- 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
Cynata Therapeutics Initiates Patient Treatment in World 1st Clinical Trial
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.
Patient Treatment Commences in Cynata’s World First Clinical Trial (CYP-001)
- First patient with steroid resistant acute graft-versus-host disease (GvHD) treated in Cynata’s phase 1 clinical study of its mesenchymal stem cell (MSC) product, CYP-001
- World first clinical trial using a MSC therapeutic product derived from an induced pluripotent stem cell sourced from a single blood donation from one donor
- Transition into active clinical trials cements Cynata’s world leading position in the development and commercialisation of second generation stem cell products
- Partnership with Fujifilm for the commercialisation of CYP-001; trial commencement accelerates this target
Current Landscape for Stem Cell Clinical Trials
To understand the growing market potential for stem cell therapies, it is critical to consider the current landscape for stem cell clinical trials.
There are 5561 clinical trials found when the term “stem cells” is searched on ClinicalTrials.gov, indicating that there are now thousands of stem cell trials underway worldwide. (Search executed November 7, 2016.)
ClinicalTrials.gov is the global registry of publicly and privately supported clinical studies involving human patients. While not a comprehensive resource, it contains approximately three-quarters of registered cell therapy trials worldwide.
Below is a map showing the location of current stem cell clinical trials.
Map of Stem Cell Clinical Trials, by Geographical Region
“Hotspots” for Stem Cell Clinical Trial Activity
Clearly, North America (3057 trials) and Europe (1288 trials) are “hotspots” for stem cell clinical trial activity.
Among the North American trials, nearly all of them of them are occurring in the United States (2935). [Read more…]
UK Regulatory Authority Approves Cynata Therapeutics’ Phase I GvHD Clinical Trial
- 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
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