EAGAN, Minn.--()--Biothera announced today that it has completed enrollment of its 90-patient Phase 2b clinical study of Imprime PGG®, bevacizumab (Avastin®) and two chemotherapeutic drugs in non-small cell lung cancer (NSCLC). Imprime PGG, Biothera’s immunotherapeutic drug candidate, is being evaluated in lung and colorectal cancer, chronic lymphocytic leukemia and non-Hodgkins lymphoma.
“Completing enrollment in our second randomized and controlled Phase 2b clinical trial in non-small cell lung cancer is an important milestone in the development of Imprime PGG”
The open label, randomized Phase 2b study has a dual-arm design and three-week treatment cycles. Treatment in the investigational arm, which enrolled 60 patients, consists of weekly doses of Imprime PGG (4 mg/kg), bevacizumab administered once each cycle, and the chemotherapies carboplatin and paclitaxel administered during week one of the first 4 to 6 cycles. In the control arm, which enrolled 30 patients, treatment consists of the combination of bevacizumab and the chemotherapy regimen (carboplatin and paclitaxel). All patients dose until progression of disease or discontinuation for another reason. The primary endpoint of the trial is overall response rate as assessed by RECIST (Response Evaluation Criteria in Solid Tumors). An Independent Radiological Review Committee will conduct a blinded read of all patient CT scans.
“Completing enrollment in our second randomized and controlled Phase 2b clinical trial in non-small cell lung cancer is an important milestone in the development of Imprime PGG,” said Dan Conners, president of Biothera’s Pharmaceutical Group. “The interim trial data has exceeded our expectations and we are excited about the potential of Imprime PGG to become a valuable treatment option for NSCLC patients.”
Biothera completed enrollment of its first randomized and controlled Phase 2b clinical trial in NSCLC in 2011. That trial had the same protocol design as the second study, but used the monoclonal antibody cetuximab (Erbitux®). The preliminary study results have been positive and the Company anticipates that final data will be released in the very near future.
Lung cancer claims more lives than any other cancer, with more than 1.3 million deaths annually. In the U.S., lung cancer is the leading cause of cancer death for both men and women and claims more lives than colon, breast, and prostate cancers combined. Non-small cell lung cancer is the most common type of lung cancer.
About Imprime PGG
Imprime PGG is a novel immunomodulatory drug in development as a cancer therapy. Neutrophils are the most abundant immune cell 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 redirect 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 2-3 trial in KRAS wild type colorectal cancer and multiple Phase 2 clinical trials in non-small cell lung cancer and chronic lymphocytic leukemia. A study in non-Hodgkins Lymphoma will commence in the coming months. For more information, view the Biothera drug pipeline.
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.