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Cynata applies for clinical trial testing CLI treatment

Health Care
ASX:CYP      MCAP $43.11M
25 November 2019 17:30 (AEST)

Cynata, a medical technology company specialising in stem cell treatments, has applied to conduct a phase two clinical trial of its trademark Cymerus products.

The Cymerus product CYP-002 will be tested during the trial. CYP-002 treats critical limb ischaemia (CLI) – a condition which obstructs arteries causing severely reduced blood flow, predominately to the legs.

CLI can often lead to amputations of affected body parts and poses a serious risk of causing cardiovascular disease. The condition is an advanced stage of peripheral artery disease (PAD) which was labelled a “global pandemic of growing proportions” in the journal Endovascular Today, earlier this year.

Up to 202 million people suffer from varying degrees of PAD worldwide, making it one of the most common diseases. Cynata expects the global treatment market for CLI to reach $5.4 billion by 2025.

Discussing the impact of CLI, Cynata’s Chief Operating Officer, Dr Kilian Kelly, said it “is an extremely serious condition and existing therapies have limited success.”

“We are optimistic that CYP-002 may offer a valuable new treatment option,” Dr Kilian continued.

The clinical trial application was submitted to the UK Medicines and Healthcare products Regulatory Agency (MHRA), it is likely the review process will take 60 days. The company plans to conduct the trial across a number of centres in the U.K. and Australia.

“We look forward to the MHRA’s review of this important trial, and we aim to commence the recruitment of patients early in the coming year,” she added.

Preclinical trials on mice showed the company’s product led to “significantly higher blood flow in the ischaemic limb versus placebo where blood flow remained low and resulted in limb loss,” the company’s release to the market today detailed.

As market close approaches, Cynata’s share price has fallen 2.5 per cent into the red. In early trade share’s in the company rose by three cents, however, began declining around 1:30 pm AEDT. Shares in the company are currently trading for $1.16 each.

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