The Cymerus Process, page-94

TRIAL UPDATES


CLI Phase 2:

Despite the trial being currently put on hold and funds/resources being applied otherwise, significant progress seems to have been made and has gone unnoticed:



The trial was registered on EUCTR end of last year, but has been updated recently:
https://apps.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2019-001361-33-GB
(link is currently dead, but should be back up soon)

When we received NHS HRA approval for our P1 trial back in 2016, it was considered "market sensitive":


https://www.cynata.com/wp-content/uploads/2016/12/16.12.13.Cynata-Receives-NHS-HRA-Approval-for-Clinical-Study.pdf


OA Phase 3:


https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=379726&isReview=true

Phase 3 could potentially be the final step before marekting a product, hence an assessment of cost saving could be very useful in order to determine a price/reimbursement/Medicare Benefit.


And more preclinical data today (BOLD = me):

"Additional efficacy data from preclinical disease model on recovery of cardiac function post heart attack help to explain the previously announced superior therapeutic effects demonstrated by Cymerus MSC treatment when compared to conventional bone marrow- derived MSC treatment and placebo"

"This builds on the significant dataset demonstrating the potential benefits of treatment with Cynata’s Cymerus MSCs and Cynata will continue to work with relevant parties to determine the next steps for this program and broader clinical development"

"Dr Kilian Kelly, Cynata’s Chief Operating Officer, said: “With the benefit of this further data we are now able to better understand the beneficial effects of our Cymerus MSCs in this model of heart attack. It is particularly notable that the latest results are consistent with the greater benefit demonstrated by Cymerus MSCs over BM-MSCs in the earlier studies of heart function. Given the scalability and consistency advantages of the Cymerus MSC manufacturing process over conventional processes, the potential therapeutic advantages shown here are particularly interesting as a putative treatment for post heart- attack cardiac damage.”"