On Nov. 4, 2020, Mateon Therapeutics announced the receipt of approval from Instituto Nacional de Salud (INS), the regulatory agency of Peru, to initiate the Company’s C001- phase 2 clinical trial of OT-101, a TGF-antisense, for treatment of patients with mild to severe COVID-19 infection.

C001 trial is a multi-center, double blind, randomized, placebo-control study to evaluate safety and efficacy of OT-101 in combination with standard of care on two (2) patient cohorts – 1) mild or moderate disease, and 2) severe disease requiring mechanical ventilation or intubation. The study will enroll approximately 48 patients in Peru totaling 72 patients study wide. The primary efficacy endpoint is the proportion of subjects with clinical improvement score (measured by an 8‑point World Health Organization [WHO] COVID‑19 Clinical Improvement Ordinal Scale) as assessed by the Odds Ratio (OR) at Day 14.

On October 19, 2020, Mateon announced the receipt of approval from Republica Argentina – Poder Ejecutivo Nacional of Argentina to initiate the Company’s Phase 2 clinical trial of OT-101 for the treatment of patients with mild to severe COVID-19 infection.