22:25:03 EDT Fri 19 Apr 2024
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Naturally Splendid files CTA with Health Canada

2020-05-26 10:57 ET - News Release

Mr. Craig Goodwin reports

NATURALLY SPLENDID ANNOUNCES CLINICAL TRIAL APPLICATION SUBMITTED TO HEALTH CANADA FOR PHASE 2 COVID 19 CLINICAL TRIAL

Naturally Splendid Enterprises Ltd. has provided the following update regarding progress for a phase 2 clinical trial treatment for COVID-19.

A clinical trial application (CTA) has been submitted to Health Canada for a COVID-19 phase 2 clinical trial, using Cavaltinib as the subject test drug. The same study protocol is being prepared for submission to the United States Food and Drug Administration's regulatory authorities.

After an initial review of data for a 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 to determine if Cavaltinib 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 four 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 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 Naturally Splendid Enterprises Ltd.

The company operates a safe quality food level 2 certified food manufacturing facility just outside Vancouver, B.C. It has established numerous healthy, functional foods under recognized brands such as Natera Sport, Natera Hemp Foods, CHII, Elevate Me and Woods Wild Bar.

We seek Safe Harbor.

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