Transgene: First Patient enrolled in Phase I Trial of TG4023 for the Treatment of Liver Tumours
Transgene S.A. announced the enrolment of the first patient in the Phase I trial of TG4023 (MVA-FCU1), its newest product to enter clinical trials. Transgene is developing TG4023, a Modified Vaccinia Ankara (MVA) based product, as a targeted chemotherapy treatment for patients with primary or secondary hepatic tumours mainly related to metastatic colorectal cancer (mCRC) or hepatocellular carcinoma (HCC). TG4023 has a unique mechanism of action that converts a non-cytotoxic pro-drug, 5-FC, into 5-FU, a classic chemotherapeutic agent.
Transgene’s Phase I trial will take place in six centres in France and should enrol 20 patients. The primary endpoints are to assess the safety and maximum tolerated dose of TG4023. Eligible patients will have at least one unresectable tumour in the liver and no other option for treatment or care. Each patient will receive one percutaneous injection into the hepatic tumour followed by the administration of 5-FC. Several dose levels of TG4023 will be administered in successive cohorts in order to define the maximum tolerated dose. Transgene expects to report preliminary safety data in the third quarter of 2010, with complete data planned by the first quarter of 2011.
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