Clinuvel

macgyver

Well-known member
Not meaning to be alarmist but regarding the AIS trial completion dates, I was under the impression that before the latest date change there was to be a follow up period following the primary completion date (6 months?). Now both the primary and study completion dates are the same. I’d have to go back through the posts looking for original completion dates as Clinical trials.Gov no longer shows them, but my first impression about the new completion dates was they were using the follow up period to gauge how much improvement in disability had occurred post discharge as measuring the overall efficacy of Afamelanotide.

There’s two elements that makes me think Afamelanotide does work in AIS on some level: the description of the elderly gentleman’s stroke treatment described in the AIS patent, and PWs comment in the Malcolm Bull investor update interview where said he was pleased with the results. But perhaps the results are not overwhelming, or more to the point you can’t really gauge the benefits of treatment until you see how much disability the patient has say 6 months after treatment. I’m assuming once a patient leaves hospital there’s is still a lot of work to do in terms of rehabilitation etc, so to determine just how successful treatment was in relation to non treated stroke patients you can’t really know after Day 42. Certain parameters could show improvement (perhaps marginally as in 5% improved blood flow, 10% decrease in T-Max etc) yet Day 42 might not show the level of improvement that was expected and so they are waiting the full 6 months after initial treatment to measure improvement in disability.

It could be nothing but it struck me as unusual to have both the primary and study completion dates finish the same time.
 
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macgyver

Well-known member
Not meaning to be alarmist but regarding the AIS trial completion dates, I was under the impression that before the latest date change there was to be a follow up period following the primary completion date (6 months?). Now both the primary and study completion dates are the same. I’d have to go back through the posts looking for original completion dates as Clinical trials.Gov no longer shows them, but my first impression about the new completion dates was they were using the follow up period to gauge how much improvement in disability had occurred post discharge as measuring the overall efficacy of Afamelanotide.

There’s two elements that makes me think Afamelanotide does work in AIS on some level: the description of the elderly gentleman’s stroke treatment described in the AIS patent, and PWs comment in the Malcolm Bull investor update interview where said he was pleased with the results. But perhaps the results are not overwhelming, or more to the point you can’t really gauge the benefits of treatment until you see how much disability the patient has say 6 months after treatment. I’m assuming once a patient leaves hospital there’s is still a lot of work to do in terms of rehabilitation etc, so to determine just how successful treatment was in relation to non treated stroke patients you can’t really know after Day 42. Certain parameters could show improvement (perhaps marginally as in 5% improved blood flow, 10% decrease in T-Max etc) yet Day 42 might not show the level of improvement that was expected and so they are waiting the full 6 months after initial treatment to measure improvement in disability.

It could be nothing but it struck me as unusual to have both the primary and study completion dates finish the same time.
I think I’m barking up the wrong tree. They couldn’t deviate from the Day 42 measurement as it’s in the primary endpoint. I haven’t found any information so far that shows the original dates as being different from one another. However, the revised study dates say data collection up until June 2022. Counting 42 days backwards from June 2022, add on another 2 months for assessing data for example and the last patient would have to start treatment before March 2022. I wonder if they haven’t even treated the 6th patient yet?
 
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Frogster

Well-known member
@macgyver the original entry on clinicaltrials.gov showed both primary completion and study completion as targeted for January 2022. You can compare the different study record versions on that same site to see any changes that have been made.
 
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macgyver

Well-known member
@Frogster Yes I did look at that but I assumed it just showed the date when the change was made not the change in itself. Ok thank you for the clarification. Disregard any and all prior posts😶
 

schlitzo

Well-known member
Heart-breaking news...most of you will want to donate no doubt....


Martin Shkreli, the former drug firm executive who ordered dramatic price hikes of a life-saving medicine, has been barred from the industry for life.
In a decision on Friday, Judge Denise Cote ordered him to repay $64.6m (£47m) in profits he made from the scheme.
She ruled that Mr Shkreli's actions had violated laws against monopolies.
Mr Shkreli is currently serving a prison sentence for defrauding investors.
But this decision is about action he took in 2015 to raise the price of Daraprim, a long-established medicine used to treat toxoplasmosis, from $13.50 to $750 - around 4,000% - overnight.
He also designed supply agreements to block competitors from offering a generic version of the unpatented medicine, which is used to treat the parasitic disease in pregnant women and patients with Aids.

The moves were unpopular, and earned him the nick-name "Pharma Bro".
Seven states and the Federal Trade Commission brought a lawsuit over the conduct in 2020, saying he had violated state and federal laws that ban anti-competitive conduct.
In her opinion, US District Judge Cote called Mr Shkreli the "prime mover" in the scheme.
"It was his brainchild and he drove it each step of the way," she wrote.
Vyera Pharmaceuticals, which Mr Shkreli founded and was previously known as Turing Pharmaceuticals, earlier agreed to pay $40m.
New York Attorney General Letitia James, one of the officials who brought the suit, celebrated the decision.

She said Mr Shkreli and his partner had illegally raised the "price of a life-saving drug as Americans' lives hung in the balance".
"But Americans can rest easy because Martin Shkreli is a Pharma Bro no more."
 

Sherlock

Well-known member
Heart-breaking news...most of you will want to donate no doubt....


Martin Shkreli, the former drug firm executive who ordered dramatic price hikes of a life-saving medicine, has been barred from the industry for life.
In a decision on Friday, Judge Denise Cote ordered him to repay $64.6m (£47m) in profits he made from the scheme.
She ruled that Mr Shkreli's actions had violated laws against monopolies.
Mr Shkreli is currently serving a prison sentence for defrauding investors.
But this decision is about action he took in 2015 to raise the price of Daraprim, a long-established medicine used to treat toxoplasmosis, from $13.50 to $750 - around 4,000% - overnight.
He also designed supply agreements to block competitors from offering a generic version of the unpatented medicine, which is used to treat the parasitic disease in pregnant women and patients with Aids.

The moves were unpopular, and earned him the nick-name "Pharma Bro".
Seven states and the Federal Trade Commission brought a lawsuit over the conduct in 2020, saying he had violated state and federal laws that ban anti-competitive conduct.
In her opinion, US District Judge Cote called Mr Shkreli the "prime mover" in the scheme.
"It was his brainchild and he drove it each step of the way," she wrote.
Vyera Pharmaceuticals, which Mr Shkreli founded and was previously known as Turing Pharmaceuticals, earlier agreed to pay $40m.
New York Attorney General Letitia James, one of the officials who brought the suit, celebrated the decision.

She said Mr Shkreli and his partner had illegally raised the "price of a life-saving drug as Americans' lives hung in the balance".
"But Americans can rest easy because Martin Shkreli is a Pharma Bro no more."
Karma is a bitch. :)
 

Jalu06

Well-known member
Research conducted by Imperial College London:

Impact of α-MSH on glucose tolerance in healthy participants: The first in human randomized, double-blind, placebo-controlled, physiological study

Background: Minimizing glycemic excursions and improving time in range glucose without increasing the risk of hypoglycemia and weight gain are among the current precious goals in the management of people with diabetes and the key targets for future novel therapeutics. Alpha-MSH is a 13 amino acid novel peptide, popular for its central appetite suppressing effect, was shown to exert a postprandial glucose lowering effect in mice models through melanocortin receptor 5 agonism without increasing the risk of hypoglycemia and thus it is important to conduct a human study to confirm the conservation of the effect of α-MSH on glucose tolerance in humans.

Objective: This study is aimed to examine the α-MSH efficacy in improving glucose clearance through completion of two objectives:

1. Identifying the concentration that lowers blood glucose and/or insulin concentration at an oral glucose tolerance test in healthy human participants.

2. Identifying if glucose disposal is mediated by changes in whole body insulin sensitivity.

Methods: 15 healthy participants were randomized in a double blind crossover design study to undergo an oral glucose tolerance test (OGTT) during saline or α-MSH infusion at three incremental doses (15,150,1500 ng/kg/hr) looking at the difference in glucose area under the curve (AUC). This was followed by euglycemic hyperinsulinaemic clamp study looking at the difference in glucose infusion rate (GIR) during saline vs. α-MSH infusion.

Results: A numerical non-significant reduction in glucose total AUC was observed with the middle and high doses of α-MSH in comparison to placebo. A trend towards increase in GIR during α-MSH infusion was noticed during the clamp procedure. No safety issues arose in this study.

Conclusions: In this first human study on α-MSH, we observed a trend towards improving glucose clearance in healthy participants with the high doses of α-MSH and hence results from future studies conducted on people with diabetes are eagerly awaiting.

source: https://www.endocrine-abstracts.org/ea/0077/ea0077P179.htm
 

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