Biothera Phase II Lung Cancer Trial Fully Enrolled
EAGAN, MN — November 17, 2011 —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.
About Imprime PGG
Imprime PGG® is a novel immunomodulatory drug in development as a cancer therapy. Neutrophils are the most abundant immune cells in the body and normally responsible for pathogen killing, but not anti-tumor activity. In preclinical cancer models, however, Imprime PGG has been shown to bind to neutrophils and harness their killing ability to reduce tumor growth and enhance long-term survival. This targeted mechanism is synergistic with multiple anti-tumor monoclonal antibodies, demonstrating the potential to improve patient outcomes in a wide range of cancer indications. Imprime PGG is currently being evaluated in a Phase III trial in KRAS wild type colorectal cancer and multiple Phase II clinical trials in non-small cell lung cancer and chronic lymphocytic leukemia.
About Biothera, the Immune Health Company
Biothera is a U.S. biotechnology company dedicated to improving immune health. The company is developing pharmaceuticals that engage the innate immune system to fight cancer.
Contact:
David Walsh
VP Communications
Biothera, the Immune Health Company
651-256-4606 (direct)
dwalsh@biothera.com