Naturally Splendid Announces Inventory Produced for Target Drug, Cavaltinib(TM) for Phase 2 COVID 19 Clinical Trial
(via TheNewswire)
Vancouver, British Columbia - TheNewswire - June 1, 2020 - Naturally Splendid Enterprises Ltd. ("Naturally Splendid", "NSE" or "the Company") (FRANKFURT:50N) (TSXV:NSP) (OTC:NSPDF) is pleased to provide the following progress update for a Phase 2 clinical trial treatment for COVID 19.
The Company is now awaiting notification by Health Canada to proceed to the Phase 2 clinical trial stage, by way of a No Objection Letter (NOL). Health Canada reviews all Clinical Trial Applications and notifies the sponsor within 30 calendar days if the application is found to be deficient. If the application is deemed acceptable, a No Objection Letter (NOL) will be issued within the 30-day review period.
In preparation, the Company has produced the required quantity of Cavaltinib(TM), the target drug for a Phase 2 clinical trial, and holds it in inventory. In addition, agreements with Pharma grade manufacturing facilities with a history of producing products based on Biologic patented technologies, have been put in place allowing for scaling up production capacities in proactive anticipation of much greater volumes of Cavaltinib(TM) being required for Phase 3 clinical studies and/or distribution to patents. Two (2) facilities have been identified in Canada and two (2) facilities in the United States.
This combined manufacturing capacity would be sufficient for commercial production to serve international markets and provide for manufacturing contingency plans should it be required
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.
About CavaltinibTM
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.