Dear Cynata Supporter,
I am delighted to share with you today’s announcement regarding the clearance of our IND by the US FDA. A copy of our ASX release is attached for your convenience.
The IND clearance means Cynata may now commence a Phase 2 clinical study in aGvHD in the US, subsequent to the customary and satisfactory completion of negotiations with study centres and receipt of relevant ethics and administrative approvals.
This hugely important achievement marks a significant advancement of our proprietary Cymerus™ mesenchymal stem cell (MSC)platform.
The validation of our information package, which includes comprehensive clinical, preclinical, manufacturing and quality control data on our product and the underlying iPSC-derived manufacturing platform, is a key valuation catalyst.
I look forward to bringing you further updates around the planned Phase 2 clinical trial in acute graft-versus-host disease (GvHD).
Yours sincerely
Ross Macdonald
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