Sm04554

[It's2014ComeOnAlready]

The more I think about it, the more the use of biomarkers for phase 3 trials makes terrific sense. Most drugs never even reach phase 3. If they've shown definite safety and effectiveness in phases 1 & 2, and if there are biomarker(s) that can determine whether or not a drug is actually having an effect on its target, then that is much more common sense than what the current rules are.

Phase 3 trials are the most expensive to run due to their size, duration etc. If a company cannot continue to fund a drug that is safe, effective, and could otherwise prove that it is a targeted therapy, then all the FDA is doing in this case is stifling innovation.

For these reasons, I also believe a drug like setipiprant, which has already had a phase 3, will also be sped up. They would only need to determine whether or not the drug is reducing PGD2 levels in the scalp, along with scalp biopsies to determine the change in the number of hairs in an anagen state.

I don't believe in God, but God bless the politicians, medical professionals, and venture capitalists who are responsible for this bill lol

[JayM]

Is there a date it has to be passed into law/not passed by?

[lacazette]

Look at this:

Angela Christiano, Ph.D.

Hair-Loss Treatment with Hair-Loss Gene Promotes New Hair Growth, Regulates Male-Pattern Baldness

The discovery of the APCDD1 gene, which causes hair loss, has potential for future male-pattern baldness treatments, and for regulating male and female hair growth, density of hair, and hair graying.

the APCDD1 gene inhibits the Wnt signaling pathway

Laboratory researchers have targeted this Wnt pathway to turn on or off hair growth in mice, but until now, the pathway did not appear to be involved in human hair loss. Their findings provide evidence that hair-growth patterns in humans and in mice are similar, and they suggest for the first time that manipulating the Wnt pathway may have an effect on human hair-follicle growth.

Unlike commonly available hair loss treatments that involve blocking hormonal pathways, treatments involving modulation of the APCDD1 gene and the Wnt pathway would be non-hormonal, which may enable many more people suffering from hair loss to receive such therapies

Advantages:
•Surgical treatment options for hair loss require multiple costly procedures. This technology represents a way to modulate hair growth without the need of surgery as APCDD1 represents a potential drug target.
•Targeting APCDD1 will not only prevent further hair loss but has the potential to grow new hair, in contrast to current medical alternatives.
"

http://innovation.columbia.edu/techn...d-graying-hair

So it's seems there's two ways: inhibit APCDD1
or upregulate the pathway that is inhibited by this gene ( samumed )

Samumed patented their Wnt pathway activators in 2011 http://www.google.com.na/patents/EP2605652A1?cl=un

[seanway]

So how to fight APCDD1 ? sm04554 ?

[lacazette]

It's been 4 years, so I think she didn't found for the moment a topically safely way to inhibit this gene with a molecule

Whereas samumed have the safely molecule to activate the wnt pathway

So yes I think SM04554 will make our Wnt signaling pathway come back to his normal activity. The gene inhibit the pathway but we will upregulate this pathway daily. So I really think that SM will stop (or slow for years) the hair loss, and even more activation will give regrowth. But abberant activation give skin cancer, so they have to be careful.
But our Wnt signaling pathway is inhibited right now, so we just need an upregulation that lead to his normal activity, so it's far from cancer aberrant activity i think

[seanway]

But if we use something topically with low half life it should be a matter of concern isnt ? I hope SM04554 will have nice result.

[lacazette]

Well they used it once daily in the trials, so let's hope their level activation is strong enough. Maybe severe hair loss sufferers will be able to use it twice daily ^^

In mouse just one topical Wnt activation induced anagen phase of the HFs, whereas 6 applications not only induce anagen phase, but also lead to ectopic HF formation from existing ones.


another study mentioning Wnt, 2014

The Wnt/β-catenin pathway plays an important role in the initiation, development, and growth of hair follicles.
The transient activation of β-catenin results in hair regrowth in mice, while ablation of β-catenin results in dramatic hair shortening and abnormal regeneration of hair in the dermal papilla of mouse hair follicles [19, 33]. The levels of β-catenin in the dermal papilla are high in the anagen phase but low in the catagen and the telogen phases [18, 34]. Furthermore, the interaction between β-catenin, androgen receptors, and keratinocyte growth inhibition through modification of Wnt signaling contributes to androgenic alopecia, a common form of hair loss

[champpy]

I read earlier in this thread that Samumed is the 3rd largest sponsor of the Hair Conference. Can anyone tell me if this is their first time as a sponsor? Also, who are the other two sponsors that are ahead of Samumed?

If this is their first time, and they have a large presence, this tells me that they may actually have something they want to announce.

[xyz123]

I read earlier in this thread that Samumed is the 3rd largest sponsor of the Hair Conference. Can anyone tell me if this is their first time as a sponsor? Also, who are the other two sponsors that are ahead of Samumed?

If this is their first time, and they have a large presence, this tells me that they may actually have something they want to announce.

First time they've been a sponsor. And Women's Rogaine and Procter & Gamble are the top 2.

http://www.hair2015.org/

[nameless]

We should be contacting our US senators and asking them to rush approve the 21st Century Cures Act. Anyone who does not do this is not helping to overcome baldness. Anyone who does not do this is a slacker who does what he can to contribute to the cause of defeating baldness.