MEDIA RELEASE PR36435
R-Tech Ueno Starts Early Phase II Clinical Trial for RK-023
TOKYO, Oct. 6 /Kyodo JBN-AsiaNet/--
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) (Note 1).
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:
1. 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.
2. See the R-Tech Ueno press release related July 16, 2009 for more
information about the Phase I clinical trial.
3. 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.
4. 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(R) 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(R). Prostone was discovered in 1980 by Dr. Ryuji Ueno, the
founder of the company. Rescula(R) 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.
Stock Code: No.4573, Osaka Securities Exchange; Hercules
Head Office: 1-1-7 Uchisaiwai-cho, Chiyoda-ku, Tokyo
Representative Director & President: Yukihiko Mashima
Source: R-Tech Ueno, Ltd.
Contact:
Koji Nakamura,
Business Management Department
R-Tech Ueno, Ltd.
Tel: +81-3-3596-8011
e-mail: koji.nakamura@rtueno.co.jp
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