U.S. FDA Approves Company’s Expanded Access Protocol to Treat Additional Patients
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.
https://finance.yahoo.com/news/capricor-data-reports-100-percent-131510422.html
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