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Highlights
- Cynata reports Australian Ethics Committee approval for proposed Phase 2 clinical trial in aGvHD
- Cynata previously announced Institutional Review Board approval in the USA and received green light from the US FDA for an Investigational New Drug application
- The company also holds the Orphan Drug Status in the US for CYP-001, its lead product candidate
- Dr Jolanta Airey, Cynata’s Chief Medical Officer, says that patient recruitment for aGvHD clinical trial (Phase 2) would begin this quarter
Cynata Therapeutics (ASX: CYP) – ASX-listed Australian company working in the stem cell and regenerative medicine space -- has been granted Australian ethics committee approval to start the proposed aGvHD clinical trial (Phase 2). The company has previously announced that the trial would be conducted in patients in Australia as well as in the US and Europe.
Source: CYP ASX announcement dated 12 April 2023
In a separate development, the company had last week informed about fund raising of ~AU$7 million. Read more.
Share price jumps over 2%
Cynata's ASX-listed shares were spotted trading at AU$0.230 in the early hours on 12 April 2023, up more than 2% from the last close. The company has a market cap of over AU$32 million.
The development - Ethics Committee approval
The cell therapeutics specialist company can now begin with the acute graft-versus-host disease (aGvHD) Phase 2 trial of lead product CYP-001. Cynata has stated that the approval by the Ethics Committee is a crucial step with respect to opening the clinical study sites and starting human trials in the country.
The Australian company has also stated it is presently "finalising contractual and logistic arrangements" with hospitals in preparation for the recruitment of patients. Notably, the Ethics Committee green light follows other significant US milestones like the FDA nod of the 2022 IND application, the Orphan Drug Status, and the Institutional Review Board approval.
The proposed aGvHD Phase 2 trial is expected to be undertaken in around 60 patients in Australia as well as in the US and Europe. The company's Chief Medical Officer has commented that recruitment is expected to commence this quarter, while the primary evaluation of the trial data would likely be done next year.
About Cynata Therapeutics
The Australian cell therapeutics company is working primarily on the proprietary Cymerus™ platform. This technology can help in efficient manufacturing of cell therapy products that include mesenchymal stem cells. CYP-001 is the company's lead candidate. It has shown encouraging safety and efficacy data in the Phase 1 aGvHD trial. Now, the Phase 2 trial is set to commence after the grant of approvals by the FDA and the Australian Human Research Ethics Committee.
