Cynata Therapeutics (ASX:CYP) is progressing towards launching its third phase two clinical trial this year for the treatment of critical limb ischemia (CLI).
In an announcement from CYP, the company has said it received ‘favourable advice’ from the UK’s Medicines and Healthcare products Regulatory Agency.
The advice has confirmed that Cynata’s stem cell manufacturing process and quality control testing was ‘acceptable’ and that its preclinical study results in a model of CLI were also ‘acceptable.’
What this means for CYP is that it paves the way for the Company to soon be able to progress to a phase two clinical trial using its mesenchymal stem cells (MSCs), manufactured by its Cymerus platform, to investigate the treatment of CLI.
What is CLI and how do CYP’s stem cells help?
CLI is an advanced stage of peripheral artery disease (PAD) that is a narrowing of arteries in the limbs.
The narrowing of arteries impairs blood flow which causes pain and tissue damage – with the end result often amputation of the affected limb.
CLI is a significant medical problem with forecast annual global sales forecast to be around US$1.4 billion
Preclinical results showed that administering CYP’s MSCs resulted in the return of blood flow to the affected limb.
The preclinical study used a mouse model of CLI and was conducted at the University of Wisconsin-Madison.
The results compared Cynata’s Cymerus MSC treatment to a media alone control and animals treated with Cynata’s MSCs versus the control showed significantly improved blood flow at every measurement point.
Strong flow of existing data supports phase two trials
Importantly, the MHRA stated that CYP’s biodistribution study was acceptable and requires no other safety studies to support the trial.
CYP says this was likely also supported by the strong results from its graft-versus-host disease (GvHD) phase one clinical trial completed in August last year.
“This confirms Cynata’s understanding that the safety data from the completed Phase 1 trial of Cymerus MSCs in graft versus host disease support direct progression to Phase 2 trials in other indications,” said Dr Kilian Kelly, Cynata’s Vice President, Product Development.
The phase one GvHD trial met all its safety and efficacy end points – 87 percent of patients reported an improvement in severity by at least one grade compared to baseline and 53 percent were reported to have had their symptoms completely resolved.
The CLI trial design was also deemed acceptable by the MHRA and CYP will now progress to the formal trial application.
The study is expected to recruit a total of 90 patients and to commence in the second half of 2019. It will likely involve study centres in the UK and Australia.
Assuming all goes to plan, this will be CYP’s third phase two clinical trial this year.
A proposed clinical trial with the University of Sydney Cynata’s stem cells to treat osteoarthritis is now in the planning phases and its second clinical trial in GvHD is also expected to begin later this year – in collaboration with Fujifilm.
This content is produced by Star Investing in commercial partnership with Cynata Therapeutics. This content does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
Don’t miss a thing, subscribe now