Cynata Release: Final Preclinical Asthma Study Confirms Efficacy

• Clear confirmation of efficacy of Cynata’s proprietary Cymerus™ MSCs in second preclinical asthma study
• Treatment with Cymerus MSCs in clinically-relevant model caused significantly greater reduction of airway hyperresponsiveness, airway remodelling and fibrosis compared to corticosteroid treatment
• Combination therapy involving Cymerus MSCs and corticosteroids resulted in a pronounced synergistic effect, producing marked anti-inflammatory effects in addition to the benefits seen with Cymerus MSC treatment alone
• Strong efficacy data from this trial advances path towards clinical trials in asthma, a disease that impacts +300 million people globally[i]

Melbourne, Australia; 11 December 2017: Australian stem cell and regenerative medicine company, Cynata Therapeutics (ASX: CYP), is pleased to announce that it has received the final report on the effects of Cymerus MSCs in combination with or in comparison to the corticosteroid dexamethasone in a further preclinical asthma study. Corticosteroids are considered to be the most effective medications for controlling asthma (when taken regularly).

The study was conducted under the supervision of Associate Professor Chrishan Samuel and Dr Simon Royce of the Monash Lung Biology Network,[ii] using a well-established mouse model of chronic allergic airways disease, which closely resembles asthma in humans, and includes several key features: airway inflammation; airway remodelling/fibrosis (structural changes in the airways due to excess fibrous tissue); and airway hyperresponsiveness.

Daily administration of dexamethasone (a corticosteroid), demonstrated marked anti-inflammatory effects in this model. It reduced airway inflammation by approximately 55% and airway inflammation-induced goblet cell metaplasia (abnormal changes in the cells responsible for producing mucus) by approximately 80% (both p<0.001 vs untreated mice). However, dexamethasone displayed weak anti-remodelling and anti-fibrotic effects, and only reduced airway hyperresponsiveness by approximately 30% over the 2 week-treatment period.

In comparison, once-weekly administration of one million Cymerus MSCs resulted in striking reductions of airway remodelling, fibrosis and airway hyperresponsiveness. Most notably, subepithelial collagen deposition (a measure of fibrosis) and airway TGF-β1 expression levels (a measure of airway remodelling) were normalised to levels equivalent to mice in which asthma had not been induced, while airway hyperresponsiveness was reduced by 70-75% (all p<0.001 vs untreated mice).

When the two treatments were combined, a pronounced synergistic effect was achieved, resulting in similar anti-inflammatory effects to dexamethasone alone and similar reductions in remodelling, fibrosis and airway hyperresponsiveness to Cymerus MSCs alone.

Summary of Results

“The combination of Cymerus MSCs and dexamethasone resulted in maximal improvement for each endpoint measured. Hence, it can be concluded that such a combination therapy has the potential to improve treatment outcomes in asthmatic patients,” said Associate Professor Samuel.

Dr Kilian Kelly, Cynata’s Vice President, Product Development commented: “These findings further strengthen the body of evidence supporting the use of Cymerus MSCs as a potential asthma treatment. In addition to confirming that Cymerus MSCs had a greater effect than corticosteroid treatment on several key manifestations of asthma in this model, these results provide clear evidence that Cymerus MSCs can work in synergy with corticosteroids. Overall, the results suggest that Cymerus MSCs could be used as a standalone treatment, for example in patients who are unable to tolerate corticosteroids, or as an add-on therapy in patients who are unable to gain control of their condition with existing medications.”