Proposed stem cell trial on track for approval
Cynata Therapeutics (ASX:CYP) yesterday announced that it had received favourable advice from the UK Medicines and Healthcare products Regulatory Agency (MHRA), causing shares in the regenerative medicine company to jump by over 20%.
The MHRA confirmed that Cynata’s Cymerus mesenchymal stem cell (MSC) product, CYP-001, is considered to be suitable for use in a proposed Phase 1 clinical trial in patients with graft versus host disease. The Cymerus platform provides a source of MSCs that is independent of donor limitations and provides a potential ‘off-the-shelf’ stem cell platform for therapeutic product use.
The agency additionally advised that Cynata’s existing program of preclinical studies should be sufficient to support the approval of the proposed trial; that no additional preclinical studies are required; and that the general design of the proposed trial was agreeable.
“We are delighted that one of the world’s most respected and experienced regulatory authorities has provided such a favourable assessment of the Cymerus technology,” said Dr Kilian Kelly, Cynata’s vice president, product development. “This reinforces the view that we had formed previously — that regulators in key jurisdictions are comfortable in principle with the progression of iPSC-derived therapies into human clinical trials.”
On the basis of the advice, Cynata intends to conduct the clinical trial at centres in the European Union, including the United Kingdom, and Australia. Additional countries in the EU will be confirmed following the completion of further interactions with the relevant regulatory authorities in those jurisdictions.
“We look forward to confirming the participating sites and proceeding with clinical trial applications (CTA) for this groundbreaking clinical trial in the near future,” Dr Kelly said. The company expects to formally select the centres by the end of the first quarter, with the trial to commence during the second quarter.
Cynata Therapeutics (ASX:CYP) shares finished 23.33% higher at $0.37 as of the close of trading on Thursday.
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