Biothera receives approval to launch two lung cancer trials

Mar 12 2009

German regulatory authorities have granted approval to Biothera 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 (NSCLC), the company announced today.

“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.”

Study Designs

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 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 RECIST (Response Evaluation Criteria in Solid Tumors).

About Non-Small Cell Lung Cancer (NSCLC)

Cancer is a leading cause of death worldwide. Lung cancer claims more lives than any other cancer, with more than 1.3 million deaths annually. In the U.S., lung is the leading cause of cancer death for both men and women and claims more lives than colon, breast, and prostate cancers combined. The National Cancer Institute estimates that there were more than 215,000 new cases of lung cancer last year in the United States. Approximately 75 percent of all diagnosed lung cancers are due to NSCLC.

About Imprime PGG

Imprime PGG is a targeted immunotherapeutic drug candidate that works synergistically with anti-tumor monoclonal antibodies through specific innate immune cell activation. Imprime PGG activates a large population of the body's immune cells (neutrophils) to kill cancer cells. Unlike other drugs that trigger a broad innate immune response, Imprime PGG selectively activates immune cells without inducing systemic pro-inflammatory cytokines, which reduces potential side effects. As a platform therapeutic in oncology, Imprime PGG has the potential to improve patient response rates for existing monoclonal antibody therapies in approved indications, create new indications for these drugs and enhance the efficacy of development-stage monoclonal antibody drugs.