- Patient dosing commenced in world-first Phase I trial of stem cell therapy CYP-001 in graft-versus-host disease; recruiting at six centres in the UK and Australia
- Secured $60-million-plus FUJIFILM partnership and license option for CYP-001 in GvHD
- Raised additional $10 million: $4 million equity investment from FUJIFILM and $6 million placement
- Reported positive pre-clinical data in heart attack and asthma; expanded pre-clinical pipeline to acute respiratory distress syndrome
- Filed two new patent applications with IP Australia to expand opportunities in cancer immunotherapy
- Completed pre-Investigational New Drug meeting with U.S. Food and Drug Administration Office of Cellular, Tissue and Gene Therapy; written recommendation expected by July 2017
In breaking news released earlier this month, Cynata Therapeutics (ASX: CYP) announced a major world first. The company treated a patient with steroid resistant acute graft-versus-host disease (GvHD) as part of a phase 1 clinical study of its first mesenchymal stem cell (MSC) product, CYP-001 .
This is an important value catalyst for Cynata and also for the regenerative medicine industry, because it is the first time ever that a patient has been treated with an allogeneic induced pluripotent stem cell (iPSC)-derived therapeutic mesenchymal stem cell (MSC) product.
Robust survival benefit resulting from treatment with CYP-001 confirmed
Substantial body of data generated to support mechanism of action of CYP-001 in GvHD
Melbourne, Australia; 6 February 2017 — Australian stem cell and regenerative medicine company, Cynata Therapeutics Limited (ASX: CYP), announced today that it has received a final report of the proof of concept study of its lead CymerusTM mesenchymal stem cell (MSC) product for graft-versus-host disease (GvHD), CYP-001, in a humanised mouse model of GvHD, which was conducted under the supervision of Associate Professor Lisa Minter at the University of Massachusetts Amherst (UMass), USA. [Read more…]
- UK regulatory authority MHRA approves Phase 1 trial with Cymerus(TM) MSCs
- World first clinical trial with allogeneic iPSC-derived product
- Major milestone for stem cell therapeutics and regenerative medicine
- Cements Cynata’s global leadership in second generation MSC therapeutics