RU58841 Made it into Phase II clinical studies, Results Here

[Bryan]

As many of you know RU58841 was developed in France by Dr. Sewaya of the Roussel Uclaf Corporation.

Where on earth did you get the idea that Dr. Sewaya had anything to do with the development of RU58841?? It was developed by T. Battmann and his colleagues.

 

[Bryan]

Where on earth did you get the idea that T. Battmann (AKA Bruce Wayne) and his colleagues (AKA Robin & Batgirl) did?

???

From the original 1994 study on RU58841. Here are the authors of that study: T. Battmann, A. Bonfils, C. Branche, J. Humbert, F. Goubet, G. Teutsch, and D. Philibert.

 

[Bryan]

I read that, I will post the link below. My source had six references at the bottom of the page. Either way ProStrakan owns it now, that is a fact!

My source- http://tressless.com/learn/RU58841

I don't think your source had any idea what he was talking about, because Battmann and his colleagues are clearly the guys who developed RU58841.

I _do_ have a copy of a study by Sewaya, in which she did some testing of RU58841, and seemed to be impressed by it (in it, she referred to the original Battmann study from 1994). Maybe your "source" saw that same study, and jumped to the really weird conclusion that it was Sawaya who designed the drug in the first place!! :shock: :dunno:

 

[Bryan]

By the way, the correct spelling of her name is in fact Sawaya, not Sewaya. Her nickname (she uses it herself) is "Marty". Marty Sawaya.

 

[Ende]

Where on earth did you get the idea that T. Battmann (AKA Bruce Wayne) and his colleagues (AKA Robin & Batgirl) did?

???

From the original 1994 study on RU58841. Here are the authors of that study: T. Battmann, A. Bonfils, C. Branche, J. Humbert, F. Goubet, G. Teutsch, and D. Philibert.

Where's your sense of humor, Bryan?

 

[Ende]

The hypotheses underlying this study were:
1. Once-daily treatment with PSK 3841 solution at 5% was to result in a significant increase in hair growth, when compared to daily treatment with vehicle
2. There should be a difference between the two active treatments (2.5% and 5% once-a-day)
3. Treatments should be safe and well tolerated in men with male pattern baldness

Since they applied the solution twice a day in P1 and anticipated once a day application to significantly increase hair growth in P2, they obviously discovered that once a day application was enough. It's annyoing that they don't mention anything about the amount of solution for each application... Bryan do you know? I think it's safe to say that they didn't use less than 0.5 ml a day, like they did in the animal studies. It seems like they compared it to Rogaine, and I doubt they used more than 1 ml for each application. The drugs are usually only tested on the crown, and 1 ml is sufficient to cover the area. That means that the amount of drug was probably 12.5mg and 25mg a day, or 25 and 50 mg a day. Good news is that they concluded that the drug was safe during P1, regarding systemic absorption, and I therefore believe that the drug content was 12.5 mg for the 2.5% solution, and 25 mg for the 5% solution since I experienced side effects with 50 mg once a day. I think they abandoned the drug because the results appeared similar to Rogaine.

 

[Bryan]

Where on earth did you get the idea that T. Battmann (AKA Bruce Wayne) and his colleagues (AKA Robin & Batgirl) did?

???

From the original 1994 study on RU58841. Here are the authors of that study: T. Battmann, A. Bonfils, C. Branche, J. Humbert, F. Goubet, G. Teutsch, and D. Philibert.

Where's your sense of humor, Bryan?

I just now got the joke!!! :shock:

 

[robert west]

Phase I clinical trials for PSK3841 (AKA RU58841)- http://www.controlled-trials.com/ISRCTN49873657/

Phase II clinical trials for PSK3841 (AKA RU58841)- http://www.controlled-trials.com/ISRCTN71083772/

While this is good to know, where are the actual results? Is this stuff promising?

 

[CCS]

That link provides even less information than the first two.

Has anyone seen the results of the phase II trials?

 

[nero]

I would like to know if anyone has the answers to what enden just asked?

 

[CCS]

A lot of companies come up with stuff better than what we have now, but they won't pay for phase III trials unless it is a LOT better than what we have now. Tricomin never had phase III trials, but it is on the market after Phase II. Why don't the others do that too?

 

[el_duterino]

it takes a lot of money and time to do all the tests, for a drug which is similar to finasteride or a bit better in terms of results.

Then there is a risk of lawsuits from young, healthy guys if there are issues.

finasteride had all the tests done for the prostate reducing drug already..no need to start from scratch.

 

[Ende]

To assess the systemic and local safety and tolerance of 5% PSK 3841 solution versus vehicle (70% ethanol) when administered topically twice-a-day over 4 weeks on the scalp of Caucasian males with androgenic alopecia.

It seems like they used only ethanol (70%) as vehicle in the PSK study? It's pissing me off that they don't reveal the amount of drug which they used. However, like I said; the drugs are usually only tested on the crown, and 1 ml is enough to cover the crown properly. The 2.5% and 5% solutions seems likely to be 25mg and 50mg. What do you think? For those of you who don't know, my scale was broken, so I could've used more than 50 mg for the first applications.

 

[Todd]

A lot of companies come up with stuff better than what we have now, but they won't pay for phase III trials unless it is a LOT better than what we have now. Tricomin never had phase III trials, but it is on the market after Phase II. Why don't the others do that too?

I've been wondering about that to.
Roxithromycin also stopped in phase II, as did NEOSH- something, and a few other promising candidates..

I'm thinking that since finasteride is the gold standard, any new treatment has to get results equal to- or ideally better than- finasteride in order to have any real marketing value. (There's really no marked in targeting people who are experiencing or are afraid of side effects). If you lose hair, and a doctor gives you a choice between a pill that has a 90% chance of maintaining, or a topical solution (which maybe makes your hair feel greasy or sticky and/or smells) with a 60% chance of maintaining, the choice is pretty easy.

Alternatively, you can come up with a compound that can be sold OTC (like minoxidil), but then you have to make sure that this qualifies for OTC (I don't know the criteria, but I'm guessing no systemic side effects sould be one of them) AND that it can compete with minoxidil (maybe this is what happened to roxithromycin and tricomin. Safe, non systemic, with results, but not as effective as minoxidil...)

I'm guessing RU had great results, but since it's not in a pill, it's considered inferior to finasteride, and since it's such a powerful compound, there's no way it's going to be OTC...

In other words: RU does not make money

 

[CCS]

Are all three suppliers the same price/quality/ease of getting to the US?

 

[captain_que]

I'm thinking that since finasteride is the gold standard, any new treatment has to get results equal to- or ideally better than- finasteride in order to have any real marketing value. (There's really no marked in targeting people who are experiencing or are afraid of side effects). If you lose hair, and a doctor gives you a choice between a pill that has a 90% chance of maintaining, or a topical solution (which maybe makes your hair feel greasy or sticky and/or smells) with a 60% chance of maintaining, the choice is pretty easy.

It´s becoming more widely known that finasteride produces bad side effects in far more than the 2% stated on the package. What would you choose; a 90% chance of keeping your hair and zero chance of performing on any woman you took home due to your huge mane, or a 60% chance of keeping your hair and a 99% chance of doing what´s expected of you when pulling a female´s panties off...?

Seriously, finasteride is artificially the major hairloss product. In the unlikely event that everyone would stop buying finasteride, new treatments would pop up all over the place; very possibly with the same owners.

 

[Ende]

I'm guessing RU had great results, but since it's not in a pill, it's considered inferior to finasteride, and since it's such a powerful compound, there's no way it's going to be OTC...

Inferior? It's definately easier to swallow a pill every day, but local treatment is usually superior to systemic treatment in relation to side effects. A potent, topical anti-androgen takes care of the problem. It binds to the androgen receptors on your scalp, and thereby block all androgens, not just DHT. Reductase inhibitors only reduce the amount of DHT. Already there RI's are inferior to a potent, topical anti-androgen like RU58841. Reductase inhibitors slows down the miniaturization process, and sometimes at the horrible cost of sexual problems, gynecomastia and even hypogonadism. Topical anti-androgens like RU58841 halt the balding process, without systemic side effects at the correct dose.

It's a lot of money in an effective, topical anti-androgen with no systemic side effects. Many people are waiting for CB-03-01.

 

[Todd]

I'm guessing RU had great results, but since it's not in a pill, it's considered inferior to finasteride, and since it's such a powerful compound, there's no way it's going to be OTC...

Inferior? It's definately easier to swallow a pill every day, but local treatment is usually superior to systemic treatment in relation to side effects. A potent, topical anti-androgen takes care of the problem. It binds to the androgen receptors on your scalp, and thereby block all androgens, not just DHT. Reductase inhibitors only reduce the amount of DHT. Already there RI's are inferior to a potent, topical anti-androgen like RU58841. Reductase inhibitors slows down the miniaturization process, and sometimes at the horrible cost of sexual problems, gynecomastia and even hypogonadism. Topical anti-androgens like RU58841 halt the balding process, without systemic side effects at the correct dose..

You know this, and I know this, and people who bother to educate themselves would problably rather have a topical anti- androgen than a systemic androgen inhibitor. I would love to switch to CB-03-01, if/when it reaches the pharmacies.

My point is: by being a pill, and by having such great results and (for many lucky people) having no noticable side effects, finasteride has a gigantic marketing advantage, because most people don't bother to educate themselves. And since ANY baldness treatment claims to maintain and regrow, and since EVERY SINGLE PHARMACEUTIC compound, downplay their side effects (regardless of "the truth") the uneducated choice between a pill and a topical solution becomes pretty easy.

 

[el_duterino]

RU58841 (or CB) has far more potential than finasteride because you can use a lot more and still have no side effects.

The effect of RU is dose dependant.

In addition, RU (CB) also blocks other androgens such as Testosterone, which are know to bind to the AR and trigger hairloss as well.

CB won't "hit the pharmacies" for another 5 years at least so I plan to continue using RU during that time...both drugs have the same mode of action.

 

[Todd]

5 years, eh?

Fingers crossed. But I really think the test results would have to match/superceed those of propecia (and/or proving substantially less side effects) for it to have any real competing chance (No, not in terms of growing hair- in terms of marketing)

With Glaxosmsmith pushing Dutasterid into the marked (is it phase III already??) Any topical solution (unless it's OTC and/or REALLY cheap) would need REMARKABLE results to take a stand in a marked where finasteride 1mg soon loses its patent (prices will drop), and dutasteride soon hits the shelves.