Cynata's Technology Significant Efficacy In Preclinical Asthma Study

• Data suggests Cynata’s unique Cymerus™ iPSC-generated MSCs may have potential clinical use as a treatment for asthma

• Intranasal administration of Cymerus™ MSCs completely normalised airway hyperresponsiveness in a mouse model of asthma

Melbourne, Australia; 17 October 2016: Australian stem cell and regenerative medicine company, Cynata Therapeutics Limited (ASX: CYP), announced today that it has received compelling data from a proof of concept study of its Cymerus™ mesenchymal stem cells (MSCs) in an experimental model of asthma.

Asthma is a chronic, long term lung condition that impacts over 330 million people globally.¹ Cynata, through its partnership with Monash University has been investigating the use of its Cymerus™ technology as a potential alternate treatment for asthma sufferers.

In this study, conducted under the supervision of Associate Professor Chrishan Samuel and Dr Simon Royce at Monash University, in the Department of Pharmacology and the Monash Biomedicine Discovery Institute, Melbourne, the well-established chronic allergic airways disease model was induced by sensitising and challenging mice with a protein called ovalbumin. The features of this model closely resemble the clinical manifestations of asthma in humans.

As expected, subjecting mice to the ovalbumin sensitisation regime caused them to exhibit significantly increased airway hyper-responsiveness (AHR; p<0.001 vs saline-treated control group), which is the key characteristic of asthma. Intravenous administration of Cynata’s MSCs in these animals caused a statistically significant (60-70%) decrease in AHR (p<0.01) relative to untreated sensitised animals. Moreover, intranasal administration of Cynata’s MSCs completely normalised AHR, to a level that was no longer different to healthy animals, in which the asthma model had not been induced. No adverse safety findings were observed during the study.

“We are very excited by these results, which indicate that Cymerus™ MSCs could have a profound effect in the treatment of asthma. This is a debilitating condition, which affects about 10% of the population, resulting in close to 40,000 hospitalisations and several hundred deaths each year, in Australia alone”,² said Cynata Vice President of Product Development, Dr Kilian Kelly. “Although a number of drugs are approved for the treatment of asthma, studies have shown that conventional treatments result in as few as 5% of asthma patients achieving full control of their condition.³ Consequently, there is a widely recognised need for novel treatments that address – and potentially eliminate – the underlying disease”, added Dr Kelly.

“This study has clearly demonstrated that Cynata’s MSCs have a dramatic effect on AHR in our model, particularly when directly administered into the allergic lung. We look forward to continuing our analysis of the effects of these unique cells on markers of inflammation and airway remodelling, and we are optimistic of building on the very positive data we have generated so far”, said Associate Professor Samuel.

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