Pluriomics B.V. is a Dutch company that specializes in the “production and industrialization of high-quality, fully functional hiPS cells-derived cardiovascular cell types and on the development and realization of electrophysiology-, biochemistry- and contraction-based assays for predictive safety pharmacology, toxicology testing and efficacy screening.” [Read more…]
Cynata Prepares for Phase 1 Clinical Trial of iPSC-derived MSC Product CYP-001
Australian stem cell company Cynata Therapeutics announced that it plans to file an application for regulatory approval within the UK to initiate a Phase 1 clinical trial of its iPSC-derived MSC product CYP-001 in July 2016.
This is a significant announcement, because it will be the world’s first allogeneic iPSC clinical trial.
Cynata’s Cymerus™ technology utilizes iPSCs originating from an adult donor as the starting material for generating mesenchymoangioblast (MCAs), and subsequently, for differentiating the cells into mesenchymal stem cells (MSCs). The outcome is that Cynata can produce MSCs in unlimited quantities, in uniform batches, from a single donor, and at low cost. The company’s lead product produced using the s Cymerus™ technology is CYP-001.
This clinical trial will also be the first time that the company’s unique Cymerus technology is tested in humans.
Will You Be Attending? FDA Reschedules Part 15 Public Hearing for September 12-13 (5 Month Delay)
Recently, we explored the overwhelming response received by the FDA for participation in its Part 15 Hearing intended to review “Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products.”
With approximately 600 registrations and 100 people interested in presenting, it was clear that individuals across country are concerned about these draft guidances that appear to be a further restriction on stem cell therapy within the U.S.
As a result of this massive registration response, the FDA cancelled the original April 13, 2016, hearing date and announced that it would be rescheduled for an undetermined date. [Read more…]
Pluriomics Awarded €3.2M to Advance Cardiovascular Drug Discovery – Reducing Time, Cost, & Late Stage Attrition of Drug Candidates
Pluriomics is a Dutch company that specializes in the “production and industrialization of high-quality, fully functional hiPS cells-derived cardiovascular cell types and on the development and realization of electrophysiology-, biochemistry- and contraction-based assays for predictive safety pharmacology, toxicology testing and efficacy screening.”
In news released today, the company announced that it will receive a €3.2M grant under the Horizon 2020 SME instrument programme to advance cardiovascular drug discovery.
The company also announced last month that it will lead a €2.0 million Eurostars consortium for the development of a novel in vitro organ-on-a-chip heart failure model for drug discovery and development.
To learn more about the €3.2M grant under the Horizon 2020 SME instrument programme, read the full press release below, printed with permission from Celine Hechard, PhD, VP Business Development & Marketing at Pluriomics. [Read more…]
Axiogenesis Supports CiPA’s Aim to Improve Current Regulatory Guidances
In 2006, induced pluripotent stem cells (iPSCs) were first introduced by Shinya Yamanaka at Kyoto University in Japan. 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). As a result of this advance, one of the most important applications for induced pluripotent stem cells has become their use as predictive technologies to support and streamline drug safety testing. [Read more…]
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