Sm04554

[nameless]

What are the possible reasons for why Samumed is doing the supplemental phase 2 for SM04554?

I see 2 possibilities:

1. The drug did not grow hair in the original phase 2 so they want to dig into the skin with biopsies to find out why?


2. The drug did grow hair so Samumed wants to collect as much data as possible to give to the FDA to increase the likelihood of the drug being approved. And Samumed may even be hoping that the FDA will allow the drug to come to market after completing phase 2 if the new 20th Century Cures Act passes and if Samumed can give the FDA enough info to satisfy the FDA by doing a detailed supplemental phase 2 with biopsies.

[lacazette]

Any info , just a new website design in 2015. I think I see that he will be at the hair congress.

[lacazette]

Wnt/β-catenin signaling in dermal condensates is required for hair follicle formation.

http://www.ncbi.nlm.nih.gov/pubmed/24309208

"In summary, these data reveal a functional role of Wnt signaling in DP precursors for embryonic hair follicle formation"


@Nameless, I think one of these two is more designed to assess dosing, and the other one is more designed to determine efficacy (like other clinical trials "phase 2a, 2b")

[nameless]

Wnt/β-catenin signaling in dermal condensates is required for hair follicle formation.

http://www.ncbi.nlm.nih.gov/pubmed/24309208

"In summary, these data reveal a functional role of Wnt signaling in DP precursors for embryonic hair follicle formation"


@Nameless, I think one of these two is more designed to assess dosing, and the other one is more designed to determine efficacy (like other clinical trials "phase 2a, 2b")

The more I think about it the more it looks to me like Samumed believes that the 21st Century Cures Act will pass and they're planning to ask for FDA approval after phase 2.

One of the big changes in the act is that the FDA will be allowed to use
biomarkers in the decision-making process whether or not to approve a drug.
Biopsies produce biomarkers and Samumed is doing scalp biopsies. So this extra phase
2 study that Samumed is doing is the exact kind of study they would have to do in order to secure early approval after phase 2.

[Parsia]

Hello Bro , Thanks for your clarification .

I used lipogaine minoxidil and also lipogaine shampo , I can say I've got cover almost all my crown and on top of my head. in frontal I've got

not that much regrowth but thickness for sure.

My result and pics on hairloss talk forum but you need to have account there to see them , if you like I can post it to you.

I'm adding few more options for get more regrowth recently

[nameless]

I think that Samumed is probably trying to eliminate the phase 3 trial and go straight from phase 2 to the market-place.

One of the specifics of the 21st Century Cures Act is that the phase 3 study can be eliminated and replaced by doing biomarkers instead. Samumed initiated an extra phase 2 out of the clear blue and this extra phase 2 involves biopsies. I think
that biopsies produce biomarkers. I think that they may intend to use the biomarkers from the extra phase 2 study as a replacement for a phase 3 trial.

Here's an article that shows that biomarkers can replace the phase 3 study if the
21st Century Cures Act becomes law:

http://moderndayms.com/2015/07/u-s-house-of-representatives-passes-the-21st-century-cures-act/

[dus]

The more I think about it the more it looks to me like Samumed believes that the 21st Century Cures Act will pass and they're planning to ask for FDA approval after phase 2.

One of the big changes in the act is that the FDA will be allowed to use
biomarkers in the decision-making process whether or not to approve a drug.
Biopsies produce biomarkers and Samumed is doing scalp biopsies. So this extra phase
2 study that Samumed is doing is the exact kind of study they would have to do in order to secure early approval after phase 2.

Wow, this could be really good... must. not. get. my. hopes. up. Anyway we would need an airbridge to us European baldies if it becomes available in the US.

[lacazette]

2014 β-Catenin activation regulates tissue growth non-cell autonomously in the hair stem cell niche

http://www.ncbi.nlm.nih.gov/pubmed/24653033

"Wnt/β-catenin signaling is critical for tissue regeneration."

"β-Catenin activation is sufficient to induce hair growth independently of mesenchymal dermal papilla niche signals normally required for hair regeneration"

The more I search, the more I strongly believe in SM
I've seen almost 30 studies that explained in details and determined exactly how B catenin activation plays a major crucial role for hair, and 90% of these studies are from the period 2013-2015
SAMUMED are the pionner in this area and hopefully a winner

I repost this quote that makes me dream (comes from a 2014 study of a japanese lab that work on tissue regeneration (in the same center where there is the Tsuji lab)

"Wnt/β-catenin signaling in keratinocytes is activated by topical application of 4-hydroxytamoxifen (4OHT) to mouse dorsal skin. A single application to telogen skin is sufficient to stimulate anagen, whereas six treatments not only stimulate anagen of existing follicles but also induce ECTOPIC HF formation as a result of expansion of the epidermal stem cell compartment and reprogramming cells in the sebaceous gland and interfollicular epidermis to differentiate along the hair follicle lineages (9). "

If B catenin activation can (not only induce anagen phase, make the existing HFs stronger and bigger, wake up the dormant ones), but can also grow NEW HF from existing ones, then I think we are almost saved! (maybe in combination with an ht for Norwoods 5/7) (and still with an anti DHT treatment to help these new follicles to achieve full growth without something that try to kill them hehe)

Now my biggest fear is that someone in the trial develop cancer, it would mean many other years of trial or even cancellation . So let's pray everything goes well, cause this drug is damn promising

A last one "Wnt/β-catenin signaling controls multiple aspects of skin epithelial regeneration, with its excessive activity promoting the hyperactivation of hair follicle stem/progenitor cells

[lacazette]

Nov 2014

http://jcb.rupress.org/content/207/4/549.full

Here, we show that miR-214 regulates skin morphogenesis and hair follicle (HF) cycling by targeting β-catenin, a key component of the Wnt signaling pathway. miR-214 exhibits differential expression patterns in the skin epithelium, and its inducible overexpression in keratinocytes inhibited proliferation, which resulted in formation of fewer HFs with decreased hair bulb size and thinner hair production. The inhibitory effects of miR-214 on HF development and cycling were associated with altered activities of multiple signaling pathways, including decreased expression of key Wnt signaling mediators β-catenin and Lef-1, and were rescued by treatment with pharmacological Wnt activators."

[nameless]

lacazette, I think that biopsies produce bio-markers. Doesn't it seem striking that Samumed is doing a biopsy/bio-marker phase 2 study at a time when a legislative act, favored to become law, allows drug companies to use bio-markers in lieu of Phase 3 studies? Check out this link and scroll down to "part 2."

http://moderndayms.com/2015/07/u-s-house-of-representatives-passes-the-21st-century-cures-act/

[lacazette]

Damn! you are right my friend, it's a clear possibility

I wasn't aware of that! I was believing that elimination of phase 3 would be ONLY for rare and serious diseases but I was wrong! thank you dude you made my day

its also said here :

http://www.collective-evolution.com/2015/07/07/the-21st-century-cures-act-is-on-its-way-heres-why-you-havent-heard-about-it/

"The 21st Century Cures Act allows drugs to be rushed to the market, removes phase 3 testing as a requirement for drug approval, bases drug approval on biomarkers rather than actual health outcomes"

And here:

http://www.raps.org/Regulatory-Focus/News/2015/04/30/21192/Regulatory-Explainer-The-Updated-21st-Century-Cures-Act/

Subtitle B of Title II is slightly modified from the original draft of the legislation. It remains focused on the "qualification and use of drug development Tools
"The development of biomarkers and other drug development tools can benefit the availability of new medical therapies by helping translate scientific discoveries into clinical applications," the bill explains

Section 2022 of the draft legislation would amend federal law to facilitate accelerated approvals—approvals based on surrogate (e.g. intermediate) endpoints intended to serve as evidence that a drug would be effective in a population. FDA has long relied on surrogate endpoints to support accelerated approvals, but only for drugs intended to treat patients with life-threatening illnesses and unmet needs.The legislation would require FDA and a sponsor to enter into an "accelerated approval development plan" (AADP) similar in concept to a special protocol assessment (SPA). The AADP would establish the minimum data parameters which, if met, would support the approval of a drug using surrogate endpoints.


And from your link:

"This part of the bill allows drugs to get to the consumer quicker. This is because Phase 3 testing has been eliminated
The new method replacing Phase 3 testing bases drug approvals on biomarkers, the way living cells react to specific things introduced to those cells


The real world effects of this Act are still unknown but the central point of contention is singularly rooted in the increased freedom and lack of oversight of pharmaceutical companies."


Sounds too good to be true x)
Im not aware of us, when do this bill will defenitly be adopted? Is there obstacles to come or can we say that it's just a matter of time?

[It's2014ComeOnAlready]

It definitely seems like it's only a matter of time. There is too much support, politically, from the majority of health organizations, universities etc.

beta-catenin expression is a biomarker, KI-67 expression is a biomarker, also having data on how those correlate to the outcomes of increased hair growth will be important.

There is a lot to be positive about here. Hopefully the 21st Century Cures Act makes a difference in the speed of future trials.

Each of these drugs - SM, Seti, Bim (if it's not launched soon) are primed to be approved much sooner than later under these new laws.

[Illusion]

SM really is the only thing I'm looking forward to, the science behind it is just so solid... Dus makes a fair point though, would that 21st century law mean that it could only be approved much earlier in the USA? Or would it be approved at the same time in Europe as well? Forgive my ignorance but I have no idea how all this regulation stuff works.

[nameless]

The 21st Century Cures Act has passed the house and now it's in the US Senate. I just sent messages to both of my US Senators asking them to support the 21st Century Cures Act - especially the part that allows the use of bio-markers instead of the phase 3 trial.

[champpy]

I haven't actually gone over any of the studies so forgive my ignorance...While a lot of these quotes from the studies sound great, please tell me that this has been tested on more than mice and rats?