You have raised some very valid points, including the huge number of amputations [in the US] as a result of DFU.
According to Michigan Medicine:
https://www.uofmhealth.org/conditions-treatments/podiatry-foot-care/frequently-asked-questions-diabetic-foot-ulcersNo need to go that far though. The NSW Government Health South Eastern Sydney Local Health District "Wound - High Risk Foot Ulcer Management" mentions, "Evidence shows that up to 28% of people who have a diabetes related foot ulcer (DFU) will require an amputation3. People who have had a diabetes related foot ulcers are at a lifelong risk of re-ulceration, with 40% of re-ulceration occurring within one year of the foot ulcer ‘healing’4," (
https://www.seslhd.health.nsw.gov.au/sites/default/files/documents/SESLHDPR%20653%20-%20High%20Risk%20Foot%20Ulcer%20Management.pdf).
A recent statement (not in relation to our trial) from Professor Fitridge (contact person of our trial at the Central Adelaide Local Health Network location), dated 30th January 2024:
https://kidneydiabetesresearch.org.au/news-stories/latest-news/new-clue-to-treating-diabetic-foot-ulcers/The aim of DFU treatment "is to obtain healing as soon as possible. The faster the healing of the wound, the less chance for an infection," (
https://www.uofmhealth.org/conditions-treatments/podiatry-foot-care/frequently-asked-questions-diabetic-foot-ulcers).
Rapid Wound Closure is key, as that decreases the risk of infections and subsequent amputations.At this point, looking at our initial results of the first 6 patients (thank you again to our retiree-not for sharing it with the "sophisticated" investors first to give them a chance to make a quick buck, instead of the loyal great unwashed) as well as the interim data of the 16 patients after 10 weeks, highlight the optimism of investors including
@OceanView and
@bedger here:
After 21 days the mean % ulcer surface area is at about 70% in the 3 treated patients vs about 30% in the 3 patients that received Standard of Care (SoC) and still being amost double after 28 days:
https://app.sharelinktechnologies.com/announcement/asx/6c29a708f46ae8423f6d37555544d028The initial data in the first 16 patients after 10 weeks showed:
https://app.sharelinktechnologies.com/announcement/asx/77f3e4f38a0bc5be2ee008ac78761d55Random fact, that % is almost idential to the wound healing after 3 days in CTM CRC's preclinical study when comparing dressings seeded with Cymerus MSCs vs commercially available bone marrow-derived MSCs:
https://files.cynata.com/348/18.05.31.Cynatas-MSCs-Effective-in-Model-of-Diabetic-Wounds.pdfThe wound healing acceleration was also seen in a pre-clinial model here:
https://tekcyte.com/cypatch/However, I agree with
@Pledge's comments (regardless whether suggested or not and I definitely disagree with the delivery) that we are still miles off from approval (which is also what
@bedger indicated). Approval after P2 in cancer treatments is something that gains momentum, including international collaboration in the form of Project Orbis, but I can't see it happening especially with the FDA when it comes to MSCs, although changes appear to be happening as a direct result of MSB's previous BLA interactions re SR-aGvHD.
It is yet however to be seen how the FDA is evaluating the first step of our manufacturing approach, since we utilise iPSC-derived MSCs. Whilst the likes of Fate and also Cynata have approached the FDA during the IND process, the BLA review proccess is different as seen in MSB's example and that didn't involve an iPSC-MCA process for the FDA to consider. CYP however appears to be pro-active, which can be seen in the form of research output from Margeaux Hodgson-Garms etc.
Different story in Japan however, where approval after succesful P2 data would have been more realistic. In light of meetings with the PMDA that took place in 2018, I still think not entering the Japanese market is a missed opportunity. But given funding contraints and FF not being a licence anymore to operate (and fund) the trial in Japan, additional promising data (DFU, GvHD, OA etc.) might see new partnering opportunities in Japan (as well as other markets). Hopefully Dr Kroll can deliver on that front since we don't need any more "stem cell whisperer" on our payroll. Too many promised "superstars" and "rockstars", that fell nothing but short of expectations of the "unsophisticated" supporters.
Hopefully, DFU will be the first unaMENDed step of many to get us back on track and the SP back to where we all would like it to see again.
Thank you for any all the shared optimism as well as warnings and entertainment, on and off HC.
(20min delay)