The UK Medicines and Healthcare Products Regulatory Agency has signed off on a Phase 1/2a clinical trial evaluating Transgene’s (OTCPK:TRGNF) TG6002, administered by intrahepatic artery infusion, in colorectal cancer patients with unresectable liver metastases. The single-arm open-label study will assess the safety, pharmacokinetics and efficacy of repeated and ascending doses of TG6002, combined with a prodrug of chemo agent 5-FU, in up to 75 patients. The trial should start next quarter.
The company says TG6002 is a next-generation oncolytic immunotherapy, specifically a modified Vaccinia virus, designed to induce the conversion of the non-cytotoxic prodrug into 5-FU in cancer cells that it has infected, thereby killing the cells.
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