Although there are key players in markets like the U.S., Australia, and the EU, Japan continues to accelerates its position as a hub for induced pluripotent stem cell (iPS cell) therapy with generous funding, acquisitions, and strategic partnerships.
MELBOURNE, Australia, June 21, 2018 — Australian stem cell and regenerative medicine company Cynata Therapeutics Limited (ASX:CYP) is pleased to announce positive safety and efficacy data from a day 28 analysis of patients in Cohort B of its Phase 1 clinical trial of CYP-001, the Company’s lead Cymerus™ mesenchymal stem cell (MSC) product candidate, in steroid-resistant acute graft-versus-host disease (GvHD). [Read more…]
Patients in Cohort A Respond Well, 1st Patient in Cohort B Dosed in Cynata’s CYP-001 Trial
Australian stem cell company, Cynata Therapeutics has released exciting early results from its ongoing clinical trial in the UK utilizing an iPS cell-derived mesenchymal stem cell (MSC) therapeutic product. [Read more…]
What is Cynata’s Cymerus™ Technology?
The Cymerus™ technology is a stem cell manufacturing platform being developed by Cynata Therapeutics Limited (ASX: CYP), an Australian regenerative medicine company. The Cymerus™ technology utilizes induced pluripotent stem cells (iPSCs) originating from an adult donor as the starting material for generating mesenchymoangioblasts (MCAs), and subsequently, for differentiating the cells into mesenchymal stem cells (MSCs). [Read more…]
- Cynata Pre-IND meeting with the US FDA completed successfully
- FDA confirms CymerusTM manufacturing dossier meets expectations
- Clear path determined for preclinical and clinical protocol requirements for product development in US
- Potential to take advantage of fast-track provisions under the new 21st Century Cures Act
Melbourne, Australia; 5 July 2017: Australian stem cell and regenerative medicine company, Cynata Therapeutics Limited (ASX: CYP), has received written advice from the United States Food and Drug Administration (FDA) regarding the regulatory approval path for Cynata’s proprietary CymerusTM mesenchymal stem cell (MSC) products in the US. This advice follows a pre-Investigational New Drug (pre-IND) meeting (announced 19 April 2017), which Cynata recently held with the FDA’s Office of Cellular, Tissue and Gene Therapies.
The FDA confirmed that the scope and substance of Cynata’s “Chemistry, Manufacturing and Controls” (CMC) dossier is commensurate with its expectations, which indicates that CymerusTM MSC products are expected to be of suitable quality for clinical trial use in the US. [Read more…]