Sm04554 Update To Follow! Encouraging. News Release
- Thread starter Tomtom21
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Nice. I almost forgot about Samumed. It's pretty awesome that there are so many different potential treatments with real science behind them.
If it is as they say, "new hair follicles", then I wonder how good the statistically significant data is after 135 days as the had for this trial. The previous phase 2 trial showed around 10%(?) increase. So the result should just keep improving with new HF.
If it is as they say, "new hair follicles", then I wonder how good the statistically significant data is after 135 days as the had for this trial. The previous phase 2 trial showed around 10%(?) increase. So the result should just keep improving with new HF.
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Found an article today talking about Samumed, I'll try and post a link, but last time I tried it wouldn't let me! Quote below for the part that peeked my interest.
http://magazine.pomona.edu/2016/fall/how-to-build-a-fountain-of-youth-piece-by-piece/
'The FDA is the gatekeeper, and though less than 10% of proposed new drugs ultimately earn FDA approval, the likelihood increases with each step forward in the lengthy process. The next step for Samumed’s most advanced projects, the hair loss and osteoarthritis drugs, is large Phase III studies with thousands of participants. Some 64% of drugs that begin Phase III studies are submitted for FDA approval and 90% of those are successful, according to a study cited by the independent site fdareview.org.'
Might not mean anything cause the next logical step is a phase III and they're just assuming here, but it was only posted on the 25th, the same day as the release Samumed put out, so maybe there's something.
For those that can't see the original link:
'October 25, 2016 Samumed Successfully Completes a Phase II Androgenetic Alopecia (“Androgenetic Alopecia”) Biopsy Trial Studying Regeneration of Hair Follicles San Diego, CA – Samumed, LLC successfully completed a 135-day study of its topical compound, SM04554, on 49 male subjects with Androgenetic Alopecia analyzed by biopsy of the scalp prior to and post dosing. The safety and the efficacy results of this second Phase II Trial further support the safety and efficacy findings from the company’s prior trials. Moreover, the biopsy results support the program’s mechanism-of-action regarding new hair follicle regeneration. As the Company previously reported, efficacy data from its first Phase II Androgenetic Alopecia trial showed statistically significant increases for both objective outcome measures: non‐vellus hair count (a primary outcome measure) and hair density (a secondary outcome measure), using the pre‐specified statistical model. Further, in that first Phase II Androgenetic Alopecia study, there were no serious adverse events observed in any treated patient, and the incidence of adverse events was similar between treatment and vehicle groups. The Phase II Androgenetic Alopecia Biopsy study results will be presented at upcoming medical conferences.'
http://magazine.pomona.edu/2016/fall/how-to-build-a-fountain-of-youth-piece-by-piece/
'The FDA is the gatekeeper, and though less than 10% of proposed new drugs ultimately earn FDA approval, the likelihood increases with each step forward in the lengthy process. The next step for Samumed’s most advanced projects, the hair loss and osteoarthritis drugs, is large Phase III studies with thousands of participants. Some 64% of drugs that begin Phase III studies are submitted for FDA approval and 90% of those are successful, according to a study cited by the independent site fdareview.org.'
Might not mean anything cause the next logical step is a phase III and they're just assuming here, but it was only posted on the 25th, the same day as the release Samumed put out, so maybe there's something.
For those that can't see the original link:
'October 25, 2016 Samumed Successfully Completes a Phase II Androgenetic Alopecia (“Androgenetic Alopecia”) Biopsy Trial Studying Regeneration of Hair Follicles San Diego, CA – Samumed, LLC successfully completed a 135-day study of its topical compound, SM04554, on 49 male subjects with Androgenetic Alopecia analyzed by biopsy of the scalp prior to and post dosing. The safety and the efficacy results of this second Phase II Trial further support the safety and efficacy findings from the company’s prior trials. Moreover, the biopsy results support the program’s mechanism-of-action regarding new hair follicle regeneration. As the Company previously reported, efficacy data from its first Phase II Androgenetic Alopecia trial showed statistically significant increases for both objective outcome measures: non‐vellus hair count (a primary outcome measure) and hair density (a secondary outcome measure), using the pre‐specified statistical model. Further, in that first Phase II Androgenetic Alopecia study, there were no serious adverse events observed in any treated patient, and the incidence of adverse events was similar between treatment and vehicle groups. The Phase II Androgenetic Alopecia Biopsy study results will be presented at upcoming medical conferences.'
RatherGoBlindThanSeeItGo
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This is pretty big imo. I have never been too excited about Samumed because they seem less active somehow, and having a potentially effective lotion years away sounds less exciting than having the occasional injection (Histogen) or even a one-time fix treatment (Replicel). Even Brotzu is claiming to be more effective than samumed and it doesn't even need large scale clinical trials to please the FDA. But this piece of news makes me take Samumed a bit more seriously. The more baskets to collectively put our eggheads in, the better.
10% increase in hair count if I remember correctly. However if their biopsy shows that those are indeed NEW hair follicles then that changes things.
It is still not much however coupled with something else the Big 3 might become something else.
Lets just say my expectations are low but I'm gonna keep watching them.
The question now is when are they starting Phase3?
Everyone should know that for example Breezula should finish Phase 2 in 2017 or 2018. but they are gonna start Phase 3 in 2021. That means sometimes there could be a 3 year gap between Phase 2 and 3.
It is still not much however coupled with something else the Big 3 might become something else.
Lets just say my expectations are low but I'm gonna keep watching them.
The question now is when are they starting Phase3?
Everyone should know that for example Breezula should finish Phase 2 in 2017 or 2018. but they are gonna start Phase 3 in 2021. That means sometimes there could be a 3 year gap between Phase 2 and 3.
Breyfogle
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Their first Phase II trial, which was completed last March, showed results slightly better than Minoxidil.
I personally think that's great for a phase II. Phase III research should further up the results.
Plus, minoxidil stops working over time. They say SM generates new follicles, so I suspect it actually gets better over time.
I personally think that's great for a phase II. Phase III research should further up the results.
Plus, minoxidil stops working over time. They say SM generates new follicles, so I suspect it actually gets better over time.
Noisette
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The results will be presented at Forbes Healthcare Summit, November 30-December 1, 2016
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Do you have to apply it on a daily basis? for a reason I don't know, I thought it was a one shot.
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As far as I'm aware its a topical.
My understanding is, that Samumeds drugs are designed to regenerate cells. This means, it would or should "heal" your miniaturized follicles and return them into a "pre bald" state. However, this does not mean that the "healed" follicles are immune to DHT.
Lets assume you've started losing your hair at 26. Therefore your "weakest native hair follicles" can tolerate about 10 years of DHT before it begins to shrink noticeably. So the SM-regenerated hairs would have at least another 10 years before falling out again.
As mentoined above - this is my understanding on how it's supposed to work. Might completly worng...
On the other hand the press release says:
"Moreover, the biopsy results support the program’s mechanism-of-action regarding new hair follicle regeneration."
I don't really get the meaning of this. Don't you either regenerate a [damaged] hair follicle or create a new one?
Okay the reason I find SM04554 so tantalizing is actually quite simple. If we refer back to Cotsarellis presentation from 8th WHC, he discusses that hair follicle stem cell populations are actually still present just not actively proliferating and differentiating into progenitor cells. Samumed through the wnt pathway aims to replenish and regenerate the progenitor cell population. I think if you watch cots presentation from 2014 then watch samumeds presentation from RMS you'd get pretty excited as well.