Dr. Itzchak Angel, CEO of the Israeli stem cell company, Accellta, has more than 30 years of experience guiding the business development efforts of new and established companies across the Israeli pharmaceutical industry. Dr. Angel was formerly Vice President of R&D at Proteologics Ltd. and at D-Pharm Biopharmaceuticals. Before those positions, he served as the head of pharmacology in Synthelabo (now Sanofi) where he launched blockbuster drugs such as Xatral, Ambien and Mizollen into the marketplace. [Read more…]
This is an exciting addition to my recent interview with Accellta’s CEO, Dr. Itzchak Angel, who highlighted Accellta’s unique technologies for enabling large scale growth of cells in suspension. This interview features insights from Eran Cohen, Accellta’s head of business development and intellectual property (IP) officer.
- 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…]
- Application filed with IP Australia would expand patent estate to immunotherapy
- Creates new opportunities in the growing field of immunotherapy and reinforces a position in oncology
In breaking news released earlier this month, Cynata Therapeutics Limited (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 .
Click here for the full ASX announcement: http://cynata.com/wp-content/uploads/2017/05/17.05.16.Treatment-Commences-in-Cynatas-World-First-Clinical-Trial.pdf
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. [Read more…]