January 31, 2021, Melbourne: CSL Behring Australia, a subsidiary of CSL Limited, today announced that recruitment will commence for a clinical trial of an anti-SARS-CoV-2 plasma product with the potential to treat people with serious complications of COVID-19.
The investigational product, known as CSL760, has been developed using donations of plasma from people who have recovered from COVID-19 and collected by the Australian Red Cross Lifeblood.These donors have high levels of antibodies (proteins that fight COVID-19) in their plasma (the liquid part of their blood), and these antibodies are pooled, purified and concentrated to make a COVID-19 hyperimmune globulin.
In preparation for the trial, the investigational product has been manufactured by CSL Behring Australia at its advanced manufacturing facility located in Broadmeadows, Victoria.
The Australian study aims to enroll 24 male or female healthy volunteers, aged between 18 and 65 years. The trial involves a screening period to determine eligibility followed by a four night stay in a Clinical Pharmacology Unit during which time a single intravenous infusion of CSL760 will be administered at one of two dose levels. The remainder of the study will be a safety follow up period for a duration of approximately four months.
The trial will be conducted in Adelaide, South Australia by CMAX; an independent Phase one and two clinical trials unit. Volunteers interested in participating in the trial can visit www.cmax.com.au for further information.
Dr Andrew Nash, Senior Vice President, Head of Research and Chief Scientific Officer, CSL Limited said, “Unlike a COVID-19 vaccine, Hyperimmunes are not a novel product. CSL Behring already manufactures several hyperimmunes under contract to the Australia Commonwealth Government. These include hyperimmunes to treat diseases such as hepatitis B and tetanus.
These hyperimmunes are manufactured using plasma collected from Australia’s donors and have a strong track record for safety.”
Within this context, the safety and efficacy of COVID-19 Immunoglobulin will need to be demonstrated during clinical trials before it can be registered for routine manufacture and supply in Australia.
Data from the trial will be used to recommend a dosage and will be supplemented by data collected through the global CoVIg-19 Plasma Alliance program, an unprecedented alliance of the world’s leading plasma companies that CSL Behring co-founded at the start of the pandemic, to support the product registration process in Australia.
Dr Nash added, “We hope data from this trial will further support the development of a treatment to prevent Australia’s patients from serious complications related to COVID-19.”
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Note to Editors: Development of a COVID-19 Immunoglobulin from plasma donated in Australia is one of many approaches CSL is exploring to help combat the COVID-19 global pandemic. CSL is part of a previously announced world-leading global alliance formed with other companies that manufacture plasma products. The global alliance is also focused on developing and delivering a COVID-19 immunoglobulin product. The Australian-based project will take advantage of all possible synergies with the global Alliance project as well as contribute any resulting data from the Australian clinical study to the international effort.
About CSL Behring: CSL Behring is a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients’ needs by using the latest technologies, we develop and deliver innovative therapies that are used to treat coagulation disorders, primary immune deficiencies, hereditary angioedema, respiratory disease, and neurological disorders. The company’s products are also used in cardiac surgery, burn treatment and to prevent hemolytic disease of the newborn.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. The parent company, CSL Limited (ASX:CSL;USOTC:CSLLY), headquartered in Melbourne, Australia, employs more than 25,000 people, and delivers its life-saving therapies to people in more than 100 countries. For inspiring stories about the promise of biotechnology, visit Vita CSLBehring.com/vita and follow us on Twitter.com/CSLBehring