Naturally Splendid Announces LOI for Joint Venture with Biologic Pharmamedical Research for COVID 19 Clinical Trial
Vancouver, British Columbia – TheNewswire - May 19, 2020 - Naturally Splendid Enterprises Ltd. ("Naturally Splendid", “NSE” or “the Company”) (FRANKFURT:50N) (TSXV:NSP) (OTC:NSPDF) is pleased to announce that it has entered into a Letter of Intent with Vancouver based Biologic Pharmamedical Research (“Biologic”) to form a joint venture for the purpose of further developing and pursuing phase 2 clinical studies, utilizing one of Biologic’s patented technologies as a candidate for a potential COVID 19 treatment.
The 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 fast-tracked phase 2 clinical trial.
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.
Naturally Splendid will own 16% of the joint venture as well as be granted a 10% royalty on gross sales of all products and applications arising from the clinical study. Biologic will own 82% of the joint venture with 2% assigned to key personnel within Biologic at their discretion.
The Company has been working cooperatively to support Biologic on its plan to conduct COVID-19 phase 2 clinical studies in Canada, US and abroad with its patented pharmacological technology. Although no guarantee to be accepted, Biologic has been given the go ahead to fast track a CTA (Clinical Trial Application) with Health Canada, after their preliminary review of the data.
Biologic has supplied Naturally Splendid with versions of this patented technology for almost two (2) years. In this time, the Company has gained an excellent overall understanding of the science and technologies that will be utilized in this clinical study. The Company’s internal R&D Scientist, Mehrab Manteghain, who holds a Doctorate of Medicine degree as well a degree in food science, has reviewed the data from the clinical studies on this technology and will be actively involved as they pursue and complete clinical trials.
Terms of Joint Venture
The joint venture entity will be granted certain license rights from Biologic patents as it relates to applications for treating COVID 19 infections. The categories to be licensed will include, but are not be limited to COVID 19 applications as well as additional respiratory indications that may arise out of the fast tracked clinial trial. Biologic will also continue to run an in vitro program on tissue and cell models to further expand knowledge on pharmacological mechanisms associated with treatment of other indications such as: rheumatoid arthritis, ulcerative colitis, Crohn’s disease and/or other autoimmune or autoinflammatory diseases of which the technologies and/or products related to the findings of the clinical study will be licensed into the the joint venture on similar terms.
It is expected the initial clinical trial phase directly related to COVID 19 will take 30 to 90 days with the balance of the studies over the twelve month period intended to further expand the pharmacology. Under the proposed joint venture, NSP will invest $500,000 CDN cash into the joint venture for the purpose of.:
(a)preparing documentation for submission of the CTA to Health Canada.
(b)preparation of formal phase 2 clinical trials
(c)$100,000 CDN for inventory of the Covid- 19 treatment product for phase 2 clinical trials;
(d)ongoing clinical trials and further research and development for a period of twelve (12) months overseen by Biologic; and
(e)preparing documentation for pre-IND application for a phase 2 COVID-19 clinical trial with the U.S. FDA.
(f)preparing and executing our own internal pilot trial
The pandemic has placed a strain on the health care system at multiple levels including the well-defined ventilator and intensive care unit (ICU) bottlenecks.
This proposed treatment is an amplified variant of a current Biologic technology that leverages the Biologic patent, that taken in capsule form, would greatly reduce or eliminate the need for virus infected patients to congregate in hospitals or clinics for infusions or other complex treatments. The resulting benefit of this type of capsule delivery mechanism, would make distribution of the treatment far more effective, at a fraction of the cost of treatment requiring hospitalization, which in turn could provide an extra layer of safety for front line medical staff.
The scientific content of this news release has been reviewed and approved by Biologic.
About Naturally Splendid Enterprises Ltd.
NSE has established numerous healthy, functional foods under recognized brands such as Natera Sport™, Natera Hemp Foods, CHII ™, Elevate Me™ 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 firstname.lastname@example.org 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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