Cynata Announces First Clinical Study Utilizing MSCs Manufactured by Cymerus™ Platform
Cynata Therapeutics, a stem cell and regenerative medicine company listed on the Australian stock exchange (ASX: CYP), released major news today by announcing that mesenchymal stem cells produced using its Cymerus™ manufacturing platform will be utilized in a Phase 1 clinical study involving patients with steroid-refractory GvHD.
The Clinical Trial Company Ltd was identified as the contract research organization (CRO) that Cynata has engaged to conduct the study.
CYP-001 is the lead mesenchymal stem cell (MSC) product manufactured using Cynata’s unique Cymerus™ technology, a platform which allows MSCs to be produced from a single donation given by an individual donor. The Cymerus™ technology creates induced pluripotent stem cell (iPSC) derived MSCs, solving a key issue now limiting the therapeutic use of MSC – the ability to produce consistent, scalable MSCs for clinical-grade use.
MSCs have shown promising results in the treatment of GvHD, as MSCs are modulatory cells that can alter a recipient’s immune response and reduce inflammation. Furthermore, MSCs are currently being explored in nearly 500 clinical trials worldwide, so their therapeutic potential is well-vetted. However, robust technologies for scaling and standardizing the manufacture of MSCs are scare.
Cynata Therapeutics is a promising stock for regenerative medicine investors to watch, because the company’s ability to produce consistent, scalable MSCs for clinical-grade use will substantially expand therapeutic applications for the cell type.
While Cynata Therapeutics is an Australian-based company, it was founded on technology developed at the University of Wisconsin, an institution known for the work of Dr. James Thomson, whose team first isolated human embryonic stem cells (hESCs) in 1998 and derived induced pluripotent stem cells (iPSCs) from adult human cells in 2007.
The company has also established global partnerships, aligning itself with Harvard University to test toxin-secreting stem cells for the treatment of cancer and the University of Sydney to test the potential therapeutic efficacy of Cymerus™ MSCs in animal models of myocardial infarction.
To see the full press release issued today by Cynata Therapeutics describing their involvement with The Clinical Trial Company (TCTC), see the complete announcement below.
Cynata Engages CRO to Conduct GvHD Clinical Trial
• Cynata engages The Clinical Trial Company Ltd as CRO for upcoming Phase 1 clinical study
• First clinical study with CymerusTM MSCs will be conducted in patients with steroid-refractory GvHD
Melbourne, Australia; 5 November 2015 – Australian stem cell and regenerative medicine company, Cynata Therapeutics Ltd (ASX: CYP), announced today that it has engaged The Clinical Trial Company Ltd. (TCTC) as the Contract Research Organisation (CRO) for Cynata’s upcoming Phase I clinical study, which will investigate CYP-001 as a treatment for steroid-refractory graft versus host disease (GvHD). This engagement follows planning and logistics development undertaken during the earlier part of this year for the clinical trial.
GvHD is a complication of bone marrow transplantation and related procedures. It is an extremely debilitating condition, in which transplanted cells attack the recipient. Steroids are the first-line treatment for GvHD, but when that proves to be ineffective (steroid-refractory GvHD), the prognosis is extremely poor, with mortality rates of up to 80%.
CYP-001 is the lead mesenchymal stem cell (MSC) product manufactured using Cynata’s unique CymerusTM technology, which enables large scale production MSCs from a single donation from a sole donor. MSCs have shown significant promise in the treatment of GvHD, due to MSCs ability to modulate a recipient’s immune response and reduce inflammation.
Formed in 2002, TCTC is a privately owned full-service clinical research provider, which specialises in studies involving advanced therapies, including stem cells. TCTC has offices in the UK, USA, Canada, Australia and Singapore, and field-based staff in a range of additional locations. TCTC will manage the conduct of this important Phase I clinical trial for Cynata.
Cynata Vice President of Product Development, Dr Kilian Kelly, said “This clinical trial is a critically important milestone in the development of the Cymerus™ platform technology, so it is of paramount importance that we select the right CRO. Clinical trials with stem cells present a number of unique challenges, and we believe TCTC is ideally suited to manage this trial, given its specialisation and extensive experience in the field of advanced therapies and regenerative medicine. We look forward to working with TCTC on this initial clinical study of CYP-001. Cynata has further meetings scheduled with regulatory bodies and subject to the outcome of those meetings we expect to commence the trial in the first half of 2016.”
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, Cymerus™, originating from the University of Wisconsin-Madison, a world leader in stem cell research. The proprietary Cymerus™ 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. Cymerus™ does so through the production of a particular type of MSC precursor, called a mesenchymoangioblast (MCA).
The Cymerus™ MCA platform provides a source of MSCs that is independent of donor limitations and provides a potential “off-the-shelf” stem cell platform for therapeutic product use, with a pharmaceutical 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.