Prolactin "minitherapy" with SMI-1 (novel protocol for lowering prolactin locally)

scientist_0005

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here you go @RolfLeeBuckler

"and most importantly a frontrunner asset HMI-115 that has got IND approval from the US FDA for Phase II clinical trial in endometriosis, and patient recruitment for the US Phase II clinical trial will start by Q4 of this year."

they have FDA approval for a clinical trial for the indication of "endometriosis". they do not have even FDA approval to conduct a trial in any other condition at this point in time.

just as i said, you do not develop such an expensive anti body for a condition that is not covered by insurance and while being underserved does really not have that much of a market potential. they will start clinical trial for the vagine condition soon. when will they start for AA? my guess is it will be the same as with Cassiopea where one product will be 5-6 years behind. now keep in mind that not every management is as aggressively incompetent as that shitty company from Italy but still, i would highly doubt that there will be a clinical phase 2 trial of this compound for the indication of AA before 2025. sad that hair loss is one again getting the short end of the stick but this is to be expected.


edit: the trial wont even start in Q4, recruitment will so add another 6 months on top of that time line. also multi center does not mean trial for multiple conditions, it just means in multiple institutes. really a bummer and i wish the drug would not work for the vagine disease
 
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scientist_0005

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actually in cancer clinical trials, people are literally fighting to secure a place in those trials. maybe not for prostate cancer but for stuff like glioblastoma where you have only a few months on average, every tiny bit of hope is enough to get someone to make big risks. the real downside is that you don not want to be in the placebo group and potentially miss out on real treatment that could prolong your life, that is the real reason holding people back. i really hope they are going to start the trial for AA soon as well for sure though. if they have gotten so much money, it is not out of this world to run two trials in parallel one might think. and as pegasus says, they once claimed to start them both so..
 

RolfLeeBuckler

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HMI has made it clear that the main reason they wanted the drug rights from Bayer was for the indication of Androgenetic Alopecia. They also confirmed Androgenetic Alopecia ph2 trials enrolling this year in Australia. It won't take 6 months to enroll patients with Androgenetic Alopecia. There are millions of bald men for them to choose from. It's not like trying to find a cancer patient that is willing to take a risk

Yes they wanted to Start in Summer or „later this year“ But they wont. Otherwise they would have written this in the article of 30.08.2021

It is so frustrating and dissapointing. They got 65 mio. $ and only do an endometriosis trial in US.
My hope is gone... :(
 

soull

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I don't understand how some people are disappointed with delays etc. We know how this industry works, we can't always be complaining because things don't go the way we want them to go. Use the forum as an information tool, if there is good and if not, then nothing and let's go on with our lives.
 

Gegen

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I don't understand how some people are disappointed with delays etc. We know how this industry works, we can't always be complaining because things don't go the way we want them to go. Use the forum as an information tool, if there is good and if not, then nothing and let's go on with our lives.
I'm still waiting muh SM04554's phase 3 results :mad:
 

soull

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I'm still waiting muh SM04554's phase 3 results :mad:
and I'm waiting for replicel to cure alopecia as it said it would in 2018..... o_Oo_O:D

I have also been visiting the forum since 2009, but this one and Stemson really caught my attention. I'm always cautious and don't get excited, but I think they may be on to something, time will tell....
 

Balding curse

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and I'm waiting for replicel to cure alopecia as it said it would in 2018..... o_Oo_O:D

I have also been visiting the forum since 2009, but this one and Stemson really caught my attention. I'm always cautious and don't get excited, but I think they may be on to something, time will tell....
It's weird that Brotzu lotion didn't caught your attention..

Does anyone remember that trials in Mexico?
 
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Throwaway94

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I see a lot of people participating in these group buys and after digging a bit into the science of it especially the paper published on the stump tailed monkeys that are a good animal model for androgenic alopecia i can understand the temptation at least some of it. however, prolactin and its effect on hair has been studied before has it not? there are no major publications that remotely indicate that it could have such potential. for every compaound ever trialed, i can understand the pathway and how exactly it might be involved in the pathology of AA. however, with this antibody, i get it the monkey have AA too but still... what is the theory behind this? how does it fit into the conventinally believed model of AA? I am sure someone has thrown in some idea in those 33 pages of thread but i can not read through that. I read quite some papers and some have found a suppression of anagen phase but only when prolactin in very high levels was used. which means that for a normal ranged guy, suppressing any signaling even further, how much is that going to profit them? no research on that at all.

I really hope, hopemed is going to trial this drug for AA. so far, they have only announced a trial for the other condition and i am afraid, it could go down like it did with companies of the likes of beloved cassiopea who took a literal decade to achieve a literal pile of nothing and they decided acne was their place to be and so totally neglected AA. I have a feeling this could be very similar with hopemed. what are the similarities? the vagina disease hopemed is trying to cure would also be covered by insurance, very convenient when you have an anti body that would probably cost thosuands of dollars in a prescription. for cassipea, this horse was acne. but we will see, hopefully very soon too
You're still too focused on serum prolactin levels. Also, why the f*** are you calling endometriosis "the vagina disease"? What's wrong with you?
 

Dimitri001

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I see a lot of people participating in these group buys and after digging a bit into the science of it especially the paper published on the stump tailed monkeys that are a good animal model for androgenic alopecia i can understand the temptation at least some of it. however, prolactin and its effect on hair has been studied before has it not? there are no major publications that remotely indicate that it could have such potential. for every compaound ever trialed, i can understand the pathway and how exactly it might be involved in the pathology of AA. however, with this antibody, i get it the monkey have AA too but still... what is the theory behind this? how does it fit into the conventinally believed model of AA? I am sure someone has thrown in some idea in those 33 pages of thread but i can not read through that. I read quite some papers and some have found a suppression of anagen phase but only when prolactin in very high levels was used. which means that for a normal ranged guy, suppressing any signaling even further, how much is that going to profit them? no research on that at all.

I really hope, hopemed is going to trial this drug for AA. so far, they have only announced a trial for the other condition and i am afraid, it could go down like it did with companies of the likes of beloved cassiopea who took a literal decade to achieve a literal pile of nothing and they decided acne was their place to be and so totally neglected AA. I have a feeling this could be very similar with hopemed. what are the similarities? the vagina disease hopemed is trying to cure would also be covered by insurance, very convenient when you have an anti body that would probably cost thosuands of dollars in a prescription. for cassipea, this horse was acne. but we will see, hopefully very soon too

I believe the theory is that it keeps stem cells dormant and not dividing? Don't know anything more detailed than that.

But what studies have you found on the effect of PRL on hair in humans?
 

Ollie

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I see a lot of people participating in these group buys and after digging a bit into the science of it especially the paper published on the stump tailed monkeys that are a good animal model for androgenic alopecia i can understand the temptation at least some of it. however, prolactin and its effect on hair has been studied before has it not? there are no major publications that remotely indicate that it could have such potential. for every compaound ever trialed, i can understand the pathway and how exactly it might be involved in the pathology of AA. however, with this antibody, i get it the monkey have AA too but still... what is the theory behind this? how does it fit into the conventinally believed model of AA? I am sure someone has thrown in some idea in those 33 pages of thread but i can not read through that. I read quite some papers and some have found a suppression of anagen phase but only when prolactin in very high levels was used. which means that for a normal ranged guy, suppressing any signaling even further, how much is that going to profit them? no research on that at all.

I really hope, hopemed is going to trial this drug for AA. so far, they have only announced a trial for the other condition and i am afraid, it could go down like it did with companies of the likes of beloved cassiopea who took a literal decade to achieve a literal pile of nothing and they decided acne was their place to be and so totally neglected AA. I have a feeling this could be very similar with hopemed. what are the similarities? the vagina disease hopemed is trying to cure would also be covered by insurance, very convenient when you have an anti body that would probably cost thosuands of dollars in a prescription. for cassipea, this horse was acne. but we will see, hopefully very soon too

dude the entire patent for HMI is aimed at androgen alopecia. The US is a nightmare covered in red tape - just because it doesn’t have approval there doesn’t mean it won’t be approved elsewhere. Not ideal but beggars can’t be choosers.
 

scientist_0005

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dude the entire patent for HMI is aimed at androgen alopecia. The US is a nightmare covered in red tape - just because it doesn’t have approval there doesn’t mean it won’t be approved elsewhere. Not ideal but beggars can’t be choosers.
yes but i am still looking to find a single paper that clearly links androgenic alopecia to the actions of prolactin. there are some on hyperprolactinemia in women who have levels way outside the normal range.

there is this paper


but i do not think it shows that prolactin is the driver of a pathological finding. sure, it may be implicated in inducing aptosis during the catagen phase but the Catagen phase is something that is a natural part of the hair cycle. there was some experiment where they treated hairs in vitro with prolactin and observed a reduced elongation of the hair shaft but the amount of prolactin they used was a multitude higher than what is normal for an average balding man. of course you would have to measure scalp prolactin and not serum prolactin as it is a auto/paracrine hormone and produced on site much like DHT. still, if this has had SUCH a tremendous effect in the non human primate model, it seems to me that this should have popped up in other research much more often?
 

scientist_0005

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There is no single paper finding that prolactin is THE cause of hair loss. There are lots of papers scattered throughout this thread and the Bayer thread that hint at its importance. If you don't want to read them, then please create your own thread to speculate on prolactin from a fresh start.
I just feel like if something produces results of such enormous proportions like in the macaque studies, this should be a central part of the theory no? after all targeting the androgen path way would never yield such results and yet thats the main theory rn. also this would have wide implications of the inner workings of stem cell biology as a whole?
 

Dimitri001

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I just feel like if something produces results of such enormous proportions like in the macaque studies, this should be a central part of the theory no? after all targeting the androgen path way would never yield such results and yet thats the main theory rn. also this would have wide implications of the inner workings of stem cell biology as a whole?
Because it's a new finding and probably a lot of people aren't even aware of it yet.
 

Ollie

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yes but i am still looking to find a single paper that clearly links androgenic alopecia to the actions of prolactin. there are some on hyperprolactinemia in women who have levels way outside the normal range.

there is this paper


but i do not think it shows that prolactin is the driver of a pathological finding. sure, it may be implicated in inducing aptosis during the catagen phase but the Catagen phase is something that is a natural part of the hair cycle. there was some experiment where they treated hairs in vitro with prolactin and observed a reduced elongation of the hair shaft but the amount of prolactin they used was a multitude higher than what is normal for an average balding man. of course you would have to measure scalp prolactin and not serum prolactin as it is a auto/paracrine hormone and produced on site much like DHT. still, if this has had SUCH a tremendous effect in the non human primate model, it seems to me that this should have popped up in other research much more often?

The problem is we don't understand the mechanism of action that prolactin has on hair follicles. I don't think there has been a single study of intrafollicular prolactin on hair growth, and we certainly don't know how much prolactin is required to interfere with the regrowth of hair.

It might be the case that the follicle is extremely sensitive to the presence of prolactin and even in minuscule doses prevents the recurrence of regrowth - which is why you need complete silencing of the PRLR from HMI for significant regrowth. All we can do currently is look at anecdotal evidence; Women during feeding following giving birth lose a lot of hair when prolactin levels are extremely high etc.

Rather than prolactin being responsible for miniaturisation process it might just be responsible for not allowing follicular regeneration.

Like with finasteride and minoxidil, both were discovered for hairloss by complete accident because of our lack of understanding of hair loss mechanisms and this is looking like a similar outcome.
 
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