Biothera wins German approval to launch two Phase II lung cancer trials

Biothera, a biotechnology company, has received approval form the German regulatory authorities to conduct two open label, multicenter, randomized Phase II clinical trials studying Imprime PGG administered in combination with monoclonal antibodies and chemotherapy in patients with non-small cell lung cancer.

In the first trial, Imprime PGG will be administered in combination with Avastin and two chemotherapeutic agents, carboplatin and paclitaxel. The second trial will study Imprime PGG in combination with Erbitux, carboplatin and paclitaxel.

Each trial will enroll 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).

The primary objective for each study is to determine the anti-tumor effects of Imprime PGG when used in combination with a monoclonal antibody and chemotherapy, based on overall response rate as assessed by response evaluation criteria in solid tumors.

Daniel Conners, founder and chairman of Biothera, said: 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. We believe that Imprime PGG’s unique mechanism of action will result in similar synergies in non-small cell lung cancer patients.