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TICKERS: RVV; RVVTF

Life Sciences Firm Gains Protocol Approval for Phase 3 COVID-19 Study
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Revive Therapeutics reported that a renowned independent institutional review board has approved its proposed Phase 3 clinical trial protocol for Bucillamine in COVID-19.

Revive Therapeutics Ltd. (RVV:TSX.V; RVVTF:OTCMKTS), in a news release announced that "the company's Phase 3 clinical trial protocol to evaluate the safety and efficacy of Bucillamine in patients with mild-moderate COVID-19 received approval from the independent Institutional Review Board (IRB) at Advarra, a premier IRB services company in North America."

Revive Therapeutics' CEO Michael Frank stated, "With the IRB approval of the Phase 3 study protocol for COVID-19, we can recruit U.S. clinical sites efficiently, allowing us to move forward with providing Bucillamine to patients under our IND that was approved by the FDA last month."

The firm explained that IRBs are FDA registered constituted groups that operate under FDA regulations and are officially designated to review and monitor biomedical research involving human subjects. An IRB holds the authority to approve, require modifications or disapprove research and the primary purpose of an IRB review is to assure from start to finish that appropriate steps are taken during clinical trials to protect the rights and welfare of participating subjects.

The company stated it plans to enroll up to 1,000 patients it its Phase 3 multi-center double-blind clinical trial of Bucillamine in Patients with Mild-Moderate COVID-19. Patients in the study will be randomized to receive either 100 mg or 200 mg of Bucillamine or placebo three times per day for 14 days. The firm advised that the study's primary objective is to compare the frequency of hospitalization or death in patients with mild-moderate COVID-19 receiving Bucillamine therapy versus those receiving a placebo.

The company advised that an independent data and safety monitoring board (DSMB) will perform an interim analysis after 210 patients have been treated and followed up for 28 days after randomization. After that period, the dosage level which demonstrated the best results will be chosen and randomized at a 2:1 ratio versus placebo. The DSMB will closely monitor the data and will perform additional interim analyses after 400, 600, and 800 patients complete their respective 28-day treatments.

Revive Therapeutics stated that it is specifically not making claims of any kind that its product has the ability to cure or eliminate COVID-19 (SARS-2 Coronavirus).

The company discussed the scientific basis behind the use of Bucillamine (N-(mercapto-2-methylpropionyl)-l-cysteine) for COVID-19 treatment and noted that "preclinical and clinical studies have demonstrated that reactive oxygen species contribute to the destruction and programmed cell death of pulmonary epithelial cells."

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Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: Revive Therapeutics. Click here for important disclosures about sponsor fees.
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5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases. As of the date of this article, officers and/or employees of Streetwise Reports LLC (including members of their household) own securities of Revive Therapeutics, a company mentioned in this article.
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