TCON - TRACON Pharma says amended protocol for ENVASARC trial approved at all 30 clinical sites

TRACON Pharmaceuticals (NASDAQ:TCON) on Tuesday said the amended protocol to its ENVASARC trial as approved by the U.S. Food and Drug Administration (FDA) in February has been accepted at all 30 clinical sites of the trial in the U.S. and UK. TCON's ENVASARC trial is evaluating antibody envafolimab and envafolimab in combination with Bristol Myers Squibb's (BMY) Yervoy for the treatment of soft tissue sarcoma cancers undifferentiated pleomorphic sarcoma and myxofibrosarcoma. In February, the FDA approved the amended ENVASARC protocol following a recommendation by an independent committee. The protocol was amended to double the dose of envafolimab to 600 mg from 300 mg every three weeks. “We are pleased to have opened every site under the amended ENVASARC protocol that increases the envafolimab dose to 600 mg within two months of FDA approval in February,” said TCON CEO Charles Theuer. “We look forward to the interim ENVASARC safety and efficacy data

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TRACON Pharma says amended protocol for ENVASARC trial approved at all 30 clinical sites