Australian National Health and Medical Research Council (NHMRC) will fund a major second phase of clinical trial in osteoarthritis for CYNATA THERAPEUTICS LIMITED (ASX: CYP).
Cynata being a biotechnology company has its specialization in cell therapeutics. The company has a unique Cymerus technology which deals with the complexity and challenges of manufacturing the cells at a large commercial scale.
Mesenchymal stem cells (MSCs) have substantial potential healing capacity for several diseases for various unmet medical needs. The company uses leading technologies from the world’s very distinguished stem cell centre which unlocks an unlimited expansion potential. This will benefit the company and its commercial partners to source all the cells as required from a single blood donation.
- The second phase of the clinical trial of 448-patient in osteoarthritis expected to commence in the second half of FY 2019.
- There is no cash contribution from Cynata, in fact, the entire costs of the trial will be funded by NHMRC.
- Cynata will supply Cymerus MSCs to expedite and facilitate the trial.
- This is one of the largest MSC trials run till date. It represents a milestone for Cynata, showcasing its capacity to produce MSCs at a larger scale.
- The company will retain its full commercial rights to the use of Cymerus MSCs in osteoarthritis. This will be a market opportunity for the company, and the approximately forecasted worth will be nearly around US$11.6 billion globally by 2025.
- Osteoarthritis becomes the third Phase 2 indication for Cynata. This highlights the demand for the company’s Cymerus MSCs in multiple indications.
- The trial will take place in Sydney and Tasmania. This will be managed by a world-class clinical team, which will be led by Professor David Hunter of the University of Sydney.
As stated by Dr. Kilian Kelly, the vice president of Cynata that the clinical trial in patients with osteoarthritis is a very significant achievement for the company. This will be the largest clinical trial till date with Cymerus MSCs. The trial will give access to Cynata to the enormous amount of clinical data with a tremendous commercial opportunity.
He also mentioned that this will be among the largest clinical trials ever conducted with MSCs from any source. With an enormous area to explore and unmet need for disease-modifying agents in osteoarthritis, the company is eager to explore the prospective role of Cymerus MSCs in improving the quality of these patients’ lives.
The overview of the clinical trial establishes that Phase 2 clinical trial aims to assess the effect of Cymerus MSCs compared to placebo on clinical outcomes and knee joint structure over a two-year period, in 448 patients with osteoarthritis of the knee. As prior clinical research has shown that MSCs can apply several important effects that may improve outcomes in patients with osteoarthritis, including the release of cytokines and growth factors that reduce inflammation and enhances tissue repair, formation of new blood vessel, and regeneration of compromised cartilage.
The prospect of the company looks positive with the clinical trial on board. It may be a significant achievement for both the company and the medical fraternity, over its successful completion. The stock is currently trading at $0.995 with a market capitalization of 98.74 million. The stock posted a YTD return of almost 64.71%.
However it has been maintaining a downward trend since the past six months with a negative return of -28.21%.
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