SillaJen Announces Conclusions From Interim Futility Analysis Of Phase 3 PHOCUS Trial in HCC

SEOUL, South Korea and SAN FRANCISCO, Aug. 2, 2019 /PRNewswire/ -- SillaJen Biotherapeutics, Inc. (KOSDAQ:215600), a clinical-stage, biotherapeutics company focused on the development of oncolytic immunotherapy products for cancer, today announced that the Independent Data Monitoring Committee (IDMC) for the company’s PHOCUS trial has evaluated the results of a formal pre-planned futility analysis for this study, and has recommended discontinuation of the trial. The PHOCUS trial is a Phase 3 clinical trial evaluating the oncolytic immunotherapy Pexa-Vec (formerly JX-594) for advanced liver cancer. While Pexa-Vec is generally well tolerated by patients, the interim results suggest that the study is unlikely to meet the primary objective by the time of the final analysis. This decision was not related to the safety of the investigational product. SillaJen is taking steps to notify investigators that enrollment is being stopped. SillaJen thanks the patients, caregivers and investigators involved in our clinical study and will continue to seek effective treatments for cancer patients.

“The interim results are a disappointment to the company. However, SillaJen has shifted its focus toward other combination therapies that offer a more compelling and commercially viable solution to address unmet needs in liver cancer as well as other therapeutic areas,” stated Dr. Eun Sang Moon, chief executive officer of SillaJen. “Other programs have continued to deliver encouraging results. The discontinuation of the study will allow us to focus on a more promising development program.”

The PHOCUS trial was designed to enroll 600 patients, worldwide, who had not received prior systemic treatment for their cancer, and they were randomized to one of two treatment groups: one which received Pexa-Vec followed by sorafenib and one which received sorafenib alone. The randomized study was conducted at approximately 86 sites worldwide including North America, Asia, Australia, New Zealand and Europe. The primary objective of the study was to determine the overall survival of patients treated with Pexa-Vec, followed by sorafenib versus sorafenib alone. Secondary objectives included 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.

About Pexa-Vec and the 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 hundreds of millions of people as part of a worldwide vaccination program, and over 480 cancer patients have been treated with Pexa-Vec to date. Pexa-Vec was engineered to target common genetic defects in cancer cells by deleting their thymidine kinase (TK) gene, thus making Pexa-Vec dependent on the cellular TK expressed at persistently high levels in cancer cells. Pexa-Vec is also engineered to express 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. Pexa-Vec has been shown to be effective when delivered both intratumorally and systemically by intravenous administration.

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™ platform. Additional information about SillaJen is available at www.sillajen.com.

SillaJen’s Disclaimer Language:
This press release contains certain forward-looking statements, including but not limited to statements relating to goals, plans, projections of financial position, result of operations, market position, product development and business strategy of the company. Such forward-looking statements are based on current expectations and involve inherent risks, uncertainties, or certain assumptions, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statements shall be guaranteed, and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and SillaJen undertakes no obligation to update any forward-looking statements contained in this release on account of new information or future events, or otherwise, except as required by law.

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SOURCE SillaJen, Inc.