Navigation Links
R-Tech Ueno, Ltd. Completes Phase 1 Clinical Study on RK-023

TOKYO, July 21 /PRNewswire/ -- R-Tech Ueno, Ltd. announced on July 17 that as a phase 1 clinical study on the new compound RK-023 that is being developed by our company as a therapeutic drug of androgenetic alopecia (male pattern baldness; see the note below) has been completed.

The phase 1 clinical study of RK-023 consisted of a patch test (open, closed, photo-patch test), single-dose study and 5-day repeated-dose study. Since no serious adverse event occurred in each test, RK-023 seems to hardly cause any safety problem in the human body.

As the first step, patch tests were conducted to obtain data on skin irritation. Using RK-023 preparation and a placebo, the tests were conducted on 20 healthy adult males by the following 3 methods and the results were evaluated.

    (1) Open patch test: Open patch dressing to the forearm skin for 48 hours
    (2) Closed patch test: Closed patch dressing to the back skin for 48 hours
    (3) Photo-patch test: Closed patch dressing to the back skin for 24 hours,
        followed by UVA irradiation

No adverse event occurred and the resulting irritation was negligible in each test.

As the next step, single and 5-day repeated applications of RK-023 preparation to the scalp were conducted by a randomized, placebo-controlled, double blind method to evaluate the safety and pharmacokinetics of the drug. In the single-dose study, 2 ml of RK-023 preparation was applied to the vertex region of 6 out of 9 healthy adult males and a placebo to that of the remaining 3 subjects. The applied drug was spread widely covering the vertex region in order to investigate the safety in the entire body and scalp. No serious adverse event occurred. After application of the drug, blood and urine were collected in the lapse of time to determine drug concentrations. However, the drug concentration was below the quantification limit at any of the prescribed time points. In the 5-day repeated-dose study, in the morning and at night 2 ml of RK-023 preparation or 2 ml of placebo was applied to 6 and 2 out of 8 healthy adult males respectively. No serious adverse event was observed during the total 9 times of application up to the morning of day 5. When the drug concentration in the blood was measured, the level was below the quantification limit as in the case of the single-dose study.

As described above, percutaneous absorption of the drug was not high even after continuous application in the morning and at night for 5 days, suggesting hardly any safety problem.

Yukihiko Mashima, Representative Director and President of R-Tech Ueno, commented as follows. "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."

Having obtained the results of the above-mentioned phase 1 clinical study, we plan to promptly conduct a phase 2 clinical study and accelerate our efforts to develop a drug that will become useful for the patients with androgenetic alopecia as soon as possible.

Note: Androgenetic alopecia:

Due to the influence of male hormones during and after puberty, thick and long hair does not regenerate but is replaced with thin and short soft hair, and consequently the hair follicles become atrophied, reducing the quantity of hair, localized from the parietal to the frontal region.

*About R-Tech Ueno, Ltd.

R-Tech Ueno was established in September 1989 for the purpose of marketing and R&D of drugs. Led by Dr. Yukihiko Mashima, Representative Director and President of R-Tech Ueno, this pharmaceutical venture enterprise has been engaged in the development of new drugs under the theme of "Physician-Oriented New Drug Innovation" and has targeted at ophthalmologic and dermatological diseases against which effective drugs are hard to come by. 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) eyedrop 0.12%. Prostone was discovered in 1980's 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. Concerning Rescula(R) (isopropyl unoprostone) for the treatment of glaucoma and ocular hypertension, R-Tech Ueno concluded a contract with Sucampo Pharma Americas, Inc. in April 2009 for the approval and assignment of distributorship, as well as for licensing the relevant patents and granting exclusive rights to manufacture and supply in USA and Canada.

    CONTACT:  Koji Nakamura
    IR Department,
    Business Management Department,
    R-Tech Ueno, Ltd.
    Phone: +81-3-3596-8011

SOURCE R-Tech Ueno, Ltd.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Idenix Pharmaceuticals Successfully Completes Proof-of-Concept Study of IDX184 for the Treatment of Hepatitis C Virus (HCV)
2. Osteotech Completes Enrollment for DuraTech(TM) BioRegeneration Matrix Clinical Trial
3. Novavax Completes Enrollment of Its Second Phase II Seasonal Influenza VLP Vaccine Clinical Trial
4. Potentia Pharmaceuticals POT-4 Drug Candidate for Age-Related Macular Degeneration Successfully Completes Phase I Clinical Trial - Prepares for Phase II
5. Peregrine Pharmaceuticals Completes Patient Enrollment in its Phase II Trial of Bavituximab Plus Docetaxel in Breast Cancer Patients
6. QRxPharma Successfully Completes Comparative Study for Dual-Opioid(TM) Pain Therapy
7. Major Restless Legs Study Completes Enrollment With Support From MediciGlobal
8. QuatRx Completes Enrollment of Ophena(TM)(Ospemifene Tablets) Final Pivotal Phase 3 Study in Women with Postmenopausal Vaginal Atrophy
9. Poniard Completes Patient Enrollment Target in Phase 3 SPEAR Trial of Picoplatin in Small Cell Lung Cancer
10. ThromboGenics Completes Patient Enrolment for Phase II Trial of Microplasmin for the Treatment of Diabetic Macular Edema (MIVI II DME)
11. ADVENTRX Completes Patient Enrollment in ANX-514 Bioequivalence Study
Post Your Comments:
(Date:6/24/2016)... -- According to a new market research ... Safety Pen Needles), Needle Length (4mm, 5mm, 6mm, 8mm, ... Purchase (Retail, Non-Retail) - Trends & Global Forecasts to ... for the forecast period of 2016 to 2021. This ... 2021 from USD 1.65 Billion in 2016, growing at ...
(Date:6/23/2016)... Research and Markets has announced the addition of the ... report to their offering. ... failure, it replaces the function of kidneys by removing the ... the treatment helps to keep the patient body,s electrolytes such ... Increasing number of ESRD patients & substantial healthcare expenditure on ...
(Date:6/23/2016)... Research and Markets has announced the addition of ... Forecast to 2022" report to their offering. ... date financial data derived from varied research sources to present ... impact on the market during the next five years, including ... sub markets, regional and country level analysis. The report provides ...
Breaking Medicine Technology:
(Date:6/26/2016)... Aliso Viejo, California (PRWEB) , ... June 26, 2016 , ... ... for Final Cut Pro X. , "Film editors can give their videos a whole ... artistically," said Christina Austin - CEO of Pixel Film Studios. , ProSlice Levels ...
(Date:6/26/2016)... ... June 26, 2016 , ... Many women ... diagnosed with endometriosis. These women need a treatment plan to not only alleviate ... that can help for preservation of fertility and ultimately achieving a pregnancy. The ...
(Date:6/25/2016)... Miami, FL (PRWEB) , ... June 25, 2016 , ... The temporary closing of Bruton ... Plant City Observer , brings up a new, often overlooked aspect of head lice: ... The closing for fumigation is not a common occurrence, but a necessary one in the ...
(Date:6/25/2016)... ... June 25, 2016 , ... As a lifelong Southern Californian, Dr. Omkar ... M.D from the David Geffen School of Medicine at UCLA. He trained in Internal ... complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where he had ...
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the benefits of moderation, ... the latter, setting the bar too high can result in disappointment, perhaps even self-loathing. ... toward their goal. , Research from reveals that behind the ...
Breaking Medicine News(10 mins):