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Capricor Initiates Compassionate Use Program for Severe COVID-19 Patients using CAP-1002, its Novel Cell Therapy
-CAP-1002 Aims to Mitigate Severe Inflammatory Response Associated with COVID-19- -Expanded Access Protocol Submitted to FDA- LOS ANGELES, April 03, 2020
About this update from Capricor Therapeutics, Inc.
[{"type":"text","content":"\n -CAP-1002 Aims to Mitigate Severe Inflammatory Response Associated with COVID-19- -Expanded Access Protocol Submitted to FDA- LOS ANGELES, April 03, 2020 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR) a clinical-stage biotechnology company focused on the development of first-in-class biological therapeutics for the treatment or prevention of serious diseases, today announced it is providing CAP-1002, its novel cell therapy to patients with advanced COVID-19 under the compassionate use pathway. Two patients were treated last week at a leading healthcare center in Los Angeles, California with additional patients planned in the coming weeks. Infusions of CAP-1002 were administered safely and patients are currently clinically stable. “Physicians leading the fight against COVID-19 patients approached Capricor to discuss the use of CAP-1002 due to its strong immunomodulatory capabilities. They believe that the use of CAP-1002 for the treatment or attenuation of ARDS pneumonia in COVID-19 patients is based on solid scientific rationale and pre-clinical data. We know from previously published pre-clinical data that CAP-1002 mitigates the release of anti-inflammatory cytokines as well as macrophage activation in a number of models of inflammation including sepsis and autoimmune diseases. It is believed that COVID-19 induced ARDS pneumonia is a response to exaggerated and sustained cytokine storm. As such, we are hopeful that CAP-1002 will be of value to patients with respect to the treatment of COVID-19,” said Linda Marbán, Ph.D., Capricor’s president and chief executive officer. The compassionate use act allows FDA to immediately collect information on experimental treatments and then make the appropriate decisions about the safety and efficacy of those treatments. Physicians plan to re-dose patients as well as treat additional patients in the coming weeks. Additionally, Capricor has submitted an expanded access Investigational New Drug (IND) application to investigate the use of CAP-1002 in certain COVID-19 patients which is currently under review with the FDA. Dr. Marbán added, “In addition, we are continuing our efforts in developing our exosome platform technology as a potential COVID-19 vaccine and remain committed to advancing our DMD program. We expect to have data available this quarter from our HOPE-2 trial and lo...