Biothera completes enrollment in Imprime PGG Phase II combination study on NSCLC

Biothera's Phase II non-small cell lung cancer (NSCLC) clinical trial evaluating Imprime PGG® administered in combination with cetuximab (Erbitux®), carboplatin and paclitaxel has met its goal of 90 patients and is fully enrolled, the company announced today.

The open label, multicenter, randomized trial was designed to evaluate the safety and efficacy of Imprime PGG in combination with a monoclonal antibody (cetuximab) and a standard chemotherapy regimen (carboplatin and paclitaxel) compared to cetuximab alone with the same chemotherapy.

"This is an important milestone in developing more effective treatments for NSCLC patients," said Dan Conners, president of Biothera's Pharmaceutical Group. "It is also a significant step forward in Biothera's overall clinical development plan for Imprime PGG."

The primary objective for the study is to determine the anti-tumor effects of Imprime PGG when used in combination with cetuximab and standard chemotherapy, based on overall response rate as assessed by RECIST (Response Evaluation Criteria in Solid Tumors) and evaluated by a blinded independent review committee.