In pre-clinical studies led and published by Professor John Laffey at NUI Galway ORBCEL demonstrated the ability to mitigate the effects of pneumonia induced ARDS by improving lung oxygenation, reducing inflammation, reducing oedema and decreasing bacterial infection.
This trial of its second-generation immunotherapy, ORBCEL, follows the recent successful completion of a phase 1 trial in 2019 in patients with moderate-severe ARDS. The phase 2a trial, funded by the Wellcome Trust, has been approved by the UK’s Medical Health Regulatory Agency (MHRA) and REALIST has been identified by the UK National Institute for Health Research (NIHR) as a National Urgent Public Health study.
Professors Danny McAuley and Cecilia O’Kane at the UK’s Queen’s University Belfast, are leaders in the development and delivery of new medicines for critical care and ARDS and lead the trial which will includes five clinical sites in the United Kingdom.
A recent statement from the four UK Chief Medical Officers outlined the importance of clinical trials amidst the COVID-19 crisis. Professor Cecilia O’Kane – who leads the REALIST program highlighted:e “It is only through clinical trials will we be able to determine if new treatments are effective and safe in critically ill patients.”
“The successful completion of ORBCEL’s phase 1 clinical trial confirms our belief in the potential of Orbsen's proprietary stromal cell immunotherapy technologies,” said Dr Larry Couture, CEO of Orbsen Therapeutics. “We believe ORBCEL will prove a valuable addition to the arsenal of therapies to combat the effects of COVID-19.”