trial will begin as a Phase 2 study and after an interim analysis is performed on the first 40 patients, the data will determine the number of expected patients needed to reach statistical significance in a Phase 3 trial. The Phase 2 portion of the study is expected to last 4 weeks, which will include monitoring of patients and correlating of the data.
With positive preliminary data, the clinical trial would move directly from a Phase 2 into a Phase 3 as guided by Health Canada.
As set out in Naturally Splendid’s news release dated May 19, 2020, Naturally Splendid entered into a letter of intent with Biologic Pharmamedical (Biologic) to form of a joint venture for the purpose of developing and pursuing Phase 2 clinical studies, utilizing one of Biologic’s patented technologies as a candidate for a potential COVID-19 treatment. The proposed joint venture entity will be granted certain rights from Biologic’s patents as it relates to applications for treating COVID-19 infections. The categories to be licensed will include, but are not limited to COVID-19 applications, as well as additional respiratory indications that may arise out of the Phase 2 clinical trial
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.
The scientific content of this news release has been reviewed and approved by Biologic.
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 sales revenues for the first half 2019 exceeded FY2018).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 email@example.com or call Investor Relations at 604-673-9573
On Behalf of the Board of Directors
Mr. J. Craig Goodwin
CEO, President, Director
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; customers will complete on sales contracts; 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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