Brazilian Health Regulatory Agency (ANVISA) Authorizes Sorrento Therapeutics’ Large Phase 2 Clinical Trial of Abivertinib in Mild, Moderate and Severe COVID-19 Patients
Excerpt from the Press Release:
SAN DIEGO, Oct. 14, 2020 (GLOBE NEWSWIRE) — Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) today announced receipt of clearance from the Brazilian regulatory agency (ANVISA) to proceed with a Phase 2 clinical trial of Abivertinib in mild, moderate and severe COVID-19 patients.
The Brazil study is a Phase 2, Randomized, Double-Blind, Placebo-controlled Study of the Safety and Efficacy of STI-5656 (Abivertinib Maleate) in Subjects Hospitalized Due to COVID-19, particularly looking at the potential clinical benefits of the drug associated with its broad ability (mode of action) to reduce inflammatory cytokine storm. The dose to be tested is the same as in the U.S. Phase 2 trial, but the trial protocol in Brazil includes patients at earlier stages of the disease, with a drug administration regimen of only 7 days (versus 14 days for more advanced patients in the U.S.).
Click the button below to continue reading the Press Release:
Discover What Sets TrialStat Apart From Ordinary Data Management
Click the image or button below to explore our interactive infographic which illustrates the comprehensive and unique capabilities of the TrialStat eClinical Suite.
Request Your Demo Today!
From rapid database build through database lock, we deliver consistent quality on-time and on-budget. Ready to upgrade your eClinical toolkit?