Hi
@JB1975,
I thought the announcement was quite clear and easy to understand, even for someone that appreciates interviews with a fake Dr and therefore falls into the demographics "not the sharpest knives in the drawer":
Our
original MEND trial, which utilised the
NSW Heath Early Phase Clinical Trial (EPCT) Framework* and as such was limited to NSW - by the way, it was and still is a collaboration between Cynata and the Cerebral Palsy Alliance Research Institute and investigators from the COVID-19 Stem Cell Treatment (CSCT) Group - was looking to treat patients with mild ARDS
strictly caused by COVID19 and appears to have been based on assumptions made by all parties involved - based on the situation at the time.
According to the latest
CYP ASX announcement, the aMENDed trial is now looking for patients with mild ARDS (P/F ratio <300 mmHg within the past 24 hours, but not sustained for more than 24 hours at the time of enrolment + ICU admission), caused by COVID-19,
BUT ALSO:
- Sepsis. The most common cause of ARDS is sepsis, a serious and widespread infection of the bloodstream.
- Inhalation of harmful substances. Breathing high concentrations of smoke or chemical fumes can result in ARDS, as can inhaling (aspirating) vomit or near-drowning episodes.
- Severe pneumonia. Severe cases of pneumonia usually affect all five lobes of the lungs.
- Head, chest or other major injury. Accidents, such as falls or car crashes, can directly damage the lungs or the portion of the brain that controls breathing.
- Others. Pancreatitis (inflammation of the pancreas), massive blood transfusions and burns.
Source:
https://www.mayoclinic.org/diseases-conditions/ards/symptoms-causes/syc-20355576As such, our Pilot Study Phase 1/2 in all cause ARDS expansion deserves to be described as a substantial increase of the pool of eligible subjects in my opinion and 24 subjects for a Pilot Study is not unusual:
Source:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6560575/Hopefully we see the NSW trial being extended to VIC as well, as I note the latest slide doesn't mention VIC at this stage.
Whether or not our results will be meaningful, we will see. I do however much rather see a small Phase 1/2 in a new indication with a potential big upside (Novartis) to be a learning experience than 3 consecutive Phase 3 clinical trials, of which some have been modified along the way and went on for years, to not meet the primary endpoints and instead having to undertake an extensive amount of data mining, essentially leading to statistics that the product works in 100% of patients with the full name Barney Gumble that were also born on 20 April 1956.
Perhaps worthwhile checking and comparing how much more it would have cost us to start an all cause ARDS trial if it wasn't for our collaborations and of course COVID-19, which enabled accelerated approval in first place. The cells were accounted for our CLI trial anyway but weren't able to be used for the unforeseeable future at that time.
2021: We now have one OA P3 trial underway, an all cause ARDS P1/2 trial is now also underway, an MoU has been announced for a P2 trial in Diabetic Foot Ulcers which sounds like is making good progress and the fake Dr interview revealed that our P2 renal transplant seems to be far advanced also - and we have cash in the bank that allows us to see most of our own new trials through.
No matter how harsh your current assessment of this company based on your (and my) previous experience may be (and very well warranted as I share your frustration), the hibernation seems to be finally over and we finally see the changes that we have all wished for from the start. Personnel and investor changes took place over the past year and this may have well added to (caused?) this change. Time will tell if this change is a lasting one.
Cynata - the past performance may not be indicative of future results
:
(20min delay)