bimatoprost

[rdawg]

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.

[PinotQ]

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.

[beetee133]

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?

[StayThick]

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.

[beetee133]

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.

[PinotQ]

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.

[Conpecia]

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.

[PinotQ]

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.

[Pentarou]

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.

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.

[rdawg]

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.

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.

[beetee133]

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.

[PinotQ]

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.

[Artista]

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

[beetee133]

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.

[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?