- Ethics Committee approval to proceed with Phase 3 clinical trial in Turkey
- 13 clinical sites selected to date in Turkey
TORONTO, Feb. 14, 2022 – Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to provide an update on the Company’s U.S. Food & Drug Administration (“FDA”) Phase 3 clinical trial (the “Study”) (NCT04504734) to evaluate the safety and efficacy of Bucillamine, an oral drug with anti-inflammatory and antiviral properties, in patients with mild to moderate COVID-19.
The Company, in collaboration with Delta Health, has recently received approval for the Study by the Ethics Committee of Istinye University in Turkey where the study activities are ongoing. The Company is working with MLP Care, the largest hospital group in Turkey, and Istinye University with access to 30 clinical research sites and over 6000 in-patient hospital beds.
The Company has initially selected the following 13 clinical research sites in Turkey:
- Istinye University Faculty of Medicine
- Liv Hospital Vadi İstanbul
- VM Medical Park Samsun Hospital
- Liv Hospital Samsun
- Medical Park Ankara Hospital
- VM Medical Park Maltepe Hospital
- Istinye University Research Hospital
- Medical Park Göztepe Hospital Complex
- Aydin University Research Hospital
- VM Medical Park Pendik Hospital
- Medical Park Bahçelievler Hospital
- VM Medical Park Mersin Hospital
- Medical Park Antalya Hospital Complex
Covid-19 infections in Turkey continues to grow. Turkey has recorded 12.8 million Covid-19 infections and about 90,000 deaths. The seven-day average of daily Covid-19 infections and Covid-19 deaths is approximately 98,000 and 250, respectively.
Michael Frank, CEO of the Company commented, “Our expansion to Turkey is important to our enrollment goals and commercialization initiatives in the U.S. and international markets.”
The Company is not making any express or implied claims that its product has the ability to eliminate or cure COVID-19 (SARS-2 Coronavirus) at this time.
About Revive Therapeutics Ltd.
Revive is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, and it is prioritizing drug development efforts to take advantage of several regulatory incentives awarded by the FDA such as Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations. Currently, the Company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19. With its acquisition of Psilocin Pharma Corp., Revive is advancing the development of Psilocybin-based therapeutics in various diseases and disorders. Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory diseases and the company was granted FDA orphan drug status designation for the use of Cannabidiol (CBD) to treat autoimmune hepatitis (liver disease) and to treat ischemia and reperfusion injury from organ transplantation. For more information, visit www.ReviveThera.com.
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Neither the Canadian Securities Exchange nor its Regulation Services Provider has reviewed or accepts responsibility for the adequacy or accuracy of this release.
This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Revive’s current belief or assumptions as to the outcome and timing of such future events. Forward looking information in this press release includes information with respect to the the Company’s cannabinoids, psychedelics and infectious diseases programs. Forward-looking information is based on reasonable assumptions that have been made by Revive at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Revive is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Reference is made to the risk factors disclosed under the heading “Risk Factors” in the Company’s annual MD&A for the fiscal year ended June 30, 2021, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.