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Y’s Therapeutics Announces Acceptance of CTA to conduct Phase I/II Clinical
Trial of YSCMA in France
Tokyo, Japan, and Burlingame, CA – November 5, 2008 -
Y’s Therapeutics, a privately held biopharmaceutical company, announced today that its Clinical Trial Authorization (CTA)
for YSCMA has been accepted by the French Agency for the Safety of Health Products (AFSSAPS).
This authorization permits Y’s Therapeutics to initiate a Phase I/II clinical trial of YSCMA for the treatment of
CD26-positive malignant mesothelioma and other CD26-positive solid tumors.
YSCMA is a humanized anti-CD26 therapeutic antibody targeted for the treatment of CD26-positive solid tumors. The target antigen,
CD26 is a transmembrane glycoprotein expressed on several normal tissues and some solid tumors such as malignant mesothelioma,
lung, liver, and prostate cancers. High expression of CD26 in malignant mesothelioma caused by asbestos exposure suggests
it is promising therapeutic target. The results of pre-clinical animal studies show no significant safety risk and clear
anti-tumor efficacy on solid tumors such as malignant mesothelioma and renal carcinoma as well as hematological malignancies
such as T-cell lymphoma.
The Phase I/II clinical study is planned to be conducted at 2 sites in France, and will be initiated in December 2008.
“Malignant mesothelioma, caused by past exposure to asbestos, is a significant medical problem facing society not only in
Japan but also all over the world. YSCMA has demonstrated substantial anti-tumor effects in preclinical animal models,
and we hope to bring this drug to patients as soon as possible. We plan to expand clinical development to additional
indications in the future, as CD26 expression is common in a variety of other cancers where there exists a significant
unmet medical need.” said CEO Masanori Murayama.
About Y's Therapeutics
Y's Therapeutics (http://www.ysthera.com) is a privately held biopharmaceutical company engaged
in the R&D of novel therapeutics for the treatment of inflammation-mediated diseases, cancer, and other unmet medical needs.
Y's focuses on the development of preclinical and early-stage clinical projects pursued through research collaborations and
in-licensing opportunities from academic institutions and biotech companies. Y's is seeking collaborative relationships,
including out-licensing of product rights and creation of joint ventures, for late-stage development,
manufacturing and commercialization of its portfolio products. The company currently has several projects
in its clinical and preclinical pipeline. Y's has operations in two locations, Y's Therapeutics Co., Ltd.,
of Tokyo, Japan, and Y's Therapeutics, Inc., of Burlingame, CA.
Y's Therapeutics Co., Limited (Symbol: Private)
Fujiwara Building, 4F, 1-10-11 Ebisu-Nishi, Shibuya-ku Tokyo
Japan, 150-0021
http://www.ysthera.com
| ◈U.S. CONTACT◈ Scott McNinch Director of Business Development, Y's Therapeutics, Inc. +1-650-777-7029 bizdev@ysthera.com |
◈JAPAN CONTACT◈ Yoshio Hioki Director of IP / Licensing & Planning Department, Y's Therapeutics, Co., Ltd. +81-3-5784-2762 bizdev@ysthera.com |
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