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CUV, CLINUVEL PHARMACEUTICALS LIMITED
Desert Rat
post Posted: Yesterday, 09:08 AM
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Singapore Vitiligo Trial: Very small trial: n=8 in the phase I randomized study of UV-B +/- afamel.), and n=13 in the single-arm (combination) open-label phase 2 part. It was submitted as a Letter to the Editor of the Journal of the Amer. Acad. of Derm. Afamelanotide (Scenesse) 16 mg implants, were administered every 28 days, six in total, in Fitzpatrick skin types IV thru VI (dark skin types) combined with narrow-band UV-B phototherapy. The pooled analysis included all 18 patients that received the combination therapy with p <0.05 by both the VASI and the Vitiligo European Task Force (VETF) vitiligo area measurements. The low recruitment was a result of possible “social anxiety” over the general skin darkening in non-vitiligo areas perceived as a negative in the Asian community. In that regard, the slight improvements in vitiligo-specific quality of life measurements for combination therapy patients were not statistically significant.

file:///C:/Users/Robert/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/SU7ED1X1/PIIS0190962220301195.pdf



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Starfire
post Posted: Yesterday, 08:34 AM
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To all the australiens
Have a great and happy Australian day !
And lets look forward to hopefully some good numbers coming Friday


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Dr Wally
post Posted: Jan 26 2020, 11:27 PM
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In Reply To: macgyver's post @ Jan 26 2020, 09:44 PM


Hey MacDaddy, you really are "off your rocker".




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“” The discovery of the endogenous melanocortin agonists in the 1950s have resulted in sixty years of melanocortin ligand research.””

The never ending quest to have Afamelanotide (peptide) accepted for its potent ability to stimulate a natural photoprotective,cancer preventative, therapeutic “tan” was accomplished in 2019.

Regulator ignorance, bias, and stubborn resistance to Scenesse are the primary reasons behind this glacial journey. The evidence should be clear to all by now.
 
Patrick Mcloughl...
post Posted: Jan 26 2020, 10:34 PM
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Every stock has its story. However, this year one biotech caught the eyes of investors and opened their wallets. CUV stock rose by 150% over the past 12 months and with recent FDA approval success is imminent. Yeah Yeah we have all heard this before. So why is this biotech different? Click below and you will see why?

https://youth-investment-group.com/2019/12/...DFBYhqp70ft4tLI




 
macgyver
post Posted: Jan 26 2020, 09:44 PM
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In Reply To: sharelooker's post @ Jan 26 2020, 08:43 PM

They probably wanted to know which Fitzgerald skin classification Scenesse would be able to treat effectively. To me it seemed an exploratory trial more than anything, especially given the small number of patients. Those patients in Singapore may have ranged from Type 2 to Type 5 (Malays, Indonesians, Indians and Chinese), and with Vallaurix being established there along with Singaporean pharmaceutical expertise and business-friendly environment (not to mention PWs tax retreat), Clinuvel figured it was optimal to do the trial there.

 
sharelooker
post Posted: Jan 26 2020, 08:43 PM
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In Reply To: sharelooker's post @ Jan 26 2020, 10:19 AM

A major limitation of this study was the low recruitment rate because of the darkening effect of SC which is culturally not acceptable in asia. I'm still wondering why they did this study. They should have know this problem.

 

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Johnny H
post Posted: Jan 26 2020, 10:58 AM
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In Reply To: sharelooker's post @ Jan 26 2020, 10:19 AM

P value for a reduction in total body VASI score was <.001.





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Clinuvel until my bowels release for the last time.

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sharelooker
post Posted: Jan 26 2020, 10:19 AM
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It seems, they've published the results of the recent vitiligo study in singapore.

Afamelanotide Implants and Narrow-band Ultraviolet B Phototherapy for the Treatment of Nonsegmental Vitiligo in Asians

https://www.sciencedirect.com/science/artic...90962220301195#!


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sharelooker
post Posted: Jan 25 2020, 11:37 PM
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In Reply To: sharelooker's post @ Jan 24 2020, 11:32 PM

The take home message of this publication is that activation of MC1R by MT2 oder SC results in the ignition of multiple pathways in order to slow down or prevent melanoma growth. In XP where different XP-proteins are mutated and cannot do their job properly, other mechanisms like downregulation of COX II, upregulation of PTEN etc. can compensate it. Moreover there will be a protective tan.

In my opinion, it makes perfectly sense to test SC in XP.


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sharelooker
post Posted: Jan 25 2020, 12:08 AM
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Further nice work with NDP-MSH. The peptide was conjugated to the checkpoint blocker avelumab. Checkpoint blockers like avelumab, pembrolizumab, ipilimumab etc. are the most effective drugs against melanoma and other solid tumors. With the targeting effect of NDP-MSH they are even more effective!

QUOTE
A tumor-targeted immune checkpoint blocker


Published online 2019 Jul 22

ABSTRACT
To direct checkpoint inhibition to the tumor microenvironment, while avoiding systemic immune activation, we have synthesized a bispecific antibody [norleucine4, d-Phe7]-melanocyte stimulating hormone (NDP-MSH)-antiprogrammed cell death-ligand 1 antibody (αPD-L1) by conjugating a melanocyte stimulating hormone (α-MSH) analog to the antiprogrammed cell death-ligand 1 to (αPD-L1) antibody avelumab. This bispecific antibody can bind to both the melanocortin-1 receptor (MC1R) and to PD-L1 expressed on melanoma cells and shows enhanced specific antitumor efficacy in a syngeneic B16-SIY melanoma mouse model compared with the parental antibody at a 5 mg/kg dose. Moreover, the bispecific antibody showed increased infiltrated T cells in the tumor microenvironment. These results suggest that a tumor-targeted PD-L1-blocking bispecific antibody could have a therapeutic advantage in vivo, especially when used in combination with other checkpoint inhibitors.

Reviewers: P.S.K., Stanford University and Chan Zuckerberg Biohub; and D.A.S., Yale University.


https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6689898/



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