Athersys and Cell Therapy Catapult announce grant to support Clinical Development of Stem Cell Therapy for Severe Acute Respiratory Condition

Athersys Limited (an affiliate of Athersys, Inc.) (Nasdaq:ATHX) and the Cell Therapy Catapult, a not-for-profit centre, which is focused on the development of the United Kingdom cell therapy industry to increase the nation’s health and wealth, are pleased to announce that Athersys Limited has been awarded a grant from Innovate UK, formerly the Technology Strategy Board, which will support a Phase 2a clinical study evaluating the administration of MultiStem® cell therapy to acute respiratory distress syndrome (ARDS) patients.

The grant is expected to provide up to approximately £2.0 million in support over the course of the study, which will be conducted by Athersys Limited at leading clinical sites in the UK in conjunction with the Cell Therapy Catapult.

“We are pleased to receive this award from Innovate UK and to work with the Cell Therapy Catapult to conduct this important study. Both organizations reflect a commitment to be a driving force in healthcare innovation, and to establish the UK as the leading gateway for the regenerative medicine field in Europe,” said Dr. Gil Van Bokkelen, Chairman and CEO of Athersys, Inc. “ARDS is a serious condition that is ineffectively treated by current standards of care, resulting in substantial patient and healthcare system impact. We believe that MultiStem cell therapy may provide an important new option for treatment, and has the potential to meaningfully improve clinical outcomes for patients that are extremely ill.”

Keith Thompson, CEO of the Cell Therapy Catapult said, “We are excited by the potential health benefits this trial may achieve for such severe and life-threatening disease, such as ARDS. Bringing advanced therapeutic clinical trials to the UK is a key part of our strategy to accelerate the growth of the cell therapy industry to generate health and wealth. We are delighted to collaborate with Athersys Limited on this important trial.”

ARDS is a serious immunological and inflammatory condition characterised by widespread inflammation in the lungs. ARDS can be triggered by pneumonia, sepsis, or other trauma and represents a major cause of morbidity and mortality in the critical care setting. It has significant implications, as it prolongs intensive care unit (ICU) and hospital stays, and requires convalescence in the hospital and rehabilitation. There are limited interventions and no effective drug treatments for ARDS, making it an area of high unmet clinical need with high treatment costs. Given ARDS high treatment costs, a successful cell therapy could be expected to generate significant savings for the healthcare system by reducing days on a ventilator, days in the ICU and total days in the hospital, and importantly, could reduce mortality and improve quality of life for those suffering from the condition. The medical need for a safe and effective treatment of ARDS is significant due to its high mortality rate, and it affects annually approximately 33,000 patients in the UK and 400,000 – 500,000 patients in Europe, the United States and Japan, alone.

MultiStem cell therapy has demonstrated the capacity to reduce inflammation, support tissue regeneration and promote homeostasis in acute immunological and injury settings. Preclinical data suggests that MultiStem cells may have a protective effect by shifting the physiological response from pro-inflammatory to anti-inflammatory. In animal models, MultiStem cells have demonstrated an ability to reduce the severity of pulmonary distress, reduce alveolar edema and return lung endothelial permeablity to normal. Intravenous MultiStem treatment early following the onset of the condition may ameliorate the initial hyper-inflammation and reduce the fibrotic activity that follows, thereby speeding the return to and improving the likelihood of more normal lung function, and helping patient recovery.