Naturally Splendid Provides Clinical Trial Application Update
VANCOUVER, British Columbia – TheNewswire - June 19, 2020 -- Naturally Splendid Enterprises Ltd. (“Naturally Splendid”) (TSXV:NSP) (OTC:NSPDF) (Frankfurt:50N) provides the following update in regards to the Phase 2 Clinical Trial Application with Health Canada for a potential COVID-19 treatment.
As an update to the Clinical Trial Application (CTA) process with Health Canada: A CTA was approved for submission to Health Canada on May 17, 2020. The Health Canada drug directorate subsequently moved the application down the appropriate path for review and with this requested more information be submitted to accompany this original application. In response, a set of addendum documents were submitted to meet the request for more data on June 1-2, 2020. Additional documentation was requested, once again, by Health Canada to add to the application and this additional set was submitted June 15, 2020 to meet the data demand. We are encouraged by the communication and facilitation support by Health Canada and anticipates more direction by Health Canada shortly.
Cavaltinib® is expected to serve as a treatment for COVID-19 patients who are at high risk of morbidity and mortality. The drug is a low adverse reaction risk candidate that has been shown in research by Biologic Pharmamedical Research to inhibit transcription factors central to cytokine production; cytokines like IL6, IL1, IL2 and others which, themselves, are central to the cytokine storm phenomenon. Biologic Pharmamedical's work has historically shown the drug's activity to be successful in this context leading to Health Canada's interest and support to facilitate the CTA. Plasm Pharma intends to demonstrate in COVID-19 patients a reduction in cytokine status and with this a reduced risk for morbidity and mortality in high risk COVID-19 patients; and with this also a reduced strain on health care resources.
A joint venture between Naturally Splendid and Biologic will hold the exclusive license to Cavaltinib®. This is the Biologic Pharmamedical treatment plan that has been approved for a fast track Clinical Trial Application (CTA) through Health Canada. While pursuing the opportunity to execute the same or similar clinical trials in the USA, the company has been working on expanding distribution logistics in preparation to meet Cavaltib® demand. The company has aggregated new members of the Scientific Advisory team to expand its resource and expertise base in line with this objective.
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 firstname.lastname@example.org or call Investor Relations at 604-673-9573
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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