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     253  0 Kommentare Transgene Provides an Update after the Interim Futility Analysis of the PHOCUS Study of Pexa-Vec in Liver Cancer - Seite 2

    A conference call in English is scheduled on August 7, 2019, at 6:30 p.m. CET (12:30 pm EST).

    Webcast link to English language conference call:
    https://channel.royalcast.com/webcast/transgene/20190805_1/

    Participant telephone numbers:

    France: +33 (0) 1 7037 7166

    United Kingdom: +44 20 3003 2666

    United States: +1 202 204 1514

    Confirmation code: Transgene

    A replay of the call will be available on the Transgene website (www.transgene.fr) following the live event.

    -Ends-

    About the PHOCUS trial
    The PHOCUS trial was a Phase 3 clinical trial evaluating the oncolytic immunotherapy Pexa-Vec for advanced liver cancer patients who have not received prior systemic treatment for their cancer. The study was conducted by Transgene’s partner, SillaJen.
    In the PHOCUS study, patients were randomized to one of two treatment groups: one receiving Pexa-Vec followed by sorafenib and one receiving sorafenib alone. 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
    Pexa-Vec (formerly JX-594/TG6006 - pexastimogene devacirepvec) is an oncolytic immunotherapeutic based on an oncolytic vaccinia virus armed with a GM-CSF gene that promotes an anti-tumor immune response. Pexa-Vec is designed to selectively target and destroy cancer cells through three different mechanisms of action: selectively destroy cancer cells through the direct lysis (breakdown) of cancer cells through viral replication, reduce the blood supply to tumors through vascular disruption, and stimulate the body’s immune response against cancer cells.
    In a Phase 2 study, results of patients with advanced liver cancer showed that patients receiving the high dose had a statistically significant clinical improvement in terms of overall survival compared to the group receiving the low dose. Median overall survival was respectively 14.1 months in the high-dose group and 6.7 months in the low-dose group, which compares favorably with current approved treatments. (Heo J. et al., Nature Medicine, March 2013, doi: 10.1038/nm.3089)

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    Transgene Provides an Update after the Interim Futility Analysis of the PHOCUS Study of Pexa-Vec in Liver Cancer - Seite 2 Regulatory News: Transgene (Paris:TNG), a biotech company designing and developing virus-based immunotherapies for the treatment of solid tumors, provides an update on the interim futility analysis of the PHOCUS study of Pexa-Vec in liver cancer. …