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R-Tech Ueno: Announcement of Initiation of the Phase I Clinical Trial for the Novel VAP-1 Inhibitor RTU-1096

2014年10月20日 PM03:51
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TOKYO

R-Tech Ueno (JASDAQ: 4573):

We are pleased to announce that as of today, the company has started the phase one clinical trial for the new molecular entity RTU-1096, which is a vascular adhesion protein-1 (VAP-1) inhibitor having anti-inflammatory and immunomodulatory effects. The descriptions are as follows:

The company has developed the anti-inflammatory drug with a new mechanism of action based on the VAP-1 inhibitory effect. At present, the company has started the phase I clinical trial for the oral agent of a new molecular entity (Development Code: RTU-1096) targeted at healthy male adults. This trial is intended to examine the safety, tolerability, and pharmacokinetics of the inhibitor with a single dose. The trial would be conducted as a placebo-controlled, double-blind, dose-escalation study complied with the Good Clinical Practice (GCP).

Dr. Yukihiko Majima, President of the company, has stated as follows:
“RTU-1096 is a new molecular entity for first-in-human use. After its safety and tolerability with a single dose are confirmed, we would further examine its safety, tolerability, and pharmacokinetics with repeated doses. If its safety and tolerability are confirmed through the phase I clinical trial, RTU-1096 would be one of the promising treatment candidates for diseases with unmet medical needs (medical areas where satisfying treatment is not yet established), which is what the company is focused on. The current candidate diseases for RTU-1096 are dermatological diseases such as atopic dermatitis and psoriasis. These diseases have been treated mainly with ointments such as steroids, and there are concerns regarding side effects due to long-term administration and the burden of daily application. RTU-1096 has a new mechanism of action; therefore, we believe that it will possibly be effective for patients in whom the existing treatment is not sufficiently effective. In addition, by providing RTU-1096 as an oral agent, we expect that it would improve the quality of life (QOL) of patients and reduce the burden on the patients’ families.”

The above venture will not contribute to any revision of the full-year earnings estimates pre-announced on May 14, 2014.

For full details of the press release, please visit:
http://www.rtechueno.com/en/investor/press/documents/141020_pr_en.pdf

CONTACT

R-Tech Ueno, Ltd.
Koji Nakamura, +81-3-3596-8011
Director
Business
Management Department
info@rtueno.co.jp

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