logo-loader
viewNaturally Splendid Enterprises Ltd.

Naturally Splendid updates investors on Health Canada application for Phase 2 Cavaltinib trial for coronavirus

The Phase 2 portion of the study is expected to last four weeks, which will include monitoring of patients and correlating the data

Naturally Splendid Enterprises Ltd. - Naturally Splendid updates investors on Health Canada application for Phase 2 Cavaltinib trial for coronavirus
Naturally Splendid said the same study protocol for a clinical trial was also being prepared to submit to the US Food and Drug Administration

Naturally Splendid Enterprises Ltd (CVE:NSP) (OTCMKTS:NSPDF) said Friday that it was “encouraged” by the communication and support shown by Health Canada and expects more direction “shortly” on its application for a Phase 2 trial of Cavaltinib as a treatment for coronavirus (COVID-19).

A clinical trial application (CTA) was approved for submission to Health Canada on May 17. The drug directorate moved the application along the path for review and asked for more information. In response, the company submitted a set of documents at the start of June.

Once again, additional documentation was requested by Health Canada and was speedily added by the company to the original application on June 15.

READ: Naturally Splendid Enterprises submits application to Health Canada for Phase 2 coronavirus trial

“We are encouraged by the communication and facilitation support by Health Canada and anticipate more direction by Health Canada shortly,” the company said in a statement.

Cavaltinib is licensed to a joint venture owned by Naturally Splendid and Biologic Pharmamedical Research based on technology and patents developed by Biologic.

The Cavaltinib drug candidate has been shown to inhibit IL-6 and several other cytokines central to the 'cytokine storm' phenomenon, where the body starts to attack its own cells rather than just fighting off the virus, seen in critically ill COVID-19 patients.

“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,” said the company.

If preliminary data is positive, the trial would move directly from a Phase 2 trial into Phase 3.

Naturally Splendid said the same study protocol for a clinical trial was also being prepared to submit to the US Food and Drug Administration.

The company said it has “aggregated new members of the scientific advisory team to expand its resource and expertise base in line with this objective.”

Contact the author Uttara Choudhury at [email protected]

Follow her on Twitter: @UttaraProactive

Quick facts: Naturally Splendid Enterprises Ltd.

Price: 0.07 CAD

TSX-V:NSP
Market: TSX-V
Market Cap: $12.9 m
Follow

Add related topics to MyProactive

Create your account: sign up and get ahead on news and events

NO INVESTMENT ADVICE

The Company is a publisher. You understand and agree that no content published on the Site constitutes a recommendation that any particular security, portfolio of securities, transaction, or investment strategy is...

In exchange for publishing services rendered by the Company on behalf of Naturally Splendid Enterprises Ltd. named herein, including the promotion by the Company of Naturally Splendid Enterprises Ltd. in any Content...

FOR OUR FULL DISCLAIMER CLICK HERE

Watch

Naturally Splendid passes audit to maintain its Safe Quality Food Level 2...

Naturally Splendid (CVE: NSP-OTC: NSPDF) CEO Craig Goodwin joined Steve Darling from Proactive Vancouver to discuss the company once again passing their annual audit that certifies their Pitt Meadows, BC operation as a Safe Quality Food Level 2 certified food manufacturing facility. Goodwin...

on 8/7/20

2 min read