US-based Biothera has finished enrolling 90 patients in a Phase IIb trial of immunotherapeutic drug candidate Imprime PGG, bevacizumab (Avastin) and two chemotherapeutic drugs in non-small cell lung cancer (NSCLC).
The open-label, randomised study is designed with an investigational arm and a control arm, and treatment cycles of three weeks.
Biothera pharmaceutical group president Dan Conners said the enrolment completion marks a vital milestone in Imprime PGG's development.
"The interim trial data has exceeded our expectations and we are excited about the potential of Imprime PGG to become a valuable treatment option for NSCLC patients," Conners said.
A total of 60 patents were enrolled in the investigational arm, which consists of weekly doses of Imprime PGG (4mg/kg), bevacizumab administered once each cycle, and the chemotherapies carboplatin and paclitaxel administered during week one of the first four-to-six cycles.
The study enrolled 30 patients in the control arm with the combination of bevacizumab and the chemotherapy regimen (carboplatin and paclitaxel) treatment.
An overall response rate, as assessed by response evaluation criteria in solid tumours, is the trial's primary endpoint.
A blinded read of all patient's CT scans will be performed by an independent radiological review committee.
Biothera is assessing Imprime PGG in lung and colorectal cancer, chronic lymphocytic leukaemia and non-Hodgkins lymphoma.
Photo: Biothera completed enrolment in second Phase IIb trial in non-small cell lung cancer. Image: Courtesy of Biothera.