SillaJen Enrolls First U.S. Patient in Multinational Phase 3 Trial for Pexa-Vec in Advanced Liver Cancer

SAN FRANCISCO, March 29, 2016 /PRNewswire/ -- SillaJen, Inc., a private, clinical-stage, biotherapeutics company focused on the development of oncolytic immunotherapy products for cancer, has enrolled the first U.S. patient in its ongoing multinational randomized Phase 3 open-label study of its lead product candidate, Pexa-Vec (formerly JX-594), in patients with advanced liver cancer, also known as hepatocellular carcinoma (HCC). The trial is evaluating the use of Pexa-Vec to treat HCC patients who have failed locoregional therapies and are eligible for treatment with sorafenib (Nexavar®), the only approved drug for advanced HCC. The U.S. patient was enrolled at the University of Tennessee Medical Center in Knoxville, Tennessee.

The study, named the PHOCUS trial, is designed to enroll 600 patients who have not received prior systemic treatment for their cancer, and they will be randomized to one of two treatment groups: one which will receive Pexa-Vec followed by sorafenib and one which will receive sorafenib alone. The randomized study will be conducted at approximately 140 sites worldwide including North America, Asia, Australia, and Europe. SillaJen reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for this global Phase 3 clinical trial. The primary objective of the study will be to determine the overall survival of patients treated with Pexa-Vec, followed by sorafenib versus sorafenib alone. Secondary objectives will include safety as well as assessments for tumor responses between the two groups as measured by the following endpoints: time to progression, progression-free survival, overall response rate and disease control rate. To learn more about the trial, please visit: http://www.pexavectrials.com/.

"Primary liver cancer remains an unmet medical need for thousands of newly diagnosed patients and their families.  We hope that the initiation of the PHOCUS clinical trial in New Zealand and the United States is an early step toward developing a new treatment for this disease.  SillaJen is committed to completing this pivotal clinical trial with start-up and enrollment activities ongoing at sites around the world.  We are honored to be working with such a committed team of world-class global investigators," stated Eun Sang Moon, chief executive officer of SillaJen.

"It is quite promising to see the first patient enrolled in PHOCUS in the US.  HCC is obviously a disease where innovative treatment options such as Pexa-Vec are needed," stated Ghassan Abou-Alfa, M.D. medical oncologist at Memorial Sloan Kettering Cancer Center and lead investigator on the Phase 3 trial.  "Having been involved in a prior clinical trial using Pexa-Vec, I remain excited about the potential this new cancer immunotherapy holds.  Options for patients with advanced HCC are currently very limited. I'm pleased to have the opportunity to enroll in this trial, with the hope that our team can contribute to expanding options for patients with hepatocellular carcinoma. The University of Tennessee is at the forefront of bringing innovative cancer treatments to patients as exemplified by having enrolled the first North American patient into the PHOCUS trial," added Laura Findeiss, M.D., professor of interventional radiology and chair, Department of Radiology.

Pexa-Vec Clinical Development Program and SOLVE Platform
Pexa-Vec is the most advanced product candidate from SillaJen's proprietary SOLVE™ (Selective Oncolytic Vaccinia Engineering) platform. The vaccinia strain backbone of Pexa-Vec has been used safely in millions of people as part of a worldwide vaccination program. This strain naturally targets cancer cells due to common genetic defects in cancer cells; Pexa-Vec was engineered to enhance this by deleting its thymidine kinase (TK) gene, thus making it dependent on the cellular TK expressed at persistently high levels in cancer cells. Pexa-Vec is also engineered to express the immunogenic GM-CSF protein. GM-CSF complements the cancer cell lysis of the product candidate, leading to a cascade of events resulting in tumor necrosis, tumor vasculature shutdown and sustained anti-tumoral immune attack.

About SillaJen's Regional Partners for Pexa-Vec

About Transgene
Transgene S.A. (Euronext: TNG), part of Institut Mérieux, is a publicly traded French biopharmaceutical company focused on discovering and developing targeted immunotherapies for the treatment of cancer and infectious diseases. Transgene's programs utilize viral vector technology with the goal of indirectly or directly killing infected or cancerous cells. The Company's two lead clinical-stage programs are: TG4010 for non-small cell lung cancer and Pexa-Vec for liver cancer. The Company has several other programs in clinical and pre-clinical development. Transgene is based in Strasbourg, France, and has additional operations in Lyon, as well as satellite offices in China and the U.S.  Additional information about Transgene is available at www.transgene.fr.

About Lee's Pharma
Lee's Pharmaceutical Holdings Limited is a research-based biopharmaceutical company listed in Hong Kong with over 20 years operation in China's pharmaceutical industry. It is fully integrated with strong infrastructures in drug development, manufacturing, sales and marketing. It has established extensive partnership with over 20 international companies and currently has 14 products in the market place. Lee's focuses on several key disease areas such as cardiovascular, oncology, gynecology, dermatology and ophthalmology. Lee's development program is lauded with 47 products stemming from both internal R&D efforts and collaborations with US, European and Japanese companies and aspiring to combat diseases such as liver cancer and pulmonary hypertension. The mission of Lee's is to become a successful biopharmaceutical group in Asia providing innovative products to fight diseases and improve health and quality of life. Additional information about Lee's Pharmaceutical is available at www.leespharm.com.

About SillaJen
SillaJen, Inc. is a South Korean based biotechnology company headquartered in Busan South Korea, with satellite offices in Seoul, South Korea and San Francisco, CA.  The company is focused on the development and commercialization of oncolytic immunotherapy products using the SOLVE^TM platform, including its lead product Pexa-Vec, which is currently in Phase 3 trials for the treatment of advanced primary liver cancer. Additional information about SillaJen is available at www.sillajen.com.

SOURCE SillaJen, Inc.

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