SM04554 Phase 2 results

[Bad_Wolve]

No way. This company completed phase II in like a year and a half. There's no way they would wait until 2018-2019 to release this when replicel and histogen are supposed to come out around then; I think replicel and histogen are our biggest hopes. If they fail then we are ****ed

im sorry mate, histogen is just a comb over treatment. their before after pics are crap. replicel´s stocks are decreasing, i think their trial in germany is also canceled. i have no hope in this two. sm can be the first treatment available on market since minoxidil and finasteride. lets hope that they have good results, so we could hold our hair loss with kerastem for example, which is available on many sites yet.

 

[Pavi]

I'm not going to get into an argument and won't post in this thread again until the conference, but do you think the product is just going to appear on shelves if/when phase III is complete? There's more to releasing a product than just the clinical trials. Yes, Samumed has moved fast, but we don't know when the final trial might start, what goes into producing the drug, etc. As for Replicel and Histogen - if Samumed has promising results, they're not waiting around for either of those companies when both have taken years and years to progress. Replicel has faced delay after delay, and the 2018 target is for Japan anyway (and Histogen would be released in Mexico first, ideally). I'm not holding my breath for either.
All I'll say is, expect to be ****ed if you're holding your breath for either of those.

So what are you looking forward to?

 

[hellouser]

im sorry mate, histogen is just a comb over treatment. their before after pics are crap. replicel´s stocks are decreasing, i think their trial in germany is also canceled. i have no hope in this two. sm can be the first treatment available on market since minoxidil and finasteride. lets hope that they have good results, so we could hold our hair loss with kerastem for example, which is available on many sites yet.

This is false.

 

[wilson2]

would this be compatible with Minoxidil. (sorry for the easy question, i've been really busy with work and can't do much research lately)

 

[buckthorn]

I don't know how you can already make the generalization that histogen is a "comb over treatment".. 1) some of the photo evidence is far from combover. You can see terminal hair growth where there was NO hair at all and 2) if they can tweak their protocol even further, this could be a serious game changer. I am not saying you can be NW7 and regrow all your hair, but for us diffuse thinners, it could go a long way.

 

[Tracksterderm]

It's funny how everybody starts to speculate on how effective it is based on that they are presenting at this conference and are first up non-the-less

They did already say it did increase hair growth and density. It will be exciting to see what they mean by significant. And would be awesome if it was with pictures and not just numbers or graphs.

 

[Folliman]

Yes
My hair will be like:
[video=youtube;I2Cm4Cy3rxs]https://www.youtube.com/watch?v=I2Cm4Cy3rxs[/video]

I've been trying to find this movie for years!

 

[buckthorn]

I am in a position to attend. What is the cost? And would I have to spend the entire day? Let me know exactly which presentations are worth my time, exactly when they begin, and how long they will be (I don't feel like combing through the details, no pun intended), and I will consider it.

I think it's like $2,200 to attend

 

[Dench57]

I assume these results will be released publicly? The presentation is only 12 minutes and will probably just be a poster...

 

[I.D WALKER]

There better be an open bar after that charge.

I think it's like $2,200 to attend

 

[hellouser]

I think it's like $2,200 to attend

Holy crap. Are you serious? We only need info from the one presentation. I don't think there's anything else of interest for us from this event.

- - - Updated - - -

I assume these results will be released publicly? The presentation is only 12 minutes and will probably just be a poster...

If there's a poster, there's a chance you may not need to pay at all. At the hair congress in Abilene, they only checked for ID badges for presentations at the venue. The posters were essentially open to the public.

 

[I.D WALKER]

Sit this one out.
A 12 minute presentation at 2g's is tomfoolery and they can suck a duck.

 

[Swoop]

No sense in speculation now really as we'll have results soon guys..

Nonetheless a bit of hair follicle biology;

In late telogen (resting phase) before the anagen phase dermal papilla cells activate WNT signalling. There is a point of "no return" and this occurs when secondary hair germ cells turn on WNT signalling and start to proliferate. Voila, anagen initiation. Obviously there is a plethora of complex signalling occurring in between, but WNT does play a very central role in telogen to anagen transition.

Huh? So modulating WNT should be our cure right?

False, it's not that easy. The above explanation is only in a healthy hair follicle cycle.

In fact and I quote;

It has long been known that rodent skin with all HFs in telogen is exquisitely sensitive to a diverse range of anagen-inducing stimuli. These include trauma (e.g. by hair shaft depilation) (Chase, Montagna & Malone, 1953; Chase, 1954; Argyris & Trimble, 1964; Paus et al., 1990), immunosuppressive immunophilin ligands (Paus et al., 1989, 1996; Horsley et al., 2008), signals such as selected prostaglandins and cytokines (Paus et al., 1994, 1995; Stenn & Paus, 2001; Blume-Peytavi et al., 2012; Garza et al., 2012; Nieves & Garza, 2014), and neuropeptides such as substance P and adrenocorticotropin hormone (ACTH) (Paus et al., 2005; Schneider et al., 2009; Paus et al., 2014). The discovery of ‘competent telogen’ (Plikus et al., 2008) (Fig. 3), and the stepwise elucidation of molecular changes in the telogen HF’s signalling milieu that prepare it for entry into anagen, have provided a rational basis for explaining why it is so easy to induce anagen in defined subpopulations of telogen HFs, and by such divergent stimuli. This recent progress also helps to explain why

Yes guys, it's easy to induce anagen in healthy hair follicles which are sitting in telogen. It's easy as hell. In fact I put many treatments into that route. Indeed, even prostaglandins are known to do this since a long goddamn time. As such PGF2A for instance works good on the eyebrows for example. Why? Because it most likely modulates the hair follicle cycle. The hairs there are different from scalp hair (way shorter anagen phase and longer telogen phase and higher telogen %). Thus PGF2A most likely modulates this by extending anagen and shifting more hair follicles into the anagen phase from telogen. Resulting in more and thicker and longer hair. Simply because much resting hair follicles are prompted into anagen and subsequently the hair follicles have a longer time to grow before they fall out. Basically competent telogen hair follicles sit in a sort of equilibrium between growth arrest and proliferation.

But this is no art boys.. Bottom line is around 8-15% of hair follicles are sitting in telogen on your scalp. In Androgenetic Alopecia however telogen gets longer and also shifts to a more telogen %. But modulation of the hair follicle cycle is not what we want. We want something that saviors those miniaturized hair follicles which are in some sort of permanent arrest!

Androgenetic Alopecia is dominating us all thus far guys, pray to the hair gods

. It's time for better treatments!

 

[Tracksterderm]

No sense in speculation now really as we'll have results soon guys..

Nonetheless a bit of hair follicle biology;

In late telogen (resting phase) before the anagen phase dermal papilla cells activate WNT signalling. There is a point of "no return" and this occurs when secondary hair germ cells turn on WNT signalling and start to proliferate. Voila, anagen initiation. Obviously there is a plethora of complex signalling occurring in between, but WNT does play a very central role in telogen to anagen transition.

Huh? So modulating WNT should be our cure right?

False, it's not that easy. The above explanation is only in a healthy hair follicle cycle.

In fact and I quote;



Yes guys, it's easy to induce anagen in healthy hair follicles which are sitting in telogen. It's easy as hell. In fact I put many treatments into that route. Indeed, even prostaglandins are known to do this since a long goddamn time. As such PGF2A for instance works good on the eyebrows for example. Why? Because it most likely modulates the hair follicle cycle. The hairs there are different from scalp hair (way shorter anagen phase and longer telogen phase and higher telogen %). Thus PGF2A most likely modulates this by extending anagen and shifting more hair follicles into the anagen phase from telogen. Resulting in more and thicker and longer hair. Simply because much resting hair follicles are prompted into anagen and subsequently the hair follicles have a longer time to grow before they fall out. Basically competent telogen hair follicles sit in a sort of equilibrium between growth arrest and proliferation.

But this is no art boys.. Bottom line is around 8-15% of hair follicles are sitting in telogen on your scalp. In Androgenetic Alopecia however telogen gets longer and also shifts to a more telogen %. But modulation of the hair follicle cycle is not what we want. We want something that saviors those miniaturized hair follicles which are in some sort of permanent arrest!

Androgenetic Alopecia is dominating us all thus far guys, pray to the hair gods

. It's time for better treatments!

But in their announcement they said the product "generates new hair follicles".

 

[Swoop]

But in their announcement they said the product "generates new hair follicles".

Actual morphogenesis? Creation of new hair follicles?

This has NEVER, I repeat, NEVER been demonstrated outside rodent models. So if someone says that they must deliver proof. Always ask for actual proof if someone claims anything. As genius Einstein once said;

Blind belief in authority is the greatest enemy of truth.

Bottom line is if they can do that we'll surely get proof of that. But it's not true until proven otherwise.

 

[Tracksterderm]

Actual morphogenesis? Creation of new hair follicles?

This has NEVER, I repeat, NEVER been demonstrated outside rodent models. So if someone says that they must deliver proof. Always ask for actual proof if someone claims anything. As genius Einstein once said;



Bottom line is if they can do that we'll surely get proof of that. But it's not true until proven otherwise.

I agree about not believing it just because they say so, but I'm just stating that what was in the statement. Could have been worded wrong in the statement or whatever, but if that's the case it is not just about WNT signalling and extending the anagen phase.

I am excited to hear what they have to say even though I am sceptical to the safety of the whole thing, having been in trials for a relatively short amount of time.

 

[paleocapa89]

Although I am skeptical about the 'brand new' follicles, I do hope that Samumed is capable more than just initiating the anagen cycle. After all, this is what they claim about the Wnt pathway:

"One of the primary signaling pathways that regulate the self-renewal and differentiation of adult stem cells is the Wnt pathway, a term which refers to a group of signal transduction pathways that play a crucial role in tissue health, ranging from formation to replenishment and from repair to regeneration of various tissues."

I guess we'll have to wait and see..

 

[lynney45]

I wonder why they haven't launched trials in Japan to speed up time to market, as phase ii has finished now they could have been releasing in Japan imminently

 

[Chrisolution]

Lets say everything works out great. Phase II was impressive. How long does Phase III take in US before it hits market?

 

[Pavi]

Lets say everything works out great. Phase II was impressive. How long does Phase III take in US before it hits market?

1~3 years