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R-Tech Ueno Phase II


#1

OKYO, Oct. 6 /PRNewswire/ – R-Tech Ueno, Ltd. has started early Phase II clinical trial for RK-023, a physiologically active fatty acid derivative developed by the company – a new compound targeted as a treatment for androgenetic alopecia (male pattern baldness)

Phase I clinical trial in healthy male volunteers that began in 2008 demonstrated the safety of RK-023 (Note 2). Early phase II clinical trial has been started for two purposes. One is to evaluate the safety of RK-023 for long-term use by men with pattern baldness. The other is to examine the preliminary effectiveness of this compound on hair growing. This clinical trial will be a double blind (Note 3), placebo-controlled (Note 4) study in which the study drug is applied to the scalp for 13 consecutive weeks.
“I am very pleased that early phase II clinical trial for RK-023 has started,” said Dr. Yukihiko Mashima, president of R-Tech Ueno. "This is a compound that we are developing on our own for the treatment of male pattern baldness, which is part of our core dermatology operations. We plan to proceed with development activities quickly while conducting negotiations concerning alliances with companies in Japan and overseas."
R-Tech Ueno determines to complete the development of RK-023, quickly in order to provide assistance as soon as possible to men who are troubled by the loss of hair.
Notes:
Androgenetic alopecia (male pattern baldness) is also called common baldness with aging. Following puberty, male hormones can prevent the regeneration of thick, long hair starting at the top of the skull and spreading forward. This hair is gradually replaced with thin, short hair. Eventually, this process leads to the atrophy of hair follicles and a decline in the number of strands of hair. Men first experience thinning of their hair and then baldness. This condition affects about 12 million men in Japan.
See the R-Tech Ueno press release related July 16, 2009 for more information about the Phase I clinical trial.
In a double-blind test, for the purpose of conducting the clinical trial in a completely objective manner, the physicians performing the trial as well as the patients participating in the trial do not know if the substance administered to each individual is the drug being tested or the placebo.
The placebo is a substance that does not include the drug being tested (RK-023 in this case).
About R-Tech Ueno, Ltd.

R-Tech Ueno was established in September 1989 for the purpose of marketing and R&D of drugs. Under the leadership of the CEO, also a medical doctor, the company is developing new drugs on the theme “Physician-Oriented New Drug Innovation,” targeting ophthalmologic and dermatologic diseases that previously had no effective therapeutic agent. The company’s main product Rescula® eyedrop 0.12% is a therapeutic drug for glaucoma and ocular hypertension and has been marketed in Japan since 1994. R-Tech Ueno was the first in the world to take advantage of the substance “prostone” in the development of Rescula®. Prostone was discovered in 1980 by Dr. Ryuji Ueno, the founder of the company. Rescula® eyedrop 0.12% that causes less topical and systemic adverse reactions demonstrates steady ocular pressure-decreasing action by twice-a-day instillation. Such excellent therapeutic effects are realized through its optic nerve protection and ocular blood flow-increasing mechanism.


#2

» OKYO, Oct. 6 /PRNewswire/ – R-Tech Ueno, Ltd. has started early Phase II
» clinical trial for RK-023, a physiologically active fatty acid derivative
» developed by the company – a new compound targeted as a treatment for
» androgenetic alopecia (male pattern baldness)
»
»
» Phase I clinical trial in healthy male volunteers that began in 2008
» demonstrated the safety of RK-023 (Note 2). Early phase II clinical trial
» has been started for two purposes. One is to evaluate the safety of RK-023
» for long-term use by men with pattern baldness. The other is to examine the
» preliminary effectiveness of this compound on hair growing. This clinical
» trial will be a double blind (Note 3), placebo-controlled (Note 4) study in
» which the study drug is applied to the scalp for 13 consecutive weeks.
» “I am very pleased that early phase II clinical trial for RK-023 has
» started,” said Dr. Yukihiko Mashima, president of R-Tech Ueno. “This is a
» compound that we are developing on our own for the treatment of male
» pattern baldness, which is part of our core dermatology operations. We plan
» to proceed with development activities quickly while conducting
» negotiations concerning alliances with companies in Japan and overseas.”
» R-Tech Ueno determines to complete the development of RK-023, quickly in
» order to provide assistance as soon as possible to men who are troubled by
» the loss of hair.
» Notes:
» Androgenetic alopecia (male pattern baldness) is also called common
» baldness with aging. Following puberty, male hormones can prevent the
» regeneration of thick, long hair starting at the top of the skull and
» spreading forward. This hair is gradually replaced with thin, short hair.
» Eventually, this process leads to the atrophy of hair follicles and a
» decline in the number of strands of hair. Men first experience thinning of
» their hair and then baldness. This condition affects about 12 million men
» in Japan.
» See the R-Tech Ueno press release related July 16, 2009 for more
» information about the Phase I clinical trial.
» In a double-blind test, for the purpose of conducting the clinical trial
» in a completely objective manner, the physicians performing the trial as
» well as the patients participating in the trial do not know if the
» substance administered to each individual is the drug being tested or the
» placebo.
» The placebo is a substance that does not include the drug being tested
» (RK-023 in this case).
» About R-Tech Ueno, Ltd.
»
» R-Tech Ueno was established in September 1989 for the purpose of marketing
» and R&D of drugs. Under the leadership of the CEO, also a medical doctor,
» the company is developing new drugs on the theme “Physician-Oriented New
» Drug Innovation,” targeting ophthalmologic and dermatologic diseases that
» previously had no effective therapeutic agent. The company’s main product
» Rescula® eyedrop 0.12% is a therapeutic drug for glaucoma and ocular
» hypertension and has been marketed in Japan since 1994. R-Tech Ueno was the
» first in the world to take advantage of the substance “prostone” in the
» development of Rescula®. Prostone was discovered in 1980 by Dr. Ryuji
» Ueno, the founder of the company. Rescula® eyedrop 0.12% that causes less
» topical and systemic adverse reactions demonstrates steady ocular
» pressure-decreasing action by twice-a-day instillation. Such excellent
» therapeutic effects are realized through its optic nerve protection and
» ocular blood flow-increasing mechanism.

Interesting. I’ve never heard of this before though … is it a DHT blocker? Growth stimulant? Both?


#3

Nice to see more companies starting phase 2 trails …

interestingly, in their July 2009 press release they stated, “We are pleased to announce the successful completion of a phase 1 clinical study on our self-developed RK-023 that focuses on the dermatology field. We intend to start a phase 2 clinical study in Japan as scheduled and at the same time proceed with full-scale negotiations for partnership at home and abroad.”"


#4

» R-Tech Ueno determines to complete the development of RK-023, quickly in
» order to provide assistance as soon as possible to men who are troubled by
» the loss of hair.

I like this quote quite a bit.
Of course, I’d like it even more if they shared their proof of concept with the public.


#5

» » R-Tech Ueno determines to complete the development of RK-023, quickly in
» » order to provide assistance as soon as possible to men who are
» troubled by
» » the loss of hair.
»
» I like this quote quite a bit.
» Of course, I’d like it even more if they shared their proof of concept
» with the public.

They say phase II will be a 13-week test. We should hear something by the March-ish next year then I suppose (given a couple of months for them to examine the results).

If does have some kind of positive effect it should be pretty easy to import from Japan even if they don’t find a US distributor/partner right away.

They are more likely to be in a rush to get this thing to market because they need a money-making product in the midst of this economic downturn moreso than concern for balding men, but hey … whatever works, lol.


#6

when i hear fatty acides then antiandrogen properties come to mind.I think revivogen that is supposed to be a topical antiandrogen has fatty acids.Maybe its a superstrong compound or something who knows.

But if it is an antiandrogen topical or not, due to transdermal delivery, nasty sides comes to mind :frowning: …i hope its not an antiandrogen we need our mojo along with our hair. and even for people that dont suffer sides i dont see anyhting better than propecia coming along from this route…


#7

» and even for people that dont suffer sides i dont
» see anyhting better than propecia coming along from this route…

This is one of those things that is never gonna be understood by most of the crowd.

Every time a new androgen-fighting method is discussed, everyone starts asking if it’ll regrow a bunch of hair.


#8

» » and even for people that dont suffer sides i dont
» » see anyhting better than propecia coming along from this route…
»
» This is one of those things that is never gonna be understood by most of
» the crowd.
»
» Every time a new androgen-fighting method is discussed, everyone starts
» asking if it’ll regrow a bunch of hair.

There’s a fairly big difference between a topical anti-androgen that competes with DHT to bind with the hair shaft and what Propecia does.

Cosmo Pharmaceuticals is also in phase II of a topical anti-androgen that has virtually no systemic side effects and is even more potent than flutamide/propecia. I would keep an eye out for that one also.


#9

» There’s a fairly big difference between a topical anti-androgen that
» competes with DHT to bind with the hair shaft and what Propecia does.
»
» Cosmo Pharmaceuticals is also in phase II of a topical anti-androgen that
» has virtually no systemic side effects and is even more potent than
» flutamide/propecia. I would keep an eye out for that one also.

I hope you are right and that is the case but even propecia is supposed to give sides to 1-2% of the users and that doesnt seem to be the case in reality. I dont like the antiandrogen route for me is primitive is like my arm hurts then i cut down my arm philosophy. You cant play with hormones just for shake of hair, they are essential for our balance and unforunately for our “hydraulics” as men. I dont trust any andiandrogen i think even the supposedly safest ones can cause many problems.

Personally after what propecia did to me when i was taking it i am not gonna touch another antiandrogen until i hear peoples reviews in these boards.And if suddenly people appear with sides and everyone starts to call them crazy as they did years ago in these forums with people who had sides from propecia…then i am not gonna touch it whatever it will be.


#10

»
» I hope you are right and that is the case but even propecia is supposed to
» give sides to 1-2% of the users and that doesnt seem to be the case in
» reality. I dont like the antiandrogen route for me is primitive is like my
» arm hurts then i cut down my arm philosophy. You cant play with hormones
» just for shake of hair, they are essential for our balance and unforunately
» for our “hydraulics” as men. I dont trust any andiandrogen i think even the
» supposedly safest ones can cause many problems.
»
» Personally after what propecia did to me when i was taking it i am not
» gonna touch another antiandrogen until i hear peoples reviews in these
» boards.And if suddenly people appear with sides and everyone starts to call
» them crazy as they did years ago in these forums with people who had sides
» from propecia…then i am not gonna touch it whatever it will be.

I don’t think the side effect issues with Propecia can be compared to any of the topical AAs that are “no sides.”

Finasteride works throughout the entire body in a totally indiscriminate manner. There is nothing about the drug’s action that makes it act in the scalp any more than it acts on your penis or your elbow. The only reason that the side effects were supposed to be minor was becuase the reserchers believed that the hormone being suppressed was not very important. (yeah, right.)

The “no sides” topical AAs work differently. They suppress all androgens (not just type#2 DHT like Finasteride). This would give everyone huge obvious side effects if it was acting throughout your body. But the point of a topical AA is that it is made to degrade into something radically weaker almost instantly upon entering the body. Its power is only working at full strength in the immediate area where it first hit the skin.


#11

»
»
» Finasteride works throughout the entire body in a totally indiscriminate
» manner. There is nothing about the drug’s action that makes it act in the
» scalp any more than it acts on your penis or your elbow. The only reason
» that the side effects were supposed to be minor was becuase the reserchers
» believed that the hormone being suppressed was not very important. (yeah,
» right.)
»
»
» The “no sides” topical AAs work differently. They suppress all androgens
» (not just type#2 DHT like Finasteride). This would give everyone huge
» obvious side effects if it was acting throughout your body. But the point
» of a topical AA is that it is made to degrade into something radically
» weaker almost instantly upon entering the body. Its power is only working
» at full strength in the immediate area where it first hit the skin.

transdermal delivery is not to be underestimated. even pregnant women cannot handle broken propecia tablets because it might affect the genitalia in male babys.

I dont know if the sides from topical are not existant i highly doubt that (not that i have tried anything that worked even close to propecia and i have tried spiro cream and revivogen) i dont remember any sides but i dont remember any results worth mentioning also. but i have heard of many topicals and people saying that stopped them because they because they had sides (flutamide,ru etc)…same like propecia others had sides others not.

I dont know cal if something comes up that will really only work topically and it will dissapear before it makes any other damage it would be good i guess. But i highly doubt it, these things even if they work topically it means that they are killing DHT and the body understands that and will try to compensate for the lost DHT by raising testosterone and then excess testosterone might turn to estradiol and blah blah blah and then hormonal imbalances that lead many people to weird sides might start again


#12

You may never get a perfect zero-sides topical that is also very highly effective. But I’m not so sure that is a very realistic goal either.

I use Fluridil and get no detectable sides whatsoever. It doesn’t seem to be doing a whole lot but it does something.

I also use lavender oil bodywash on my head and I can detect no sides whatsoever. It does a small amount (but something) too.

The users of RU seem to come back saying that there can be sides if you use a ton of it, but not when you keep the dosage reasonable. I believe that.

If a reasonable dosage of something as powerful as RU is not enough to stop/slow your loss, then honestly I don’t think there’s a whole lotta point in chasing the issue much farther.

There are some severely-balding guys on big daily doses of Dutasteride and they still don’t stop losing hair. What’s the point of trying even harder to stop androgenic activity when a step THAT drastic hasn’t worked for them? Their hair’s androgenic susceptibility is obviously so intense that I don’t think anything is going to stop that freight train of loss. At least nothing within practical reason.

Our true freedom from MPB doesn’t lie in anything that stops androgens better. It lies in a commercially viable HM method. Androgen stopping helps slow the progression but that particular angle has never be the whole story of MPB.


#13

(bumping roger_that’s threads off the bottom of the page)