Imprime PGG® Improves Survival in KRAS Mutant
Colorectal Cancer Patients
Data to be presented at European Society for Medical Oncology (ESMO)
13th World Congress on Gastrointestinal Cancer
BARCELONA, SPAIN — June 22, 2011 — Biothera will present data from its Phase II clinical trial in stage IV KRAS mutant colorectal cancer at the European Society for Medical Oncology (ESMO) 13th World Congress on Gastrointestinal Cancer June 22-25.
In a heavily pretreated subject population that is known not to respond to cetuximab (Erbitux®), Biothera’s Imprime PGG® has provided important improvements in key patient outcomes compared to historical data based on the mean of three published studies for Erbitux alone.
• A 40% increase in median survival to 28 weeks.
• A 115% increase in one-year survival. Five of 18 subjects (28%) survived at least one year while two subjects are still alive ~2 years after enrollment.
• An objective response (tumor burden decrease of >30%) in one subject.
• An approximately 75% improvement in disease control to 39%.
• A well-tolerated safety profile.
“These data represent compelling clinical proof of concept support for the potential of Imprime PGG to provide significant clinical benefits to this unserved patient population,” said Daniel Conners, Biothera Pharmaceutical Group president. “We are currently evaluating next steps in the continued clinical development for this indication.”
Biothera’s ESMO presentation abstract is entitled, “Imprime PGG Plus Cetuximab Therapy for Advanced KRAS Mutant Colorectal Cancer.”
Biothera is conducting multiple clinical trials in various cancers to evaluate the therapeutic efficacy of its developmental drug Imprime PGG, which induces a neutrophil killing mechanism normally used against antibody-targeted pathogens, and redirects this mechanism against antibody-targeted tumor cells.
Previous clinical research has suggested synergistic efficacy in subjects with KRAS wild type colorectal cancer when Imprime PGG is added to a regimen containing cetuximab. Although tumor cells in subjects with KRAS mutant colorectal cancer express the receptor for cetuximab and bind the antibody, in these cells, cetuximab does not inhibit the signals that promote tumor cell proliferation due to constitutive signal transduction induced by the KRAS mutation. Since Imprime PGG-activated neutrophils will still recognize cetuximab-targeted cancer cells, researchers hypothesized that this therapeutic regimen would also be effective against mutant KRAS colorectal 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 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. For more information, visit http://www.biothera.com/pharmaceutical/pipeline.html.
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