Japan's First Anti-cancer Adenovirus Is Now GO for Clinical Studies in US

www.oncolys.com PRESS RELEASE AUGUST 25, 2006 ONCOLYS BIOPHARM A INC. Japan’s First Anti-cancer Adenovirus is now GO for clinical studies in US Tokyo, Japan, August 25, 2006 --- Oncolys BioPharma (Tokyo, Japan, President & CEO, Yasuo Urata) announces that the company has obtained an FDA’s approval by which the company ca n commence the Phase I clinical t rial in which the patients with solid cancers will be receiving the viral treatment with Telomelysin or OBP301. The company submitted the IND t o FDA in March this year and the authority has held its appr oval until the company responded to the issues raised by the authority. As the company’s responses are all accepted by the company, T elomelysin i s now th e f irst Jap anese adenovirus which enters a clinical evaluation in USA. The Phase I study will enroll the patients with solid tumors who have been resistant to the existing or conventional therapy and who have no other good alternatives. The first patient is expected to receive the trial medication before October in the Mary Crowly Medical Research Center, Dallas of T exas in the United States. Th e company also expects that the study will be completed by the end of 2007. About Telomelysin: Telomelysin is a novel, conditional-restricted, replication-competent adenovirus. Through a novel vector approach, a transcriptional element of the E1A adenovirus gene, which plays a significant role in replication, has been replaced by an inserted huma n telomerase reverse transcriptase (hTERT) gene promoter sequence (Fig1). The hTERT is one of the components of Telomerase, of which expression is up-regulated exclusively in tumor cells. The enzyme is expressed in approximately 90% of all types of cancer cells. Telomelysin is able to achieve a high replication rate due to Internal Ribosome Binding Site (IRES) gene inserted between E1A and E1B genes. With th e s aid unique features , Telomelysin replicates in cancer cells and such replication l eads to cell deat h, but replication is restrict ed in normal cells lacking Telomerase activity, resulting in little damage (Fig 2). Oncolys has already complete d preclinical studies which has shown hi gh anti-tumor efficacy on human tumor without any abnor mal findings. The early animal studies 1/3 www.oncolys.com demonstrated that human colon cancer cells t ransplanted and grown in mice w ere destroyed 15 days after Telomelysin was injected. The anti-cancer treatment using Telomelysin is expected to have high efficacy with low adverse effects as it works specifically on the cancer cells. Therefore, patients treated with Telomelysin could get reli ef from seve re a dverse effects normally seen with t he existing and conventional therapies, and co uld eventually enjoy better quality of li fe (QOL). Fig. 1 Adenovirus Type 5 E1A hTERT promoter IRES E1B 455bp 911bp 605bp 1836bp Total 3843bp ϶E1 ϶E3 ITR ITR Adenovirus Type 5 E1A hTERT promoter IRES E1B 455bp 911bp 605bp 1836bp Total 3843bp ϶E1 ϶E3 ITR ITR E1A hTERT promoter IRES E1B 455bp 911bp 605bp 1836bp Total 3843bp ϶E1 ϶E3 ITR ITR Fig. 2 Normal Cells Cancer Cells No Damage On Normal Cells Cell Killing And Virus Spread No Viral Replication ʢTelomerase activity +ʣ ʢTelomerase activity ʵʣ Normal Cells Cancer Cells No Damage On Normal Cells Cell Killing And Virus Spread No Viral Replication ʢTelomerase activity +ʣ ʢTelomerase activity ʵʣ 2/3 www.oncolys.com About Oncolys BioPharma Inc. http://www.oncolys.com The company was founded in March 18, 2004. The early business ob jective is t o d evelop a nd com mercialize a ne wly d iscovered oncolytic virus “Telomelysin” which is a joint invention by Professor Noriaki Tanaka and Associate Professor Toshiyoshi Fujiwara of Okayama University. The company has added ‘infectious disease’ as its strategic franchise and concluded an exclusive license agreement with Yale University on behalf of Professor Masanori Baba of Kagoshi ma Univers ity and Professor Hi romichi T anaka of Show a Universit y in Japan, and Yung-Chi Cheng of Yale University School of Medicine, for a novel anti-HIV candidate t herapeutic agent. The agreement will grant Oncolys BioPharma a global exclusive right of clinical and business development. President and CEO: Yasuo Urata Headquarters: 3-16-33 Roppongi, Minato-ku, Tokyo 106-0032, Japan Capital: ¥1,058.2 million Contact Oncolys BioPharma Inc. Address: 3-16-33 Roppongi, Minato-ku, Tokyo 106-0032, Japan Telɿ+81-3-5575-3378 Fax: +81-3-5575-0488 E-mailɿ[email protected] 3/3

The release as fetched from its publisher. oncolys.com ↗