December 9, 2013

Ono Pharmaceutical Co., Ltd.

OncoTherapy Science, Inc.

Clinical Trial Application submitted for Phase I study of ONO-7268MX2, peptide-cocktail vaccine for hepatocellular carcinoma

Ono Pharmaceutical Co., Ltd (Head office: Chuo-ku, Osaka, President and Representative Director: Gyo Sagara, "Ono") today announced that Ono has submitted Clinical Trial Application for Phase I study for ONO-7268MX2, a product containing in-licensed peptide vaccines for hepatocellular carcinoma. The vaccines were in-licensed from OncoTherapy Science Inc. (Head office: Kawasaki-city, President & CEO: Takuya Tsunoda).
The aim of this clinical study is to evaluate safety and immune response when ONO-7268MX2 is administered to hepatocellular carcinoma patients who are refractory or intolerant to standard therapies.
Hepatocellular carcinoma accounts for 90% of primary hepatic cancer in Japan1) and approximately 30
thousands patients reportedly die annually2). Meanwhile, as treatments for hepatocellular carcinoma, surgical treatments such as hepatic resection, radiofrequency ablation and/or percutaneous ethanol injection are performed as well as chemotherapy and/or radiotherapy, however the prognosis is still poor and novel treatment has been desired.
ONO-7268MX2 is a cocktail vaccine which contains multiple epitope peptides derived from oncoantigens specifically expressed in hepatocellular carcinoma as active ingredients, and is strongly expected to show anti-tumor activity by inducing the cytotoxic T cells specific to hepatocellular carcinoma. This clinical study is going to evaluate the safety of ONO-7268MX2 as well as the immune response induced by the vaccine and will lead to the subsequent phase of the clinical study.

1) Liver Cancer Study Group of Japan. Report of the 18th Nationwide Follow-up Survey of Primary

Liver Cancer in Japan (2004 - 2005). 2009

2) Foundation for Promotion of Cancer Research. Cancer statistics in Japan-2012.


Contacts
Ono Pharmaceutical Co., Ltd. Corporate Communications
+81-6-6-6263-5670
Yukio Tani y.tani@ono.co.jp
OncoTherapy Science, Inc. Management & Controlling Division
+81-6-44-820-8251
Kazuo Yamamoto info@oncotherapy.co.jp

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