FHI Clinical Inc. will be working with the Infectious Disease Research Institute (IDRI), a not-for-profit organization, to provide contract research organization (CRO) capabilities. The trial at the center of the partnership is designed to come up with solutions that can help combat moderate to severe cases of COVID-19.
Ted FitzGerald, CEO of FHI Clinical, told Outsourcing-Pharma that his company is enthusiastic about contributing to a possible treatment for the pandemic-causing virus.
“In this period of crisis, we are incredibly grateful to be able to contribute to understanding of the treatment of COVID-19 through this partnership,” he said.
According to FitzGerald, the companies connected through the Global Health Clinical Consortium (GHCC) FHI Clinical has been a member of the consortium (composed of organizations that develop vaccines, medicines and diagnostics to combat HIV and TB, as well as leprosy and other neglected diseases) since 2011.
Additionally, IDRI also is a long-standing member of the consortium. FitzGerald reported IDRI and FHI Clinical have worked together on previous occasions to improve clinical research of neglected diseases.
FitzGerald added that FHI Clinical is providing project management, medical and clinical monitoring, and data and safety management and analysis for the trial. The study is currently in rapid start-up with the goal of subject enrollment before the US pandemic is expected to decline, he told us.
IDRI recently secured funding from Celularity, a clinical-stage cell therapeutics company, to launch a trial investigating the use of Celularity’s NK cell therapy. The cell therapy is currently being studied for the treatment of various hematologic cancers and solid tumors, as a potential treatment option against the novel coronavirus.
Corey Casper, CEO of IDRI, said that the targeted therapy is hoped to “essentially be a way of giving patients the immune cells that are critical in fighting this infection.” Additionally, he is optimistic that the immunotherapy can be introduced to the market within a year, pending favorable trial results.
