bimatoprost

bimatoprost whats stopping people from getting that over drug Latisse.

BUMP

Whatever happened to bimatoprost as a possible new growth stimulator? Is it another premature failure?

Not worth it for how much money it costs to use and maintain. Apparently works alright, though. So not a complete failure..

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Originally Posted by clandestine

Not worth it for how much money it costs to use and maintain. Apparently works alright, though. So not a complete failure..

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Really, it got released properly as a hair loss treatment? You don't mean just people using the womens eyelash stuff off-label?

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Originally Posted by Pentarou

Really, it got released properly as a hair loss treatment? You don't mean just people using the womens eyelash stuff off-label?

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LOL, they made a product for womens eye-lashes which affects a total of 13 women but they've given a total of zero fvcks about the millions of balding men.

GREAT JOB!

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Originally Posted by Pentarou

BUMP

Whatever happened to bimatoprost as a possible new growth stimulator? Is it another premature failure?

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I'm wondering that myself.

The people who have invested a tonne of money on the off-label stuff(costs ALOT for a years supply, upwards of 1000 dollars) have actually had decent results, probably better than minoxidil.

phase II ended months ago, but still no word.

It did an awesome job on my eyebrows !!

I would love to use it on hair but cost would be immense :eek:

Even if it did the same as Minoxidil, but without the side effects, facial ageing effects and dangerous risks to the heart, it would be amazing.

maybe Desmond can find some info on this stuff? he seems to be good at finding information haha

Things have been quiet on the bimatoprost front for a while, but that was to be expected. Here are where things stand. Bimatoprost finished Phase II trials late last year, and shortly thereafter stated that they would be releasing the results of the trial at a medical conference in the second half of this year (so between June and January). No matter what, there will have to be a second clinical trial run, either a Phase III or a Phase IIa on a stronger formulation if the current one is not as effective as they want (note: they have said that they will not release a product unless it's SIGNIFICANTLY better than what's on the market). Why the delay? I'm not sure, but it's definitely not an inherently negative sign. There are SEC regulations in place about when information with significant financial consequences for a company can be released so that it doesn't give some shareholders or potential shareholders an unfair advantage, so that could be playing a role. We should know by the end of the year, good or bad.

As far as people experimenting with current or generic formulations of bimatoprost: those results are not at all representative of what the eventual product would be like. If you've read the descriptions of what they've been testing and developing, it is not at all just the active ingredient of bimatoprost: it is that ingredient AND an agent that will get it to soak into the scalp and under it to the underlying follicle. In fact, they have emphasized that it is the thick scalp skin that is presenting the main challenge. The generic formulations or Latisse do not have this agent, so it is not at all like what the proposed product would be like. Imagine if instead of swallowing a Tylenol you rubbed it on your arm; it would not be very effective. You need the medicine to get to where it needs to go to have an effect.

Thank you beetee, that explains matters somewhat. Also gives insight into why the experimental users of Bim got nowhere.

Allergan is doing another Phase II with 10x the dose, starting Q3, data maybe late next year...

Did you get this in the show last night from Joe from Staten Island?

I really hope he was right, but let's keep in mind this is more like a rumor as of right now as we have no reliable source (no offense to Joe but given the way he presented it can only be regarded that way for now) - although I definitely hope it's true!

No I got it from their earnings call this morning. Not a rumor. Stated by the company.

oh awesome! Then I'm happy this is more than a rumor and I give credit to Joe for having this news last night before the information was released to the public!

Cheers now I have to go back to pretending to work...

Interesting news!

was there any news on them releasing results of the previous phase though? I'd love to see the initial progress made.

I have some faith in this being a decent product, but would hope results support that.

rdawg, Here is the transcript from the earnings call:

So great question, and I'll give a little bit of background. So we had enough toxicology to get into the clinic at a dose similar to what was used topically. And so clearly, we wanted to get into the clinic as soon as possible, a, to see if there was a signal of efficacy. And then, two, should we have sufficient data that the efficacy was greater than generic minoxidil because our bar is high, we don't want to meet to a generic product then we would have jumped to Phase III. We did see a positive signal for hair growth. That's why we're going to do the additional Phase II work. And we knew ahead of time, as I had said previously, that we had the ability to grow substantially higher. So our new trials, we'll look at a dose approximately tenfold higher than we looked at previously in the same formulation. And we also have a novel formulation that may increase tissue exposure even a little bit higher than that. So just to summarize, you're correct. We did see some hair growth. So that there was a signal that it was growing hair but not to the sufficient amount that would warrant going into Phase III with the dose that we previously studied.

Ha, I jumped on here as soon as I got home from work thinking I'd be the first to post the info from the conference call, but look at all this activity around the news already! Guess I'm not the only one following the bimatoprost progress closely.

At first I was pretty disappointed (actually, maybe I still am disappointed) but they did say the test dose did produce results, just not as much as they (and we!) want. Don't want to look into the specific language too closely, but this seemed kind of interesting:

"And we knew ahead of time, as I had said previously, that we had the ability to grow substantially higher."

Also, I guess it's good that the next trial should be coming up soon. Guessing it will probably be completed near the end of 2013 (?). Even if so, hard to say when the results will be posted (we had to wait awhile for these results).

What do you guys think? Is this OK news, or bad news from your perspective?

Thanks Pinot for posting the response.

But it seems every viable treatment is years away from market. It's exhausting just thinking about how long we all have to wait just to try new treatments outside of Propecia/Minoxidil.

This treatment along with Histogen, Aderans etc. is years away. No hope at the moment for the near future.

The science behind bimatoprost seems really good though, which to me at least puts it pretty far ahead of treatments that's effectiveness at this point is purely theoretical.

Check out Garza's article (also known as the famous/infamous Cotsarelis article from last year) "Prostaglandin D2 Inhibits Hair Growth and Is Elevated in Bald Scalp of Men with Androgenetic Alopecia" (the parts where he talks about PGE2) as well as others, especially this one from the FASEB Journal: "The prostamide-related glaucoma therapy, bimatoprost, offers a novel approach for treating scalp alopecias.")

That being said, as long as it's years in the future it still feels like grasping at straws, and I agree it's horribly exhausting.

I don't want to look at it too closely but there's a part in the Allergan conference call when one of the executives says that bimatoprost for hair is not or was not part of their 5 year plan. Hard to know if that means they never planned it to come out within 5 years, they don't now plan on having it out in the next 5 years, or they just don't factor speculative things like that into their 5 year plan. Regardless, more waiting and patience for something that you don't even know if anything will come of it.

StayThick, Despite the many significant discoveries that have been made in the last few years that are adding bits and pieces of the puzzle, I believe you are most certainly correct that any substantial breakthru treatment that will regrow meaningful amounts of hair is years away. However, there is a realistic scenario on the horizon that you might evaluate from your own persepctive to help keep you in a positive frame of mind. S-equol will be released within the next year at the latest (and possibly this summer). At the proper dosage (as yet unknown), this has a realistic shot at shutting down the degradation process. If this does indeed result in a total shut down, it is likely that there would be some bounce back increase and thickening of existing hairs. So within a year it is a somewhat realistic proposition, that we could be in a position where we could toll any further loss. Bimatoprost would likely be the next product to market if Phase IIb tests show a substantial increase in effectiveness over minoxidil. It will likely take a year for Phase IIb and a year for Phase III, although they could begin Phase III early at the first signs of a meaningful increase in hair growth. Add a year for approval and we are likely in 2016 with a super optimistic shot at late 2015. But if s-equol comes thru we will at least be in a holding pattern until then. And given what we seem to know about how PDG2 puts the brakes on growth and counteracts the effects of hair growth stimulants like minoxidil and bimatoprost, if s-equol can reverse this drag, it is possible that the effect of any of these stimulants would be multiplied...........depending of course upon the extent of follicle degradation.

beetee133, I read "And we knew ahead of time, as I had said previously, that we had the ability to grow substantially higher." to mean that they knew that they could substantially increase the dosage rather than that they knew that they could grow substantially more hair. The response is not as clear as you would like but the next sentence goes on to say they will increase the dosage tenfold. Maybe someone will do a follow up article based on an interview w/ Alergan. Phase IIa results are certainly not as positive as you would like, but on the other hand, Allergan is a very well run company and they seem to think there is enough of a possibility of success to move forward with another trial.

PinotQ, do you know of any resources that delve into the mechanisms of S-Equol as applied to halting hair loss? This is a treatment I was excited about last year but I've not heard much lately, I believe some Aussies were marketing it but nothing came from it, right? Is that an issue of finding the correct dosage, or was theirs a bogus treatment?

Also, have you heard of the BNP-32 group buy and trial that's being undertaken in one of the private hair loss forums? Many seem to think it to be the most exciting experimental treatment yet. Any thoughts on it? It's a peptide topical, vehicle is Lubragel I believe.

Very exciting times for us baldies. Would love to halt my loss in the next year and focus on regrowth.

Conpecia, You will probably find the most detailed information on how s-equol could affect hair loss here: faqs.org/patents/app/20100076071 but add the link pre-fix. This isn't necessarily research as much as claims but among the patent's owners are Lund and Setchell who have studied s-equol at the university research level for years and probably know more than anyone about it. Just my opinion from a distance but I think the Aussie thing was a scam or at least a very very poor quality product. I do not believe you can get legitimate s-equol quite yet. The above patent suggests, based on mgs per kg of body weight, that a 190 man might need about 60 mg per day. No one knows for sure whether it will halt hairloss but it is a fact that s-equol is a powerful agonist of DHT as it binds directly to it. Whether you can economically ingest enough mgs per day for it to be effective are completely unkown. However, I suspect the mgs per kg of body weight dosage guidleine must surely come from some of their research. Other than expense, I don't think there is much downside as 60 % of Asians produce it naturally and non-western Asians are said to have a much lower incidence of mpb. Also note in the patent how s-equol affects the skin in a variety of positive ways, including the reduction of wrinkles. I believe they are seeing this in the s-equol trials..............so this is probably a good sign it could effectively do it's work in the scalp.

I know nothing about BNP-32.

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Originally Posted by Conpecia

Also, have you heard of the BNP-32 group buy and trial that's being undertaken in one of the private hair loss forums? Many seem to think it to be the most exciting experimental treatment yet. Any thoughts on it? It's a peptide topical, vehicle is Lubragel I believe.

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Being peptide based, I have doubts to whether it can penetrate the scalp with any chemical vehicle.

Anyway, unfortunate about the results so far from Allergen, but it is positive to read that the company is still set on trying to produce a superior growth stimulator.

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Originally Posted by Pentarou

Being peptide based, I have doubts to whether it can penetrate the scalp with any chemical vehicle.

Anyway, unfortunate about the results so far from Allergen, but it is positive to read that the company is still set on trying to produce a superior growth stimulator.

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By reading that it tells me they got slightly better results than minoxidil but not significant enough to go straight to III

minoxidil causes what, 10%? I'm guessing they hit 15% growth, but a higher dosage could mean 20%+, that's pretty significant.

PinotQ, you are correct about the quote from the conference call, my misunderstanding was based on an incorrect transcription from Seeking Alpha; they have it as "grow higher" when the actual content was "go higher."

One quick follow up question since you seem knowledgeable and it seems that you follow some of these things closely. Have you read the FASEB journal article study that I mentioned in a previous post in this thread, "The prostamide-related glaucoma therapy, bimatoprost, offers a novel approach for treating scalp alopecias"?

In that study the authors used Latisse, I'm pretty sure without a delivery vehicle, and they got 30% regrowth in 50% of the study participants. Granted, there are lots of factors that could have played into this (which they acknowledge in the paper), such as the area it was applied, the age of the participants, etc., but it seems somewhat strange to me that Alergan wouldn't have gotten better results than that considering that they were using a delivery vehicle. Any thoughts? Thanks.

beetee133, I read the summary of the FASEB article but the summary doesn't give much detail and doesn't talk about those percentages. Were the tests done on a human scalp? From what I know so far, it sounds like the question will come down to whether bimatoprost can overcome the countervailing effects of DHT/PDG2 and to what extent, all assuming there are sufficient quantities of follicles that haven't been damaged beyond repair. If the answer comes down in in at least some reasonably substantial way to dose dependency, then increasing the dosage and improving the vehicle may get us to the next breakthru. I have no idea what will happen but I do like Allergan and think they are a very well run company, so the fact that they think there is a possibility is at least some cause for encouragement. I also think that they will be very efficient at getting this to market quickly if there is success.

Ive got to go with what PinotQ has told us,,he is very educated on this topic! Thats the truth.

PinotQ, thanks for the response, good to hear your perspective.

As far as the article I mentioned, my bad on the title of the article. I went back and looked at the article title I referenced and that was the study where they tested it on mice and hair follicles grown in a lab (so no real humans, so significance still mostly theoretical, at least from my perspective).

There is a different article that came out in the last six months in which the authors tested it on the human scalps of younger men. The study group was not huge, I'm thinking like 30 people, and they reported results with the numbers I quoted (30% regrowth for 50% of the participants).

I have a print out of the article that I should be able to access tomorrow, and I will post the citation and some direct quotations of key portions of the study characteristics and the conclusion as soon as I can, probably tomorrow.

If you have a chance, I'd appreciate it if you could give any further impressions you have of this study once I've posted the info, and you can also feel free to ask any specific questions about the study if you have them.

The citation to the article is:

Ulrike Blume-Peytavi, Sanna Lönnfors, Kathrin Hillmann, & Natalie Garcia Bartels, “A randomized double-blind placebo-controlled pilot study to assess the efficacy of a 24-week topical treatment by latanoprost 0.1% on hair growth and pigmentation in healthy volunteers with androgenetic alopecia,” Journal of the American Academy of Dermatology, Vol. 66, Issue 5, pp. 794-800 (2012).

I have paraphrased much of the information included below to avoid violating copyright laws, but not the portion contained in quotation marks:

-The stated main objective was to assess the efficacy of latanoprost on hair growth and pigmentation. Latanoprost was chosen as representative of prostaglandin F2α analogues, with the intention of proving the concept that prostaglandins may be agents that can influence hair growth.

-The study was double-blind and randomized to assess the efficacy of a 24-week topical treatment with latanoprost 0.1% on hair growth and pigmentation in volunteers.

-The subjects were 16 male volunteers, aged 23 to 35 years, presenting a recently developed frontotemporal alopecia (Hamilton stage II-III).

-The group treated with latanprost showed some results after 12 weeks and after 24 weeks, results could be seen in 50% of this study group. “At 24 weeks at the latanoprost-treated site, the density (+22%) was significantly higher compared with baseline and placebo. As vellus hairs increased on both investigational sites, the vehicle may also have stimulated hair growth.”

Any thoughts?

Don´t understand... Did they only se results in 50% of the group? Sounds not so awesome!

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Originally Posted by eqvist

Don´t understand... Did they only se results in 50% of the group? Sounds not so awesome!

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Minoxidil is probably half that in terms of any kind of growth(and probably less than 5% see any significant growth on minoxidil, but that's just a guess)

50% is decent, apparently the trials are using a higher % dosage anyway so they should get more by the end.

I still think Bim will be a much better upgrade over Minoxidil, not giving any major NW7-NW1 benefit but something that will really help early sufferers.

Yes, they only saw results in 50 % of the group, and in that 50%, they had a little over 20 % regrowth. It's not clear, at least to me, if this regrowth was mostly due to the increasing thickness of existing hairs. However, the last part is key, in that they say that it also increased the number of vellus hairs, as this might indicate the stimulation of brand new growth, which would certainly be a very encouraging development.

However, a couple of things to keep in mind. The formula they used is the formula used to regrow eyelashes; it has no additive ingredient to get it through the thick scalp skin so it can get to the follicles (which is where it needs to go to stimulate growth). Allergan executives have stressed this in conference calls. And it is also not nearly as strong as the new mixture that Allergan will be testing out towards the end of this year. Also keep in mind that the Allergan executive in the recent conference call said that they did see regrowth from their recent tests of the basic formulation, just not enough to move forward with in regards to releasing a product. Allergan has said repeatedly that they will only release a product if it's significantly more effective than what's currently on the market.

So, I don't know. Certainly seems promising to me, but there's so much that's unknown, it's really hard to say what will come out of all this. I definitely get the sense that maybe for the first time they're really on the right path with the discovery of the role of prostaglandins, but if we're still 10-20 years out from something that would really make a meaningful difference, I'm not sure that will be of much use to a lot of us on the forum personally.

And rdawg is right that the current crop of drugs on the market have shown very little in the way of regrowth in a clinical setting. I've even seen some academic papers where they've said that they don't think minox and the others do anything at all, except in a very small portion of the population, and even then the effects are minimal. So actual regrowth in this setting is significant, even if it seems small compared to what we might ultimately want/need.

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Originally Posted by beetee133

Yes, they only saw results in 50 % of the group, and in that 50%, they had a little over 20 % regrowth. It's not clear, at least t

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That right there is huge alone, that's far more than anything today(I believe Fin+minoxdil can hit about 10%)

anything that even just reverses vellus hairs would be huge, nothing does that guarenteed right now, Fin/min do it for a select few but from what I gather BIM actually works on the hairline to a decent extent.

The issue is it's release, it probably wont be out until around histogen's release, so here we have 2 positive solutions coming out, but still 3-4 years away!

and that stupid latisse stuff is so damn expensive its not even worth trying!(10-12$ for a 4-5 day supply!)

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Originally Posted by beetee133

The citation to the article is:

Ulrike Blume-Peytavi, Sanna Lönnfors, Kathrin Hillmann, & Natalie Garcia Bartels, “A randomized double-blind placebo-controlled pilot study to assess the efficacy of a 24-week topical treatment by latanoprost 0.1% on hair growth and pigmentation in healthy volunteers with androgenetic alopecia,” Journal of the American Academy of Dermatology, Vol. 66, Issue 5, pp. 794-800 (2012).

I have paraphrased much of the information included below to avoid violating copyright laws, but not the portion contained in quotation marks:

-The stated main objective was to assess the efficacy of latanoprost on hair growth and pigmentation. Latanoprost was chosen as representative of prostaglandin F2α analogues, with the intention of proving the concept that prostaglandins may be agents that can influence hair growth.

-The study was double-blind and randomized to assess the efficacy of a 24-week topical treatment with latanoprost 0.1% on hair growth and pigmentation in volunteers.

-The subjects were 16 male volunteers, aged 23 to 35 years, presenting a recently developed frontotemporal alopecia (Hamilton stage II-III).

-The group treated with latanprost showed some results after 12 weeks and after 24 weeks, results could be seen in 50% of this study group. “At 24 weeks at the latanoprost-treated site, the density (+22%) was significantly higher compared with baseline and placebo. As vellus hairs increased on both investigational sites, the vehicle may also have stimulated hair growth.”

Any thoughts?

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Latanoprost and bimatoprost are two different but related drugs.

Latan was tested on macaques with amazing results, so it seems once again we run into the issue of why human MPB is so much less responsive to treatment than in mice or monkeys.

The bim results from Allergan are disappointing but there is a silver lining. I think the comment about "we knew we could go higher" means that by the time they finished the trial they had additional toxicology data that proved bim was safe at ten times the concentration.

Unfortunately we don't know the strength of the last trial. We know there were three different strengths and that the lowest was probably latisse ie 0.03% but no idea how high they went. But it must have been at least 0.1%, maybe as high as 0.2, which would put the new formulation at 1 to 2%. Which is massive! 30 to 60 times stronger than latisse. So if that doesn't work, nothing will.

Annoying that we need to wait another year though, for the new Phase 2. Everything just keeps slipping.

hair growth stimulators based on pgf2alpha analogues are a done deal. the hairloss community should shift their focus on other treatments.

Oppenheimer82, why do you say that? Is this based on a gut feeling you have, privileged information, or scientific studies? If scientific studies, please let us know which ones so that the rest of us can educate ourselves.

Pate, you are correct that bimatoprost and latanoprost are not the same product. As the study says, latanoprost was chosen as a representative of prostaglandin F2α analogues.

I agree that the results of the trial are frustrating and that it feels as if things could be slipping away to some extent. I also agree that there is a silver lining in that they know and have known that they could go a lot higher, so we will see if that can get better results, although like you say, we will now have to wait another year to find out.

However, I think it's worth keeping in mind the results of the study I mention, which would seem to indicate that some not insignificant hair regrowth is possible with prostaglandin F2α analogues (while the study size is small and is perhaps not representative of hair loss sufferers in general as most of the test subjects were relatively young and their hair loss began fairly recently, and the study group was fairly small at around 15 participants), and that in the conference call with Allergan in which they discussed the results of this trial they did say that they had some regrowth (we of course don't know how much or if it was clinically significant, but there being some regrowth would seem to be better than there being no regrowth).

What are the side effects of bimatoprost? Are there really facial ageing side effects and/or heart problems?