Company Name: Cynata Therapeutics
Announcement Date: 01/08/2016
Announcement Category: Contract/Partnership, Other, Product launch/update, Team Update
Announcement Content:
ASX ANNOUNCEMENT 1 August 2016
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 Cymerus™ 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 the
treatment 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-ahalf
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.”
CONTACTS:
Dr Ross Macdonald, CEO: Tel: 0412 119343; email [email protected]
Dr Stewart Washer, Executive Chairman: Tel: 0418 288212; email [email protected]
Kirin Smith, Chief Operations Officer, Investor Contact, + 1 646-863-6519, [email protected]
Sean Leous, Chief Communications Officer, Media Contact, +1 646-863-8998, [email protected]
Rudi Michelson, Monsoon, Australia Media Contact, 0411 402 737, [email protected]
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™ utilises induced pluripotent stem cells (iPSCs) to produce a particular type of MSC precursor,
called a mesenchymoangioblast (MCA). The Cymerus™ 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.
Announcement URL: http://cynata.com/wp-content/uploads/2016/08/16.08.01.Cynata-Files-Application-to-Commence-Phase-1-Clinical-Trial.pdf
About Cynata Therapeutics:
Cynata Therapeutics Limited is an Australian stem cell and regenerative medicine company that is developing a therapeutic stem cell platform technology, Cymerus™, using discoveries made at the University of Wisconsin-Madison (UWM). UWM is a world-renowned leader in stem cell research, in particular for the work by Professor James Thomson's group, which included the first successful isolation of human embryonic stem cells in 1998, and the derivation of induced pluripotent stem cells (iPSCs) from human adult cells in 2007. Professor Igor Slukvin, a co-founder of Cynata, was also a member of the team that conducted UWM's pioneering iPSC research.
Cynata's Cymerus™ platform stem cell technology is based upon extremely important and versatile stem cells known as mesenchymoangioblasts (MCAs). MCAs are a precursor of mesenchymal stem (or stromal) cells (MSCs) which are at the forefront of a new generation of treatments being investigated for such devastating diseases as osteoarthritis, Crohn’s disease and heart disease. Cynata’s proprietary technology utilizes iPSCs originating from an adult donor as the starting material for generating MCAs and in turn for manufacturing the MSC therapeutic product.
Go to Company Profile for: Cynata Therapeutics
Announcement Contact: Dean Felton, Monsoon Communications 0411 698 499
