Anyone mention this today U.S. FDA Approves Com
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Posted On: 04/29/2020 9:05:32 PM
Anyone mention this today
U.S. FDA Approves Company’s Expanded Access Protocol to Treat Additional Patients
LOS ANGELES, April 29, 2020 (GLOBE NEWSWIRE) -- Capricor Therapeutics (“Capricor”) (CAPR) a clinical-stage biotechnology company focused on the development of first-in-class biological therapeutics for the treatment and prevention of diseases, announced today new data reporting 100 percent survival in critical COVID-19 patients who were treated with Capricor’s lead asset, off-the-shelf (“allogeneic”) cardiac cell therapy CAP-1002, at Cedars-Sinai Medical Center as part of six compassionate care cases.
Over the course of one month, six critically ill COVID-19 patients, all suffering from acute respiratory distress syndrome (ARDS) and five of whom were on mechanical ventilatory support, were safely treated with CAP-1002. Of the six patients treated, four of them have been discharged. Following a review of the available data, the U.S. Food and Drug Administration (FDA) approved the Company’s expanded access protocol to treat up to 20 additional COVID-19 patients. There is also a randomized, placebo-controlled trial planned to treat patients with moderate and severe disease which is intended to be funded by non-equity capital.
In the compassionate care cases, five male patients and one female patient (between ages 19 and 75) suffering from COVID-19 received IV infusions of 150 million allogeneic cardiosphere-derived cells (CAP-1002). Of the five patients on ventilator support, four patients no longer required ventilator support within just one to four days following the infusion. The fifth patient remains on mechanical ventilation and the sixth patient is receiving supplemental oxygen and is currently clinically stable. Additionally, laboratory biomarkers correlated with poor outcomes were measured in all patients. Following infusion, several patients showed improvements in biomarkers, such as ferritin, absolute lymphocyte counts and CRP. No adverse events related to the administration of CAP-1002 were observed. This data has been submitted for publication.
CAP-1002 demonstrates immunomodulatory properties. Multiple published peer-reviewed studies of CDCs have demonstrated favorable modulation of various inflammatory cytokines and regulation of the immune response. The current understanding of COVID-19’s later stages are thought to be due to overstimulation of the immune system, which triggers a cytokine storm in which the body is overwhelmed with pro-inflammatory molecules. This immune response may become excessive and pathologic, inducing pneumonia, organ failure and death. Therefore, it can be the body's overreaction to COVID-19, rather than the virus itself, that delivers the fatal blow.
"As the global medical community continues to come together in its battle against COVID-19, the results of our initial compassionate care cases are extremely promising and what we had anticipated. We look forward to continuing to treat additional patients under our recently approved expanded access program Investigational New Drug application,” said Dr. Linda Marbán, Ph.D., CEO, Capricor. “CAP-1002 is an easy-to-deliver intravenous therapy that has been administered successfully to over 150 patients to date. Given its novel mechanism of action, it could be a potential game-changer in helping countless COVID-19 patients.”
U.S. FDA Approves Company’s Expanded Access Protocol to Treat Additional Patients
LOS ANGELES, April 29, 2020 (GLOBE NEWSWIRE) -- Capricor Therapeutics (“Capricor”) (CAPR) a clinical-stage biotechnology company focused on the development of first-in-class biological therapeutics for the treatment and prevention of diseases, announced today new data reporting 100 percent survival in critical COVID-19 patients who were treated with Capricor’s lead asset, off-the-shelf (“allogeneic”) cardiac cell therapy CAP-1002, at Cedars-Sinai Medical Center as part of six compassionate care cases.
Over the course of one month, six critically ill COVID-19 patients, all suffering from acute respiratory distress syndrome (ARDS) and five of whom were on mechanical ventilatory support, were safely treated with CAP-1002. Of the six patients treated, four of them have been discharged. Following a review of the available data, the U.S. Food and Drug Administration (FDA) approved the Company’s expanded access protocol to treat up to 20 additional COVID-19 patients. There is also a randomized, placebo-controlled trial planned to treat patients with moderate and severe disease which is intended to be funded by non-equity capital.
In the compassionate care cases, five male patients and one female patient (between ages 19 and 75) suffering from COVID-19 received IV infusions of 150 million allogeneic cardiosphere-derived cells (CAP-1002). Of the five patients on ventilator support, four patients no longer required ventilator support within just one to four days following the infusion. The fifth patient remains on mechanical ventilation and the sixth patient is receiving supplemental oxygen and is currently clinically stable. Additionally, laboratory biomarkers correlated with poor outcomes were measured in all patients. Following infusion, several patients showed improvements in biomarkers, such as ferritin, absolute lymphocyte counts and CRP. No adverse events related to the administration of CAP-1002 were observed. This data has been submitted for publication.
CAP-1002 demonstrates immunomodulatory properties. Multiple published peer-reviewed studies of CDCs have demonstrated favorable modulation of various inflammatory cytokines and regulation of the immune response. The current understanding of COVID-19’s later stages are thought to be due to overstimulation of the immune system, which triggers a cytokine storm in which the body is overwhelmed with pro-inflammatory molecules. This immune response may become excessive and pathologic, inducing pneumonia, organ failure and death. Therefore, it can be the body's overreaction to COVID-19, rather than the virus itself, that delivers the fatal blow.
"As the global medical community continues to come together in its battle against COVID-19, the results of our initial compassionate care cases are extremely promising and what we had anticipated. We look forward to continuing to treat additional patients under our recently approved expanded access program Investigational New Drug application,” said Dr. Linda Marbán, Ph.D., CEO, Capricor. “CAP-1002 is an easy-to-deliver intravenous therapy that has been administered successfully to over 150 patients to date. Given its novel mechanism of action, it could be a potential game-changer in helping countless COVID-19 patients.”
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