German regulatory authorities have granted approval to Biothera to conduct two open label, multi-centre, randomized phase-II clinical trials studying Imprime PGG administered in combination with monoclonal antibodies and chemotherapy in patients with non-small cell lung cancer (NSCLC), the company announced.

"Our ongoing clinical trial in metastatic colorectal cancer has demonstrated the ability of Imprime PGG to work synergistically with monoclonal antibody therapy, resulting in significant improvements in patient outcomes," said Daniel Conners, Biothera founder and chairman. "We believe that Imprime PGG's unique mechanism of action will result in similar synergies in NSCLC patients."

In the first trial, Imprime PGG will be administered in combination with Avastin (bevacizumab) and two chemotherapeutic agents, carboplatin and paclitaxel. The second trial will study Imprime PGG in combination with Erbitux (cetuximab), carboplatin and paclitaxel. Each trial will enrol up to 90 patients and includes both a treatment arm (consisting of Imprime PGG, a monoclonal antibody and chemotherapy) and a control arm (consisting of the monoclonal antibody and chemotherapy alone).

Imprime PGG is a targeted immunotherapeutic drug candidate that works synergistically with anti-tumour monoclonal antibodies through specific innate immune cell activation.

Biothera is a biotechnology company dedicated to improving immune health. The company is developing pharmaceuticals that engage the innate immune system to fight cancer.