Cerus Corporation Reports Successful Inactivation of SARS-CoV-2 with the INTERCEPT Blood System for Plasma
July 07 2020 - 8:30AM
Business Wire
Cerus Corporation (Nasdaq:CERS) announced today study results
demonstrating that the INTERCEPT Blood System inactivates
SARS-CoV-2, the causative agent for COVID-19, in plasma components
intended for transfusion. These data are consistent with prior
INTERCEPT studies showing complete inactivation, to below the limit
of detection, of other coronaviruses associated with severe
pulmonary disease: MERS-CoV1,2 (2018, 2019) and SARS-CoV-13
(2005).
The in vitro study evaluated inactivation of SARS-CoV-2 in
plasma components using both infection and molecular assays, as
well as cell culture passaging experiments, allowing the
confirmation of complete inactivation over time. Under the
Principal Investigators Prof. Esam Ibraheem Azhar (Special
Infectious Agents Unit - BSL3, King Fahd Medical Research Center,
King Abdulaziz University, Jeddah, Saudi Arabia) and Prof. Salwa
Hindawi (Department of Hematology, Faculty of Medicine), the study
was conducted at the Special Infectious Agents Unit - BSL3, King
Fahd Medical Research Center, King Abdulaziz University, Jeddah,
Saudi Arabia, with a local clinical SARS-CoV-2 isolate. This center
is known for its expertise in coronavirus research. A manuscript
for publication is currently in preparation. The investigators are
currently conducting a subsequent study to assess the ability of
the INTERCEPT Blood System to inactivate SARS-CoV-2 in platelet
components. These studies are funded by the Saudi Arabia Ministry
of Health and supported by Cerus.
“Given the ongoing global COVID-19 pandemic, these study results
are significant in showing efficacy against a highly pathogenic
coronavirus,” said Dr. Richard Benjamin, Cerus’ chief medical
officer. “While no transfusion transmitted SARS-CoV-2 infections
have been reported to date, viral RNA has been observed in the
plasma of some patients; and the inactivation data from this study
indicate that the INTERCEPT Blood System could reduce the potential
risk of SARS-CoV-2 transmission by transfusion of convalescent
plasma from recovered COVID-19 patients.”
Separately, Cerus is conducting a set of in vitro studies in the
United States to assess the INTERCEPT Blood System’s ability to
inactivate SARS-CoV-2 in red blood cells, as well as platelets and
plasma. These studies are funded by the Biomedical Advanced
Research and Development Authority (BARDA) as part of Cerus’ recent
contract amendment and associated funding increase.
BARDA is part of the Office of the Assistant Secretary for
Preparedness and Response within the U.S. Department of Health and
Human Services. The development of the INTERCEPT red blood cell
program has been funded in whole or in part with federal funds from
the Department of Health and Human Services; Office of the
Assistant Secretary for Preparedness and Response; Biomedical
Advanced Research and Development Authority, under Contract No.
HHSO100201600009C.
The INTERCEPT Blood Systems for platelets, plasma, and red cells
plasma are proactive interventions designed to inactivate a broad
spectrum of viruses, bacteria, protozoa, and contaminating donor
leukocytes in plasma components to reduce the risk of transfusion
transmitted infections especially in pandemics of emerging
pathogens before donor testing is available.
- Hindawi, S. I., A. M. Hashem, et al. (2018). "Inactivation of
Middle East respiratory syndrome-coronavirus in human plasma using
amotosalen and ultraviolet A light." Transfusion 58(1): 52-59.
- Hashem, A. M., A. M. Hassan, et al. (2019). "Amotosalen and
ultraviolet A light efficiently inactivate MERS-coronavirus in
human platelet concentrates." Transfusion
Medicine 29 (6): 434-441.
- Pinna, D., A. Sampson-Johannes, et al. (2005). "Amotosalen
photochemical inactivation of severe acute respiratory syndrome
corona virus (SARS-CoV) in human platelet concentrates."
Transfusion Medicine 15:
269-276.
ABOUT SPECIAL INFECTIOUS AGENTS UNIT –BSL3
The unit was established in late 2003 at King Fahd Medical
Research Center, King Abdulaziz University with the aim of
performing research projects and diagnostic assays for a wide range
of infectious agents (Bacterial, Viral, Fungal, and Parasites). The
unit is equipped with state-of-the-art technologies that allow to
provide epidemic aid and conducts epidemiologic studies on the
detection, prevention, and control of highly hazardous viral
diseases. The unit provides primary isolation, identification, and
characterization of highly hazardous disease agents that require
biosafety level 3 laboratory conditions for their safe handling;
develops, evaluates, and improves methods for treatment,
prevention, and laboratory diagnosis of hazardous disease agents.
The unit also conducts laboratory, clinical, and epidemiological
investigations on the pathogenesis, pathophysiology, and prevention
of viral infections caused by risk group 3 viruses; develops and
evaluates education programs for educating health professionals
about infection, prevention and laboratory diagnosis of infectious
diseases.
ABOUT CERUS
Cerus Corporation is dedicated solely to safeguarding the
world’s blood supply and aims to become the preeminent global blood
products company. Based in Concord, California, our employees are
dedicated to deploying and supplying vital technologies and
pathogen-protected blood components for blood centers, hospitals
and ultimately patients who rely on safe blood. With the INTERCEPT
Blood System, we are focused on protecting patients by delivering
the full complement of reliable products and expertise for
transfusion medicine. Cerus develops and markets the INTERCEPT
Blood System and remains the only company in the blood transfusion
space to earn both CE Mark and FDA approval for pathogen reduction
of both platelet and plasma components. Cerus currently markets and
sells the INTERCEPT Blood System in the United States, Europe, the
Commonwealth of Independent States, the Middle East and selected
countries in other regions around the world. The INTERCEPT Red
Blood Cell system is in clinical development. For more information
about Cerus, visit www.cerus.com and follow us on LinkedIn.
INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus
Corporation.
Forward Looking Statements
Except for the historical statements contained herein, this
press release contains forward-looking statements concerning the
potential reduction in the risk of transmission of SARS-CoV-2 as a
result of the transfusion of convalescent plasma for COVID-19
patients, and other statements that are not historical facts.
Actual results could differ materially from these forward-looking
statements as a result of certain factors, including, without
limitation, risk that further studies may indicate that the
INTERCEPT Blood System does not successfully inactivate SARS-CoV-2;
that applicable regulatory authorities may disagree with Cerus‘
interpretations of the data from the in vitro studies; as well as
other risks detailed in Cerus’ filings with the Securities and
Exchange Commission, including Cerus’ Quarterly Report on Form 10-Q
for the quarter ended March 31, 2020, filed with the SEC on May 5,
2020. In addition, to the extent that the COVID-19 pandemic
adversely affects Cerus’ business and financial results, it may
also have the effect of heightening many of the other risks and
uncertainties described above. Cerus disclaims any obligation or
undertaking to update or revise any forward-looking statements
contained in this press release.
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Tim Lee – Investor Relations Director Cerus Corporation
925-288-6137
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