Sm04554

[JayM]

Wasn't there another company who have come back to do scalp biopsies during phase 2? This could just be the natural progression of what they normally do. I mean we have never really seen a new experimental drug reach phase 3 so who knows?

[nameless]

I'm honestly confused. I think it's positive, because they're spending more money to get more data. But, why weren't they measuring these things in the first place? Why the need for additional studies?

I'm confused too but for different reasons. One thing that confuses me is why they need to do a study to count hair BULBS? Either their phase 2 showed new hair growth or it didn't. And why would they spend money on a special phase 2 if they didn't see new hairs in phase 2? I do not get it.

At any rate, the new study is 6 months long. I guess it will have to be completed before a phase 3 can be started. This special phase 2 completes in January 2016. Then the company and FDA will go through that information and this process could take 1 month or it could take numerous months. I figure that if it progresses to phase 3 the phase 3 will start somewhere between March 2016 and August 2016. It would complete in August 2017 and then it would take about 1 year (or longer) for FDA approval. It would hit the market about August 2018. If this stuff works were looking at a 3 year wait. Some people say we have located the patent while other people aren't as sure. Even the people who say we have isolated the patent say that there are 3 different compounds in the patent. If we can figure out for certain which drug it is then we could possibly get it made and avoid the 3 year wait.

[lacazette]

I hope it's a good sign

When I read again things like this, I really think SM will help us, even for miniaturized follicles

http://www.ncbi.nlm.nih.gov/pubmed/24750467

Modulating hair follicle size with Wnt10b/DKK1 during hair regeneration

"Here, we showed that in response to prolonged ectopic Wnt10b-mediated β-catenin activation, regenerating anagen hair follicles grew larger in size. In particular, the hair bulb, dermal papilla and hair shaft became enlarged

We observed dramatically enhanced proliferation within the matrix, DP and hair shaft of the enlarged AdWnt10b-treated hair follicles compared with those of normal hair follicles at P98. Furthermore, expression of CD34, a specific hair stem cell marker, was increased in its number to the bulge region after AdWnt10b treatment. Many CD34-positive hair stem cells were actively proliferating in AdWnt10b-induced hair follicles

Together, these findings strongly suggest that Wnt10b/DKK1 can modulate hair follicle size during hair regeneration

[It's2014ComeOnAlready]

One negative thing is that (if this drug works) this additional phase 2 will lengthen the timeline before it comes to market and so now if it works we will have to wait 4 years for it. All the more reason we should fund Hellouser's trip to the Congress under the condition that he will pursue interviews with the lead investigator (Wilma Bergfeld) and whatever Samumed staff-person that Samumed sends to the Congress so that he might secure information about which compound in the SM04554 is the correct drug.

Please don't stamp your own timelines on things, no one knows how long it's gonna take. This trial is only from July to January. The original trial goes until October, so that's an additional two months.

Also take into consideration the very likely passing of the 21st Century Cures Act, which has been planned to be passed before the year is out, and they haven't budged on that goal. If the law passes at the same time all the phase 2 trials are complete, with this additional data, it could speed things up.

[nameless]

I hope it's a good sign

When I read again things like this, I really think SM will help us, even for miniaturized follicles

http://www.ncbi.nlm.nih.gov/pubmed/24750467

Modulating hair follicle size with Wnt10b/DKK1 during hair regeneration

"Here, we showed that in response to prolonged ectopic Wnt10b-mediated β-catenin activation, regenerating anagen hair follicles grew larger in size. In particular, the hair bulb, dermal papilla and hair shaft became enlarged

We observed dramatically enhanced proliferation within the matrix, DP and hair shaft of the enlarged AdWnt10b-treated hair follicles compared with those of normal hair follicles at P98. Furthermore, expression of CD34, a specific hair stem cell marker, was increased in its number to the bulge region after AdWnt10b treatment. Many CD34-positive hair stem cells were actively proliferating in AdWnt10b-induced hair follicles

Together, these findings strongly suggest that Wnt10b/DKK1 can modulate hair follicle size during hair regeneration

Does SM04554 affect Wnt10b/DKK1?

I think someone posted that SM04554 affects Wnt3, but did not mention anything about Wnt10b/DKK1 or Wnt7a.

[nameless]

Please don't stamp your own timelines on things, no one knows how long it's gonna take. This trial is only from July to January. The original trial goes until October, so that's an additional two months.

Also take into consideration the very likely passing of the 21st Century Cures Act, which has been planned to be passed before the year is out, and they haven't budged on that goal. If the law passes at the same time all the phase 2 trials are complete, with this additional data, it could speed things up.

At the time I posted that it will take 4 years I did not know that the new phase 2 is only 6 months. Also, from October to end of January is about 3 - 4 months, not 2 months. Keep in mind that they will have to spend time assessing the data from the two phase 2 trials and then get the green light from the FDA to move to phase 3 before they can go to phase 3. When Samumed went from phase 1 to phase 2 there was an 8-month gap between the two studies.

Also, I do not think that the 21st Century Cures Act will have much of an affect on SM04554 for a number of reasons. Firstly, after an act is passed it takes a little while before it becomes law. Andby the time it becomes law SM04554 will have already completed all phase 2 trials anyway. Secondly, the law may allow the FDA to continue conducting things as the FDA in the past to allow the FDA time to adjust to the new law. Lastly, I have not heard anywhere that the 21st Century Cures Act would eliminate a need for a phase 3 trial for topically applied drugs. Are you saying that the 21st Century Cures Act could eliminate the need for a phase 3 study before a topically applied drug is approved? Please enlighten me.

I'm under the impression that the 21st Century Cures Act will have no effect on SM04554. If I'm wrong please enlighten me. I would love some good news.

[lacazette]

Does SM04554 affect Wnt10b/DKK1?

I think someone posted that SM04554 affects Wnt3, but did not mention anything about Wnt10b/DKK1 or Wnt7a.

I think it's linked as they are talking about modulating the Wnt pathway in general

in the study it's say "Therefore, it is possible that the WNT10b-induced canonical Wnt/β-catenin pathway could also directly promote proliferation and enlargement of the DP"

and in the SM patent they talk a lot about activation of Wnt/β-catenin pathway. Maybe the activation by Wnt3 or Wnt10b have nearly the same consequences when regarding the Wnt/β-catenin pathway
They also talk about DKK1 in the patent

[lacazette]

In the SM patent :

"With respect to hair loss, the canonical Wnt/β-catenin signaling pathway is known to regulate hair follicle development and regeneration
Wnt3α is secreted from hair epithelium and acts in an autocrine and paracrine fashion, and it has been demonstrated that Wnt-3α maintains anagen gene expression in dermal papilla cells and mediates hair-inductive activity in an organ culture. This Wnt-3α-mediated hair growth might depend on the canonical Wnt/β-catenin signaling pathway "

So it sounds like Wnt3a help to maintain anagen phase, and Wnt10 help to enlarge the hair follicle.

[nameless]

In the SM patent :

"With respect to hair loss, the canonical Wnt/β-catenin signaling pathway is known to regulate hair follicle development and regeneration
Wnt3α is secreted from hair epithelium and acts in an autocrine and paracrine fashion, and it has been demonstrated that Wnt-3α maintains anagen gene expression in dermal papilla cells and mediates hair-inductive activity in an organ culture. This Wnt-3α-mediated hair growth might depend on the canonical Wnt/β-catenin signaling pathway "

So it sounds like Wnt3a help to maintain anagen phase, and Wnt10 help to enlarge the hair follicle.

So then you might need both.

I do recall reading about a product that purportedly put Wnt10 into the scalp and the product is available.

[nameless]

Please don't stamp your own timelines on things, no one knows how long it's gonna take. This trial is only from July to January. The original trial goes until October, so that's an additional two months.

Also take into consideration the very likely passing of the 21st Century Cures Act, which has been planned to be passed before the year is out, and they haven't budged on that goal. If the law passes at the same time all the phase 2 trials are complete, with this additional data, it could speed things up.

I just read that the 21st century Cures Act would allow for drugs to come to market after a phase 2 study in cases of "groundbreaking" medicines. I wonder if this only applies to life-saving drugs??? I wonder if this could apply to a cosmetic drug????

[hellouser]

In the SM patent :

"With respect to hair loss, the canonical Wnt/β-catenin signaling pathway is known to regulate hair follicle development and regeneration
Wnt3α is secreted from hair epithelium and acts in an autocrine and paracrine fashion, and it has been demonstrated that Wnt-3α maintains anagen gene expression in dermal papilla cells and mediates hair-inductive activity in an organ culture. This Wnt-3α-mediated hair growth might depend on the canonical Wnt/β-catenin signaling pathway "

So it sounds like Wnt3a help to maintain anagen phase, and Wnt10 help to enlarge the hair follicle.

AFAIK, size of follicle is relative to thickness of hair. That's exactly what we need.

[It's2014ComeOnAlready]

At the time I posted that it will take 4 years I did not know that the new phase 2 is only 6 months. Also, from October to end of January is about 3 - 4 months, not 2 months. Keep in mind that they will have to spend time assessing the data from the two phase 2 trials and then get the green light from the FDA to move to phase 3 before they can go to phase 3. When Samumed went from phase 1 to phase 2 there was an 8-month gap between the two studies.

Also, I do not think that the 21st Century Cures Act will have much of an affect on SM04554 for a number of reasons. Firstly, after an act is passed it takes a little while before it becomes law. Andby the time it becomes law SM04554 will have already completed all phase 2 trials anyway. Secondly, the law may allow the FDA to continue conducting things as the FDA in the past to allow the FDA time to adjust to the new law. Lastly, I have not heard anywhere that the 21st Century Cures Act would eliminate a need for a phase 3 trial for topically applied drugs. Are you saying that the 21st Century Cures Act could eliminate the need for a phase 3 study before a topically applied drug is approved? Please enlighten me.

I'm under the impression that the 21st Century Cures Act will have no effect on SM04554. If I'm wrong please enlighten me. I would love some good news.

We're gonna have to get you a "jump to conclusions" mat.

Anyway, how many months are between October and January? Two. They are November and December. Also, it doesn't show anywhere that it's the "end of January."

The 21st Century Cures Act speeds up the development process of drugs in many ways. Nobody can say for sure what effect it will have on any trials. But if by law, the drug process is streamlined, and they are allowed to use biomarkers and surrogate endpoints for primary outcome measures, then it is likely that it will help.

[nameless]

We're gonna have to get you a "jump to conclusions" mat.

Anyway, how many months are between October and January? Two. They are November and December. Also, it doesn't show anywhere that it's the "end of January."

The 21st Century Cures Act speeds up the development process of drugs in many ways. Nobody can say for sure what effect it will have on any trials. But if by law, the drug process is streamlined, and they are allowed to use biomarkers and surrogate endpoints for primary outcome measures, then it is likely that it will help.

LOL! For all you know the present phase 2 ends in early October and the special phase 2 ends in late January. You don't know. You're guessing. You're assuming the most favorable scenario because that's what you want to happen, but right now you don't know. And you should always plan for the worse. You should hope for the best but plan for the worse. The bottom line that the new study is somewhere between 2 and 4 months from the present study.

[lacazette]

Damn, I can't wait til november héhé I really want to know what kind of results this drug could give.
It's the first one who play with the wnt pathway modulating, and this way seems far more powerful in the studies than simply anti androgens shit,etc.
So who knows, it could be quite a cure in combination with a big HT, even for big Norwoods

[nameless]

I think it's linked as they are talking about modulating the Wnt pathway in general

in the study it's say "Therefore, it is possible that the WNT10b-induced canonical Wnt/β-catenin pathway could also directly promote proliferation and enlargement of the DP"

and in the SM patent they talk a lot about activation of Wnt/β-catenin pathway. Maybe the activation by Wnt3 or Wnt10b have nearly the same consequences when regarding the Wnt/β-catenin pathway
They also talk about DKK1 in the patent

Why would they even mention the Wnt10 pathway if the drug (SM04554) has no effect on the Wnt10 pathway?