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May not even need a HT for that matter, probably being too hopeful but from what I've read on it the pathway is able to promote hair growth in dormant follicles therefore awakening them and thickening. We'll have to wait and see the results, but it does sound promising.
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I think that the fact that the company is doing this 2nd study is a VERY positive development.
a) The company likely knows by now whether or not the test subjects in the phase 2 study grow hair or not.
b) The company likely would have done the biopsies in the original phase 2 study if they intended to do biopsies all along so it's likely that the idea of doing this biopsy study is something they only recently decided to do.
c) It's very doubtful that they would have decided to do this special phase 2 study if they did not see positive results from the original phase 2 study.
So they likely know if their drug grows hair or not and they decided to invest more money into another trial
ALSO
d) I've been reading on the internet where experts are saying that the new FDA law will allow companies to move their treatments into the marketplace after phase 2 studies if the treatment is "groundbreaking" and the FDA is agreeable.
e) By Samumed doing this additional study they are securing more information that they can turn over to the FDA.
f) Samumed is surely aware of the new FDA law that might become law.
It looks to me like there is a possibility that Samumed may have decided that by doing the additional phase 2 study (involving biopsies) they could get more info to turn over to the FDA and then maybe the FDA would let their drug into the marketplace after phase 2. And the timing fits this scenario because the new phase 2 will be done by the end of January and of course the new FDA law will become law (or rejected) just about that same time. The timing makes it look to me like Samumed may have had the new law in mind when they decided to do this additional phase 2.
Also, they may have figured out that if they instead set-up for a phase 3 study then that phase 3 study will cost them a lot more money and a phase 3 study will make it take longer to get their drug to market so they'll have to wait longer to start earning profits from the drug, and it's a bad thing to take longer to get to market because other breakthrough treatment(s), such as Shisheido's advertised iPS cells, will come to market soon and grab a big chunk of market-share.Comment
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Prague Jan 2014
Signaling Involved in Hair Follicle Morphogenesis
and Development
HF morphogenesis starts at an early embryonic stage. Its proper development and
regular cycles involves a strong interplay between Wnt, Hedgehog, Notch and bone morphogenetic
protein (BMP) signaling pathways.
"The Wnt pathway is considered to be the master regulator during
hair follicle morphogenesis
Currently,
only a few attempts to modify these pathways have been performed in the treatment of abnormalities
such as alopecia. Although some promising drugs have emerged with the ability to target pathway
effectors, providing some success in the treatment of hair follicle abnormalities"Comment
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They should try to make wnt inhibitor for hair removal :d
But of course first hair regrowth !!!
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So any one in US is interested to participate SM phase 2 complement? still 90 days of topical application
There's still 3 locations that recruiting
Research Site Recruiting
College Station, Texas, United States
Contact: Jeremy Scott jscott@js-studies.com
Principal Investigator: Terry Jones, M.D.
Research Site Recruiting
Houston, Texas, United States
Contact: Amanda Herod aherod@sba-skincare.com
Principal Investigator: Suzanne Bruce, M.D.
United States, Virginia
Research Site Recruiting
Lynchburg, Virginia, United States
Contact: Sue Foster sfoster@educationandresearch.com
Principal Investigator: Janet Hickman, M.D.
The new outcome measures are really interesting, with the scalp biopsy analyze
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Hey dude I read more the exclusion criterias and sorry but :
Use of any products or devices clinically proven to promote scalp hair growth (e.g., finasteride or minoxidil) within 24 weeks prior to study start
So 24 weeks it's when they will finish this little trial
But you are Lucky if you have some regrowth ^^ what is your regimen?Comment
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I would actually be interested as I'm also in Dallas and I frequently visit College Station. I'm not on Fin, Min, etc, so I'm good on that aspect.
However, I don't think I meet Norwood criteria. Also, I'm not sure if I feel experimenting with possible cancer-causing pathways.
Although, after reading this thread, I am quite interested in this product and will be anxiously waiting for the results.
A quick question:
Are we aware of any connection between the Wnt pathways and COX/PGD/PGE pathways, which also seems to be a strong theory based on a lot of scientific research?Comment
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So how do they know if anyone is actually on fin, minox or any other hair product. Do they test for traces of these drugs in your system?
Basically im asking, if we lie and say we are not using other treatments how do they know if thats true or not?Comment
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GUYS I really think this drug will be huge when I read this !! (this come from Fujiwara Lab, (lab from RIKEN center where there is Tsuji lab aswell)
The Wnt/β-catenin signaling pathway has been found to play a crucial role for hair follicle development and regeneration, and stimulation of stem cell growth, maintenance and differentiation.
Our another recent study has revealed that activation of canonical Wnt/beta-catenin signalling in the epidermal stem cell population, induces differentiation of dermal adipocyte progenitors
We showed that periodical activation of epidermal Wnt/beta-catenin signalling during hair growth cycle induces morphogenesis and regeneration of the hypodermis by triggering the secretion of epidermal adipogenic factors, synchronizing the hair follicle growth with underlying dermal adipocyte differentiation.
Thus, our recent findings indicate that hair follicle epidermal stem cells not only contribute to hair follicle maintenance and regeneration, but also provide niches for dermal cell populations"
Now when we look more precisely their study
:
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).
When the Wnt pathway is activated at high levels in adult mouse epidermis, ectopic follicles form from existing follicles, interfollicular epidermis (IFE) and sebaceous glands, revealing a remarkable ability of the tissue to be reprogrammed
So it seems like SM could , not only help existing and dormant follicles, but also create NEW FOLLICLES from existing ones!!!Comment
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Agreed - getting proper modulation of the Wnt pathway could change everything. As Cotsarelis has highlighted, the stem cells are still there - they just need to be turned back on. Let's hope this drug can pull this off...Comment
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Cotsarelis 2007
When a wound is formed on the skin, stem cells can decide to become skin cells or hair follicle cells.
In the majority of the cases, they become skin cells so as to quickly heal the wound. In mice, the team found that if Wnt is restricted, no hair follicles are formed, so the mice become bald; if more Wnt is present, hair growth is increased.
Cotsarelis, Millar 2013
if delivered in a limited, safe and controlled way, agents that activate Wnt signaling might be used to promote hair growth in dormant hair follicles in conditions such as male pattern baldness,” said senior author Sarah Millar, PhD,
Researchers aim to better understand the key components and functions of the Wnt/β-catenin pathway. Important areas of focus for future work will include developing effective means of safely targeting therapeutics to the skin for clinical and cosmetic applications.
safely targeting therapeutic is what SM is ( for the moment)
Now what's happen if you put SM on the scalp just after the cotsarelis wounding clinical procedure??
After a wound, SM could be the key to decide stem cells to become HF cells instead of skin cells.
Now that I now that activation of Wnt/B catenin pathway could create NEW follicles from existing ones, it really makes me want to believe that SM could be the 'safely targeting therapeutic for skin' that follica need to apply after wounding. I'm maybe too optimistic but that b-catenin pathway world looks so good
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Any idea on what's going on with cotsraelis & follicabio?Comment
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