Australian stem cell company Cynata Therapeutics announced that it has filed an application to the UK Medicines and Healthcare products Regulatory Agency (MHRA) to commence a Phase I clinical trial for its lead product, CYP-001. CYP-001 is an iPSC-derived mesenchymal stem cell product that is anticipated to be the world’s first allogeneic iPSC product to enter a clinical trial.
To learn more, read the full press release issued by Cynata Therapeutics, printed with permission from Cynata CEO, Dr. Macdonald.
Cynata Files Application to Commence Phase 1 Clinical Trial
Melbourne, Australia; 1 August 2016 — Australian stem cell and regenerative medicine company, Cynata Therapeutics Limited (ASX: CYP), announced that it has filed a Clinical Trial Authorisation application for its lead CymerusTM mesenchymal stem cell (MSC) product, with the UK Medicines and Healthcare products Regulatory Agency (MHRA).
The proposed Phase 1 study will be conducted in patients with graft-versus-host disease (GvHD), a potentially fatal disease that often follows a bone marrow transplant procedure and occurs when the immune cells in the donor material (the graft) attack the recipient’s tissues (the host) as “foreign”. Bone marrow transplants are used in thetreatment of certain cancers including leukaemia. The application to the MHRA follows a successful scientific advice meeting which took place earlier this year.
“The application to commence our Phase 1 study with the MHRA represents the culmination of an intensive program of manufacturing process development, safety evaluation and proof-of-concept studies. The successful outcomes from our product development activities over the past two-and-a-half years have allowed us to move things forward,” said Cynata Vice President of Product Development, Dr Kilian Kelly. “We have been very pleased with the result of our pre-clinical program and are eager to advance to an initial clinical study with our induced pluripotent stem cell (iPSC) derived MSC therapeutic product, CYP-001.”
About Cynata Therapeutics (ASX: CYP)
Cynata Therapeutics Limited (ASX: CYP) is an Australian stem cell and regenerative medicine company that is developing a therapeutic stem cell platform technology, CymerusTM, originating from the University of Wisconsin-Madison, a world leader in stem cell research. The proprietary CymerusTM technology addresses a critical shortcoming in existing methods of production of mesenchymal stem cells (MSCs) for therapeutic use, which is the ability to achieve economic manufacture at commercial scale.
CymerusTM utilises induced pluripotent stem cells (iPSCs) to produce a particular type of MSC precursor, called a mesenchymoangioblast (MCA). The CymerusTM platform provides a source of MSCs that is independent of donor limitations and provides an “off-the-shelf” stem cell platform for therapeutic product use, with a pharmaceutical product business model and economies of scale. This has the potential to create a new standard in the emergent arena of stem cell therapeutics and provides both a unique differentiator and an important competitive position.
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