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…]
FDA Meeting Provides Clear Path for Cynata US Development Plans
- 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…]
Cynata Files New Patent Application for Cymerus™ Stem Cell Technology in Oncology
- 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
Top 10 Differentiators for Axiogenesis within the Global iPSC Marketplace
Groundbreaking experimentation in 2006 by Shinya Yamanaka (Kyoto University, Japan) led to the introduction of induced pluripotent stem cells (iPSCs). These are adult cells that are isolated and then reprogrammed into embryonic-like stem cells through the expression of a specific set of embryonic genes. Yamanaka’s discovery, which earned him the Nobel prize in 2012, enabled the use of human cells in stem cell science, bypassing the use of embryonic stem cells (ESCs). Without the ethical problems associated with ESCs, a large and diverse market for human iPSC research tools has emerged.
Founded in 2001 and headquartered in Cologne, Germany, Axiogenesis initially focused on generating mouse embryonic stem cell derived cells and assays. After Yamanaka’s groundbreaking iPSC technology became available, Axiogenesis was the first European company to license and adopt Yamanaka’s iPSC technology in 2010. [Read more…]
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.
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