- Source : Press Release
- Date : 2021-04-07
- Event type : Phase 2
- Companies : CSL, Ltd.
GC Pharma Sticks to Plasma Therapy Study Despite Global Trial Failures
GC Pharma said it would continue to develop hyperimmune globulin drug for Covid-19 despite the recent statement by CoVig-19 Plasma Alliance that it confirmed disappointing results in phase 3 clinical trials.
Takeda, one of the co-leaders of the CoVig-19 Plasma Alliance, said Wednesday that the group has completed the phase 3 Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) clinical trials and decided to end the year-long collaboration as it did not meet the endpoint in the study.
Takeda co-founded the alliance with CSL Behring, whose members also include Ukraine's BioPharma Plasma and GC Pharma, to test the efficacy of plasma-derived therapy combined with remdesivir in severe Covid-19 patients. The two sides conducted the study on about 600 patients in 10 countries.
Although the alliance expressed disappointment with the clinical trials, the analysis of the study results is going on.
"While the results of this particular clinical trial are disappointing, we are proud that as an industry we proactively and collaboratively pursued this work, and that the program may contribute to a growing understanding of this challenging virus and strategies for patient care," said Bill Mezzanotte, executive vice president and head of research and development and chief medical officer at CSL Behring.
GC Pharma explained that the global phase 3 study was separately conducted from its phase-2 study to receive conditional approval from the U.S. Food and Drug Administration and proceeded to the next phase.
The company has been conducting open, randomized, and multi-institutional trials at 13 hospitals, including Samsung Medical Center, Asan Medical Center, Korea University Ansan Hospital, and Seoul Medical Center, with 60 patients to check for safety efficacy profile.
Julie Kim, head of Takeda's plasma-derived therapies business unit and co-leader of the CoVIg-19 Plasma Alliance, said the phase 3 ITAC study did not meet the endpoint, and she decided to disband the CoVig-19 Plasma Alliance.
"We believe this research adds to the community's understanding of this challenging virus and may help inform new strategies for patient care, and we are grateful to colleagues, patients, plasma donors, and many collaborators who made the development and manufacture of the investigational plasma-derived therapy possible," Kim said. "The Alliance has ended, and any new research will require a new clinical study, which is individual members to choose to continue the study independently."
Commenting on the recent failure of the global clinical trial of plasma therapy, however, a Green Cross official said, "We have no official opinion for the global study, and the analysis of our independent phase 2 study would be completed within this months as scheduled."
The official added that the company plans to request conditional use approval by applying phase 3 trials.
"Our plasma therapy development is a national project, and we will push ahead with the research regardless of ITAC study results,” the official said. “The ongoing platform technology of plasma-derived drug can also respond to Covid-19 variants."
The National Institute and Allergy and Infectious Diseases (NIAID) will soon announce the CoVig-19 Plasma Alliance's ITAC study results.