Stem cell company prepares for Phase 1 clinical trial

Regenerative medicine company Cynata Therapeutics (ASX:CYP) intends to file an application for regulatory approval with the UK Medicines and Healthcare products Regulatory Agency (MHRA) for a Phase 1 clinical trial of CYP-001, the company’s lead Cymerus mesenchymal stem cell (MSC) product, next month.

The Phase 1 trial will be conducted in patients with steroid-resistant graft-versus-host disease (GvHD). The application process advanced after a successful scientific advice meeting with the MHRA earlier this year.

The company is currently preparing its clinical trial application and expects to receive additional data within the coming weeks from the proof-of-concept (PoC) study of CYP-001 progressing at the University of Massachusetts Amherst, USA. This PoC study is assessing the response to CYP-001 in animals with an experimental form of severe GvHD.

Interim data announced in April demonstrated that CYP-001 treatment resulted in a strong, statistically significant, survival benefit in the study animals and confirmed biological activity of the Cymerus MSC product. The additional data for the MHRA application process is expected to provide a more robust data package for clinical trial approval.

“We are on track with our plans to file the clinical trial application in the UK and with that, the company is approaching a very important, value accretive milestone in the development of Cynata’s unique and proprietary MSC technology, Cymerus,” said Cynata CEO and Managing Director Dr Ross Macdonald.

Earlier this month, it was announced that biopharma industry executive Dr Paul K Wotton had joined the Cynata board of directors. Dr Wotton has more than 30 years’ experience in the pharmaceuticals and biotech industry, having previously served as CEO and president and Ocata Therapeutics from July 2014 until February 2016. Prior to that, he served for six years as CEO and president of Antares Pharma.

“Paul’s direct experience in driving commercial transactions and broad exposure to the stem cell and regenerative medicine sector is particularly pertinent to Cynata’s business model and ongoing partnership discussions,” said Cynata Executive Chairman Dr Stewart Washer. “We look forward to his guidance and to working with Paul as Cynata continues to execute its business strategy.”

“I am delighted to join Cynata at this very exciting time for the company and for regenerative medicine in general, where cell therapy technology is now making important advances,” said Dr Wotton.

“Cymerus addresses a clear industry need for a new-generation MSC manufacturing process that can cost-efficiently produce commercial quantities of premium, clinical-grade MSCs.”

Cynata Therapeutics (ASX:CYP) shares closed 12.28% higher at $0.32 on Tuesday, the day the company announced its MHRA application. They were trading 1.56% lower at $0.315 as of around 11.15 am on Wednesday.