They Already Made A Side-free Topical Antiandrogen, And It Wasn't Trialed For Baldness

[whatevr]

From what I've searched nobody knows about this and it slipped right past everyone in the hair loss community.

https://pdfs.semanticscholar.org/0abb/b2070ba52d932bf6bcc83f10d0e6f7975a63.pdf

Novan Therapeutics, a clinical-stage drug-development company, has developed drug candidate SB204, which releases nitric oxide when applied topically to the skin. Based on results from animal studies, locally available nitric oxide may inhibit skin steroidogenesis resulting in reduced levels of androgens like testosterone and 5α-dihydrotestosterone(5α-DHT). Androgens in skin are thought to stimulate oil production that drives the development of acne as well aspromote hair loss in men. By reducing androgen levels locally in skin, topical nitric oxide maylead to first-in-class local antiandrogen therapiesused to treat these disease processes.

SB204 significantly inhibited the growth of androgen-dependent hamster flank glands.Inhibition occurred faster at higher doses and was first evident at 14 days at the highest dose. After 28 days of dosing, all doses significantly inhibited flank gland growth compared to the gelvehicle control group (Figure 3).

Nonclinical studies performed to date have not shown any safety concerns or appreciable systemic exposure when applied topically to rodents and minipigs for as long as 28-days in repeat-dose studies. These results indicate that nitric oxide therapies applied topically may induce only local –and not systemic –effects on steroidogenesis and lipidbiosynthesis, suggesting SB204 has the potential to be a first-in-class local antiandrogen.

http://novan.com/pipeline/

It reached Phase 3 for acne just like Winlevi, but so far is only a "potential" application in Alopecia.

 

[MeDK]

No big news in growing new hairs on animals.

Just rub a wooden board on a mouse and you can grow hair on it.

What we want to see is human trails, that is all that counts. Animal models doesn't translate 1:1 to humans and never have.

 

[whatevr]

I have doubts though.

What makes this different to all the other topical AA's that claimed to be safe and have no systemic effects yet many still experienced side effects?

Are the mechanisms of this so different then?

If you read the PDF in the OP:

While nitric oxide released from SB204 is anticipated to be pharmacologically active in the skin, it is expected to be extremely short-lived (milliseconds) and local. Nitrate is quantitatively the most important end product of nitric oxide metabolism after subcutaneous nitric oxide administration (Benthin 1997); hence nitrate levels were measured in nonclinical studies to assess the potential for systemic bioavailability. Maximum feasible doses were assessed(maximum feasible concentration and maximum feasible volume applied over 10% of the total body surface area). Nonclinical studies performed to date have not shown any safety concernsor appreciable systemic exposure when applied topicallyto rodents and minipigs for as long as 28-days in repeat-dose studies.

 

[whatevr]

No big news in growing new hairs on animals.

Just rub a wooden board on a mouse and you can grow hair on it.

What we want to see is human trails, that is all that counts. Animal models doesn't translate 1:1 to humans and never have.

They HAVE done trials on humans for acne, and it's as effective as Winlevi (CB 1%) in that case.

The point here is that they have not bothered to do trials for Androgenic Alopecia, even though this could be probably a good side-free treatment for many people, because they don't give a f***, and it's not profitable for them unless it grows tons of hair. Treatments like this should be on the market for people <NW2 who just want to keep their damn hair without side effects, but because companies are only looking for huge return on investment nobody bothers marketing sh*t that doesn't go from NW7->NW1. The 'maintenance abyss'.

 

[MeDK]

They HAVE done trials on humans for acne, and it's as effective as Winlevi (CB 1%) in that case.

The point here is that they have not bothered to do trials for Androgenic Alopecia, even though this could be probably a good side-free treatment for many people, because they don't give a f***, and it's not profitable for them unless it grows tons of hair. Treatments like this should be on the market for people <NW2 who just want to keep their damn hair without side effects, but because companies are only looking for huge return on investment nobody bothers marketing sh*t that doesn't go from NW7->NW1. The 'maintenance abyss'.

because you can run a company without profits, because we live in a world without inflation and free R&D.

 

[whatevr]

because you can run a company without profits, because we live in a world without inflation and free R&D.

I very much doubt it wouldn't be profitable. They would at the very least break even, but perhaps not enough for the CEO to buy another yacht, which is reason enough to be considered 'not profitable'.

 

[MeDK]

I very much doubt it wouldn't be profitable. They would at the very least break even, but perhaps not enough for the CEO to buy another yacht, which is reason enough to be considered 'not profitable'.

if something is break even, then it doesn't make profit, then it only paid for its self. But what people sometimes fail to understand, if you have $100 dollars today, that value will be lower next year, and the reason is inflation. Remember that when you want a raise. That means your salary should increase a certain %+ the inflation% or else you lost money and didn't get a raise.

That is why you need a quite good ROI to be able to run a business. Or else you lose money quite fast.

 

[whatevr]

if something is break even, then it doesn't make profit, then it only paid for its self. But what people sometimes fail to understand, if you have $100 dollars today, that value will be lower next year, and the reason is inflation. Remember that when you want a raise. That means your salary should increase a certain %+ the inflation% or else you lost money and didn't get a raise.

That is why you need a quite good ROI to be able to run a business. Or else you lose money quite fast.

We are talking here about a drug that people would start to take at an early age to prevent hair loss. The average 20 years old starting to use this would be on the drug for as long as they wanted to keep their hair, say 20-30 years. With a drug like that, it's not a question IF it will pay for itself, but a question of when. A patent on a medical invention is 20 years. I am fairly certain that the amount of people using the drug would be enough to make a fair profit during that time frame.

 

[Armando Jose]

A 2004 paper of Tempol (nitroxides) to treat hair loss induced by radiation
http://clincancerres.aacrjournals.org/content/10/19/6411.long

I remember Bryan Shelton talking about it

 

[DoctorHouse]

A 2004 paper of Tempol (nitroxides) to treat hair loss induced by radiation
http://clincancerres.aacrjournals.org/content/10/19/6411.long

I remember Bryan Shelton talking about it

Yes, Bryan did because it was in Dr Proctor's products such as Proxiphen, Prox-N, and Nano shampoo. I remember Proctor posting about it on here.

 

[opti]

http://novan.com/files/1315/1610/8017/SB204_Adolescent_Winter_Clinical_Poster_vf.pdf here you can see the results tested on HUMANS.

Looks for me like this stuff is not strong enough for male pattern baldness. It helps a bit with acne (not 100% though), but could be too weak for MBP. But maybe someone can test it when it gets out.

 

[whatevr]

http://novan.com/files/1315/1610/8017/SB204_Adolescent_Winter_Clinical_Poster_vf.pdf here you can see the results tested on HUMANS.

Looks for me like this stuff is not strong enough for male pattern baldness. It helps a bit with acne (not 100% though), but could be too weak for MBP. But maybe someone can test it when it gets out.

CB at 1% (Winlevi) doesn't fare much better against acne either yet it is marketed. It's used at 7.5% twice a day for Androgenetic Alopecia though - who's to say you couldn't just bump up the concentration on this drug as well for hair loss?

 

[jamesbooker1975]

A 2004 paper of Tempol (nitroxides) to treat hair loss induced by radiation
http://clincancerres.aacrjournals.org/content/10/19/6411.long

I remember Bryan Shelton talking about it

I miss Bryan, and I miss that days. passed 22 years on hairloss forum, but we still have the same treatments.

 

[jamesbooker1975]

Sorry to tell you that this Clinical trial is dead. Started on June 2016, should be already submit it for the FDA, and they don't even have a commercial name for the drug.

 

[TK421]

If this ever gets approved for acne I'm sure you could find a doctor that would prescribe it for off label use. The question is when will it get approved for treatment of acne?

 

[Capone]

I miss Bryan, and I miss that days. passed 22 years on hairloss forum, but we still have the same treatments.

What did he die from?

 

[Badbald]

It dosent say when phase 3 is projected to end. Does anyone know anymore on this?

 

[Long John Silver]

Didn't this fail bro and so they gave up on the pipeline with no updates to the clinical trial?

 

[jamesbooker1975]

It dosent say when phase 3 is projected to end. Does anyone know anymore on this?

Yes, it was complete on 2017 , you can see it on clinicaltrials.gov

 

[BalderBaldyBald]

What did he die from?

From life, does it matter ?