Capricor Initiates Compassionate Use Program for Severe COVID-19 Patients using CAP-1002, its Novel Cell Therapy.
LOS ANGELES, April 03, 2020 — 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, 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 look forward to sharing those results,” said Dr. Marbán.
About CAP-1002
CAP-1002 consists of allogeneic cardiosphere-derived cells, or CDCs, a type of cardiac cell therapy that has been shown in pre-clinical and clinical studies to exert potent immunomodulatory activity and is being investigated for its potential to modify the immune system’s activity to encourage cellular regeneration. The cells function by releasing exosomes that are taken up largely by macrophages and T-cells and begin a cycle of repair. CDCs have been the subject of over 100 peer-reviewed scientific publications and have been administered to over 150 human subjects across several clinical trials.
About Capricor Therapeutics
Capricor Therapeutics, Inc. (NASDAQ: CAPR) is a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class biological therapeutics for the treatment or prevention of serious diseases. Capricor’s lead candidate, CAP-1002, is an allogeneic cell therapy that is currently in clinical development for the treatment of Duchenne muscular dystrophy. Capricor is also investigating the field of extracellular vesicles and is exploring the potential of exosome-based candidates to treat or prevent a variety of disorders. For more information, visit www.capricor.com.
CAP-1002 is an Investigational New Drug and is not approved for any indications. None of Capricor’s exosome-based candidates have been approved for clinical investigation.
To learn more, view the report “COVID-19 Global Market Conditions: Pipelines for Diagnostics, Treatments, Cell Therapies & Vaccines.”
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