@Investek raised the question of CUV011 and I have been thinking about this too. CUV011 is a randomised double-blind placebo-controlled study of 24 months duration in 85 patients, involving 10 specialist skin cancer centres across Australia and Europe for Organ Transplant Recipients (OTRs). There are probably better researchers out there than me so here are my sources. The various Aust. Euro and US websites for clinical trials. The March 2018 Clinuvel Communique. The CUV release to the ASX on 15/12/2011 (page 33 Hotcopper). Finally the European Medicines Agency (EMA) CMHP Assessment Report on Scenesse dated 23/10/2014.
IMO this trial is ONGOING and will be used to give a wealth of evidence supporting DNA REPAIR. The 2011 interim release to the ASX states strong safety data including no 'drug-drug' interference in OTRs. It is also mentioned OTRs are up to 250 times more likely to develop skin cancers due to immuno suppressive drugs. (Now we must remember XP patients are around 10000 times more likely to get skin cancers and CUV must have had some good data to get access to these patients).
Jump to end of 2014 and the EMA report says about CUV011 "The study is still ongoing, and “the study is still blinded” ". Wow. And then in the 2018 Communique the quote about CUV011 is "The preliminary safety data from this complex study are positive and give us, thus far, no reason for concern."
Finally the EU clinical trials register for CUV011 shows Italy and France as still 'ongoing' while Sweden, Germany and Belgium are 'completed'.
The patient numbers for the 5 EU members add up to 85 (Sweden 10, Germany 15, France 15, Italy 20, Belgium 25) but I believe Swiss and Australian patients may also be involved as up to 200 subjects seem to be listed. Like I said some better researcher can find all this stuff. Overall I might be putting 2 and 2 together and getting 5. But I reckon all this data is going to be announced as part of the DNA REPAIR program and leading to some pretty astounding results as longitudinal studies of this nature are rare but very strong in the evidence they may gather. I believe Clinuvel may really be onto something with DNA REPAIR, all those years of data must give them strong confidence (as well as giving Ethics committees confidence in granting access to vulnerable XP sufferers) and 2021 read-outs for new studies involving XP patients and healthy volunters - CUV150 and CUV151 are going to be ground breaking.
DNA REPAIR, DNA REPAIR, SKIN CANCER, XP, it's going to be HUGE. Did I mention DNA REPAIR.
All IMO, DYOR
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