Neosil phase two study RESULTS.....

[michael barry]

I hate to be a bearer of bad news, but that hair count increase and thickness increase isn't as good as minoxidil's...............this isn't going to be revolutionary or anything like that. I dont know if its even worth pursuing further. Five percent increases in hair counts at 24 weeks just isn't much if a guy is very thin on top. 3.7 percent increases in thickness..............just aint much. Like Ive said, we need something that will put NEW hair up there




FOR IMMEDIATE RELEASE Click Here for Our Nov. 8th 2004 Press Release





NEOSIL ANNOUNCES POSITIVE PHASE 2 DATA FOR NEOSH101, AN INVESTIGATIONAL TREATMENT FOR ANDROGENETIC ALOPECIA

Emeryville, CA – January 4, 2007 – Neosil, Inc., a privately held dermatology-focused pharmaceutical company, today announced positive Phase 2a clinical data demonstrating that its lead product, NEOSH101, increased hair growth significantly in men diagnosed with androgenetic alopecia, also known as pattern hair loss (PHL). Androgenetic alopecia or PHL, caused by a combination of genetic and hormonal factors, is noticeable in about 20 percent of the population by age 20 and increases steadily with age. By age 50 approximately half of the U.S. population will have some degree of PHL. “

Based on the results of this study, we are quite encouraged by the increase in hair growth observed after such a short once-daily treatment regimen with NEOSH101,â€￾ said Vera H. Price, MD, FRCP(C), Professor of Clinical Dermatology, Department of Dermatology, University of California, San Francisco.

In a randomized, double-blind Phase 2a clinical study, conducted in Germany, 50 men with androgenetic alopecia (Norwood/Hamilton grades III-IV) received once-daily topical treatments of NEOSH101 or placebo over two 14-day treatment periods, which were separated by a one-month drug-free interval. Hair growth was measured using an objective photographic, computer-based analysis for up to 24 weeks after initiation of therapy. Results show that NEOSH101 was safe and well tolerated. A statistically significant increase in total hair count (4.8%, p=0.04), and cumulative hair thickness (3.7%, p=0.02) were observed, with peak effects occurring eight weeks following the second treatment cycle.

“The results of this study are encouraging, particularly the finding of increased numbers of terminal hairs, those hairs that are thicker than 40 microns and desirable for scalp coverage,â€￾ said Andria Langenberg, M.D., Vice President of Clinical Development at Neosil. “We plan to initiate a Phase 2b study to evaluate daily treatment with NEOSH101 for a longer treatment period in men with PHL.â€￾


About Neosil



Neosil, Inc. is a privately held dermatology-focused pharmaceutical company that was funded in November 2004 with a $32 million investment by MPM Capital and Burrill & Company, following initial incubation funding by Shalon Ventures, LP. In addition to its topical hair growth product, NEOSH101, Neosil is developing a broad-spectrum topical anti-microbial agent for acne and anti-infective use.


CONTACT:

Neosil, Inc.
ATTN: Eugene Bauer, M.D.
5980 Horton St., Suite 525
Emeryville, CA 94608
510-547-3610
510-547-3604 fax
info@neosil.com

Click Here for Our Nov. 8th 2004

 

[SoThatsLife]

January 4, 2007?

Havnt they just started Ph2c, not much point to release/researching a product that have less impressive result that the already existing one? Its to bad that nutting seems to grow one vellus hair into one good thick hair. I was really hoping that Neo was a better version of minoxidil, but yes, hair loss research is all about failure.

 

[sphlanx2006]

michael isnt this the data released on the "small" trial were patients were treated only once a day for only two 14-days period? I thought i have read this a long time ago, and it was positive because the dosage and the time of application were very small, yet it had some good results. I am confused over this :|

 

[michael barry]

Splanx.........hmmm....Im going to paste and try to decipher what they were doing...

in Germany, 50 men with androgenetic alopecia (Norwood/Hamilton grades III-IV) received once-daily topical treatments of NEOSH101 or placebo over two 14-day treatment periods, which were separated by a one-month drug-free interval. Hair growth was measured using an objective photographic, computer-based analysis for up to 24 weeks after initiation of therapy. Results show that NEOSH101 was safe and well tolerated. A statistically significant increase in total hair count (4.8%, p=0.04), and cumulative hair thickness (3.7%, p=0.02) were observed, with peak effects occurring eight weeks following the second treatment cycle.

O.K. Sphlanx................it looks like the treated men for:

14 days of Neosil (2 weeks)
One month of nothing
14 days of Neosil again (2 weeks)
Two months
Peak effect measurement two months (8 weeks) after stoppage of Neosil....................this is four months in.
Two more months,
End of trial (24 weeks).


So that is two months worth of treatment. Hair growth was measured for up to 24 weeks after the beginning of topical application, which would be four months after they stopped getting Neosil. Peak effects were observed eight weeks (2 months) after the second treatment cycle-----and four months into the trial.



The "bad news" is that "putting more of it on you" probably wont help that much if at all. We will see................but they need to put it on up there for a full year to get an idea if its going to be MORE helpful than a mere 4.8% increase in hair count in thinning areas.



I dont know if this can be as good as, or better than minoxidil.....................but I'll tell you this............fluridil increased the anagen percentage of hairs from 77% to 86% at six months in guys with Androgenetic Alopecia. That would be more than a ten percent increase in density almost assuredly if all the hairs had the same size as before....................and its likely that the size of the hairs would have increased.

I think a topical anti-androgen applied to the entire male pattern bald area is the place to START treatment. In my honest opinion, unless they find "it"-or the reason that hairs miniaturize downstream of androgens, prox-n will remain the best regrowth agent and stimulant out there for some time. If they find "it", then we may have something better..........but I doubt we will have it before then.

 

[bornthisway]

Neosil's product if I remember correctly works via BMP signaling. I believe some years ago a product came out that claimed to work via BMP signaling which was ineffective... though I'm more hopeful for Neosil or newer treatments as our understanding of the pathway unfolds (which is likely years off.. just go to pubmed and look for BMP, a good majority of the research on hair is recent -- and only a few articles, you'll find many other processes, factors and pathways mentioned.).

Released: Wed 13-Feb-2008, 15:55 ET

Protein Maintains Cross Talk Between Cells That Control Hair Growth

Description
Scientists have identified a signaling molecule that is critical for a type of skin cell, called dermal papilla, to ratchet up or clamp down the activity of genes that give them their molecular identity. Without these signals, these skin cells lose their hair-inducing properties -- findings that may provide a new understanding of how stem cells differentiate.

Genes, it turns out, are only as active as the signals that turn them on and off. Now scientists from Rockefeller University and the Howard Hughes Institute have identified the signaling molecule that ratchets up and clamps down the activity of key genes in dermal papilla, a type of skin cell whose unique collection of proteins ultimately instruct epithelial stem cells to make hair.

The research, which will be published in the February 15 issue of Genes & Development, highlights the cross talk between these two cell types and how this signaling molecule, a protein called BMP, is crucial for this exchange.

Epithelial stem cells nest in the upper portion of the adult hair follicle, and dermal papilla reside nearby in the mesenchymal layer below them. It is thought that the communication signals between the two cell types instruct the stem cells to form hair follicles during embryogenesis, and then, when these follicles have matured, regulate their cycles of hair growth and regeneration. "Scientists don't know how dermal papilla cells are programmed to provide the instructive signals to stem cells, but now we know that BMP signals play a crucial role," says Michael Rendl, who conducted this work while he was a postdoc in Elaine Fuchs's Laboratory of Mammalian Cell Biology and Development.

For several years, it has been known that BMP signaling must be reduced in order to activate follicle stem cells. "Michael has now uncovered a new twist to the story," says Fuchs, who is Rebecca C. Lancefield Professor at Rockefeller and an investigator at the Howard Hughes Medical Institute, "namely that dermal papilla cells appear to receive BMP signals from their surrounding microenvironment and this signaling is required for these two cell types to maintain cross talk."

Fuchs conducted the study with Rendl, who found that BMP6, a member of the BMP family of proteins, orchestrates dermal papilla's signature genes to turn on and off, thereby giving these skin cells their unique collection of proteins and features.

Fuchs's team developed a clever strategy to delete several genes in vitro, ones that encode for the receptor onto which several BMPs bind. They then grafted these genetically engineered dermal papilla cells onto the backs of bald mice to see if these mice would grow hair.

Well, the mice didn't. When dermal papilla cells lacked this receptor, their signature proteins were not expressed and the key signaling that occurs between epithelial stem cells and dermal papilla was impaired. Without this exchange, the hair follicles did not grow or make hair.

Nearly all of the signature proteins that Rendl and Fuchs tested in dermal papilla cells decreased when they deleted the BMP receptor. The exception: BMP6 itself. This increase in BMP6 expression levels suggests that BMP6 is necessary for both locking in dermal papilla's molecular identity as well as maintaining the crosstalk that allows stem cells to receive hair-inducing signals, but it itself is not the signal that stem cells await. This finding also provides clues to the type of signals that follicle stem cells may send to dermal papilla.

What's more, BMP6 specifically maintains the molecular identity of dermal papilla cells. When Rendl and Fuchs induced the BMP pathway in other cell types that respond to BMP signaling, they found that these cells continue to produce the normal amount of their signature proteins. "This was really interesting," says Rendl. "It is likely the case that different signaling pathways, or a combination of them, regulate different sets of genes to give each cell type in the hair follicle its characteristic properties."

Fuchs speculates that "this complex circuitry in BMP signaling may set the foundations for a BMP regulatory clock that drives the hair cycle. If so, we may be one step closer to unlocking nature's secrets to hair growth."

This research was supported in part by the Tri-Institutional Stem Cell Initiative, a collaborative program of three New York City biomedical research institutions -- Memorial Sloan-Kettering Cancer Center, The Rockefeller University and Weill Cornell Medical College.

Hair follicles cannot grow properly (bottom) when a type of skin cell called dermal papilla lacks the receptor that binds BMP, a signaling molecule that, when present, instructs stem cells to trigger hair follicles into action and make hair (top).

 

[harold]

The "bad news" is that "putting more of it on you" probably wont help that much if at all. We will see................but they need to put it on up there for a full year to get an idea if its going to be MORE helpful than a mere 4.8% increase in hair count in thinning areas.

Exactly. There is a reason for the seeming underuse of this product and I'm sure its because the data they had to hand indicated that that would probably be the best place to start instead of just lathering it on everyday. What we know when you mess with BMP/wnt growth inhibitory/proliferative signals is that timing is everything. Too much of a "good thing" will certainly be a bad thing just as too much of a "bad thing" is. Normal hair cycles and falls out after all.
In fact Neosil as far as I can gather is a "bad thing" BMP is generally a hair growth inhibitor. However BMP signalling is necessary for hair growth and the coexpression of BMP and wnt signalling seems necessary for the prolonged anagen period of the hair cycle while BMP alone signals the end of the hair cycle and wnt alone induces anagen very generally speaking. but too much or too little of either means less hair.

I could be wrong on this but I dont think they would go from this to a daily routine and if they did I dont think the results would reflect the increased application of the product.

I dont know if this can be as good as, or better than minoxidil.....................but I'll tell you this............fluridil increased the anagen percentage of hairs from 77% to 86% at six months in guys with Androgenetic Alopecia. That would be more than a ten percent increase in density almost assuredly if all the hairs had the same size as before....................and its likely that the size of the hairs would have increased.

I'm not sure about how a change in percentage of anagen hair follicles would immediately translate into in terms of density. In the long term its absolutely the best news for an male pattern baldness sufferer since as the disease progresses more and more hairs are spending most of their time in telogen. But all my hairs could go into anagen tomorrow and I might still sit here with the same head of hair. For a while at least. Similarly if a whole bunch of follicles went into anagen the first sign might be a massive shed with a corresponding loss of density. I find it hard to compare therefore. But you may be right. I am just being cautious.
hh

 

[JayB]

I'm not sure about how a change in percentage of anagen hair follicles would immediately translate into in terms of density. In the long term its absolutely the best news for an male pattern baldness sufferer since as the disease progresses more and more hairs are spending most of their time in telogen. But all my hairs could go into anagen tomorrow and I might still sit here with the same head of hair. For a while at least. Similarly if a whole bunch of follicles went into anagen the first sign might be a massive shed with a corresponding loss of density. I find it hard to compare therefore. But you may be right. I am just being cautious.
hh

EXACTLY. just because theres a huge increase in anagen hairs does not translate into a better head of hair. Regrowth is the key for balding scalps. You could keep every hair on a NW4 in the anagen phase and brag about the 100 percen increase in anagen hairs, but at the end of the day is he not still a NW4?

A 4% increase in hair means just that, on a NW4, 4% of the hairs on his head are now new. What that number actually means in terms of rivaling minoxidils numbers, I am not sure. I am unsure how much percentage regrowth minoxidil can claim.


ALso- Michael Barry, why is Prox-N the best agent for regrowth? Is there anything in it thats works as an antiandrogen for those of us not on propecia

 

[bobs]

This is last years news...? (ph2a results)

The rest of the 2b&2c results should be up soon.

 

[SoThatsLife]

This is last years news...? (ph2a results)

The rest of the 2b&2c results should be up soon.

Ph2b is done and is hopefully coming soon, ph2c is starting soon I think

 

[sphlanx2006]

EXACTLY. just because theres a huge increase in anagen hairs does not translate into a better head of hair. Regrowth is the key for balding scalps. You could keep every hair on a NW4 in the anagen phase and brag about the 100 percen increase in anagen hairs, but at the end of the day is he not still a NW4?

I think you miss the point there. If a norwood4 has 50,000 hair a 70% of them are on anagen that means that aprroximately 35000 hair are COVERING his head AT THE MOMENT. If you raise this percentage to 86% that means that right now he has 43000 hairs COVERING HIS HEAD. Thats 8,000 more hair. In my opinion raising the percentage of hairs in anagen is translated into direct increase in hair density.