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.
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.