Biothera Completes Enrollment of Second Phase 2b Lung Cancer Trial
Published: Mar 13, 2013
EAGAN, Minn.--(BUSINESS WIRE)--Biothera announced today that it has completed enrollment of its 90-patient Phase 2b clinical study of Imprime PGG®, bevacizumab (Avastin®) and two chemotherapeutic drugs in non-small cell lung cancer (NSCLC). Imprime PGG, Biothera’s immunotherapeutic drug candidate, is being evaluated in lung and colorectal cancer, chronic lymphocytic leukemia and non-Hodgkins lymphoma. The open label, randomized Phase 2b study has a dual-arm design and three-week treatment cycles. Treatment in the investigational arm, which enrolled 60 patients, consists of weekly doses of Imprime PGG (4 mg/kg), bevacizumab administered once each cycle, and the chemotherapies carboplatin and paclitaxel administered during week one of the first 4 to 6 cycles. In the control arm, which enrolled 30 patients, treatment consists of the combination of bevacizumab and the chemotherapy regimen (carboplatin and paclitaxel). All patients dose until progression of disease or discontinuation for another reason. The primary endpoint of the trial is overall response rate as assessed by RECIST (Response Evaluation Criteria in Solid Tumors). An Independent Radiological Review Committee will conduct a blinded read of all patient CT scans.