Grifols begins clinical trial of a new treatment that would provide immediate immunity against COVID-19
Grifols has announced a clinical trial set to commence in February 2021 in Spain to evaluate the safety and efficacy of a new COVID-19 treatment utilizing Gamunex®-C, which contains anti-SARS-CoV-2 polyclonal antibodies from recovered plasma donors. The trial will involve approximately 800 asymptomatic patients testing positive for the virus. This treatment is designed to offer immediate post-exposure protection, particularly for vulnerable populations. Results are anticipated in Spring 2021, with the potential to enhance existing vaccination efforts.
- Launch of a clinical trial for a new COVID-19 treatment using Gamunex®-C.
- Approximately 800 patients will participate, indicating significant research investment.
- Potential to provide immediate protection against COVID-19, especially for vulnerable groups.
- No reported financial metrics or commitments related to the trial's funding or economic impact.
- Success of the treatment is uncertain until trial results are available in Spring 2021.
BARCELONA, Spain, Jan. 18, 2021 /PRNewswire/ -- Grifols (MCE: GRF, MCE: GRF.P, NASDAQ: GRFS), a global leader in the development of therapies with plasma-derived proteins with a track record of more than 100 years dedicated to enhancing people's health and well-being, today announced it will begin a clinical trial in Spain to evaluate the safety and efficacy of a new COVID-19 drug based on the Grifols immunoglobulin Gamunex®-C and containing anti-SARS-CoV-2 polyclonal antibodies from plasma donors who have recovered from the disease.
The new drug would provide immediate post-exposure protection against the virus and would be especially useful as a complement to the vaccine in the early phase after vaccination. In addition, it could protect the elderly and healthcare workers as well as immunocompromised patients for whom vaccination isn't recommended. It could also help contain outbreaks in places where the vaccination hasn't begun or is still underway.
Grifols expects this clinical trial, led by the researchers Oriol Mitjà and Bonaventura Clotet, from Germans Trias i Pujol Hospital in Barcelona, to begin in February 2021, with the possibility of results in the spring.
About 800 patients, all asymptomatic but having tested positive for the virus in a diagnostic test, will participate in the clinical study, receiving subcutaneously Grifols' immunoglobulin rich with anti-SARS-CoV-2 antibodies.
The Grifols immunoglobulin Gamunex®-C, whether administered intravenously, intramuscularly or subcutaneously, has proven to be safe and efficacious in the prevention of diverse infectious diseases in immunocompromised patients and has been used for this for more than 15 years.
According to Dr. Mitjà, "This treatment based on immunoglobulins would provide a combination of polyclonal antibodies that, compared with monoclonal antibodies, offers a greater diversity that could improve the degree of protection against the virus."
Dr. Antonio Páez, Medical Director at Grifols, underscores that the potential treatment "is easy to refrigerate while its subcutaneous administration facilitates its distribution and use in any doctor's office, avoiding hospitalization. If the new therapy's efficacy is confirmed, it could be administered to people who test positive for the virus through PCR and antigen tests in hospitals and primary care offices."
Grifols, a global leader in the production and distribution of immunoglobulins and hyperimmune immunoglobulins, currently has underway more than 25 research initiatives to treat different stages of COVID-19, from early exposure to the virus to severe cases requiring hospitalization and intensive care.
In October 2020, Grifols, together with other companies and various U.S. health agencies, began the clinical trial ITAC (Inpatient Treatment with Anti-Coronavirus Immunoglobulin) to evaluate the efficacy and safety of the anti-SARS-CoV-2 hyperimmune globulin in hospitalized and serious cases. Results are expected during the first half of 2021.
About Grifols
Grifols is a global healthcare company that since its founding in Barcelona in 1909 has enhanced the health and well-being of people around the world. Its four divisions – Bioscience, Diagnostic, Hospital and Bio Supplies – develop, produce and market innovative solutions and services in more than 100 countries.
As pioneers in the plasma industry, Grifols is one of the largest plasma companies, with a growing network of donation centers worldwide. It develops this plasma into essential medicines used to treat chronic, rare and, at times, life-threatening conditions. As a recognized leader in transfusion medicine, Grifols also offers a comprehensive portfolio of solutions designed to enhance safety from donation through transfusion. And the company supplies tools, information and services that enable hospitals, pharmacies and healthcare professionals to efficiently deliver expert medical care.
Grifols, with more than 24,000 employees in 30 countries and regions, is committed to a sustainable business model that sets the standard for continuous innovation, quality, safety and ethical leadership in the industry.
In 2019, Grifols' economic impact in its core countries of operation was 8.5 billion euros. The company also generated 148,000 jobs, including indirect and induced.
The company's class A shares are listed on the Spanish Stock Exchange, where they are part of the Ibex-35 (MCE:GRF). Grifols non-voting class B shares are listed on the Mercado Continuo (MCE:GRF.P) and on the U.S. NASDAQ through ADRs (NASDAQ:GRFS).
For more information, please visit www.grifols.com
LEGAL DISCLAIMER
The facts and figures contained in this report that do not refer to historical data are "future projections and assumptions". Words and expressions such as "believe", "hope", "anticipate", "predict", "expect", "intend", "should", "will seek to achieve", "it is estimated", "future" and similar expressions, in so far as they relate to the Grifols group, are used to identify future projections and assumptions. These expressions reflect the assumptions, hypotheses, expectations and predictions of the management team at the time of writing this report, and these are subject to a number of factors that mean that the actual results may be materially different. The future results of the Grifols group could be affected by events relating to its own activities, such as a shortage of supplies of raw materials for the manufacture of its products, the appearance of competitor products on the market, or changes to the regulatory framework of the markets in which it operates, among others. At the date of compiling this report, the Grifols group has adopted the necessary measures to mitigate the potential impact of these events. Grifols, S.A. does not accept any obligation to publicly report, revise or update future projections or assumptions to adapt them to events or circumstances subsequent to the date of writing this report, except where expressly required by the applicable legislation. This document does not constitute an offer or invitation to buy or subscribe shares in accordance with the provisions of the following Spanish legislation: Royal Legislative Decree 4/2015, of 23 October, approving recast text of Securities Market Law; Royal Decree Law 5/2005, of 11 March and/or Royal Decree 1310/2005, of 4 November, and any regulations developing this legislation. In addition, this document does not constitute an offer of purchase, sale or exchange, or a request for an offer of purchase, sale or exchange of securities, or a request for any vote or approval in any other jurisdiction. The information included in this document has not been verified nor reviewed by the external auditors of the Grifols group.
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