Nearly 800 patients to enroll at over 50 sites worldwide
EAGAN, MN, USA | May 18, 2011 | Biothera began dosing patients today in a Phase III trial evaluating Imprime PGG® in combination with cetuximab (Erbitux®) as a potential new treatment for recurrent or progressive KRAS wild-type colorectal cancer.
The trial design is built on data obtained in the company’s previous clinical studies in colorectal cancer. Biothera has reviewed these results, as well as the protocol for the Phase III study, with the U.S. Food and Drug Administration. The endpoints for the study are designed to include an opportunity for accelerated approval based on interim data.
“Late stage colorectal cancer patients who can neither tolerate nor benefit from chemotherapy represent a large unmet clinical need,” said Dan Conners, president of Biothera’s Pharmaceutical Group. “Based on previous trials, we are confident that the combination of Imprime PGG and cetuximab will prove effective in treating this disease and further extending the survival and quality of life in these patients.”
Study Design
The open-label, randomized study will enroll up to 795 patients and will be conducted in over 50 locations worldwide, including the U.S., Europe and South America.
Patients will be randomized to one of two study arms in a 2:1 ratio. A total of 530 subjects in Arm 1 will receive Imprime PGG and cetuximab and a total of 265 subjects in Arm 2 will receive cetuximab alone. The patients must have received at least two prior chemotherapeutic regiments and cannot have been previously treated with cetuximab or panitumumab.
The primary endpoint for the study is overall survival. Secondary endpoints are progression-free survival, tumor response and quality of life.
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 colorectal cancer and multiple Phase II clinical trials in non-small cell lung cancer and chronic lymphocytic leukemia.
About Biothera, the Immune Health Company
Biothera is a biotechnology company dedicated to improving immune health. The company is developing pharmaceuticals that engage the innate immune system to fight cancer. (www.biothera.com)
SOURCE:Biothera, the Immune Health Company
Post Views: 51
Nearly 800 patients to enroll at over 50 sites worldwide
EAGAN, MN, USA | May 18, 2011 | Biothera began dosing patients today in a Phase III trial evaluating Imprime PGG® in combination with cetuximab (Erbitux®) as a potential new treatment for recurrent or progressive KRAS wild-type colorectal cancer.
The trial design is built on data obtained in the company’s previous clinical studies in colorectal cancer. Biothera has reviewed these results, as well as the protocol for the Phase III study, with the U.S. Food and Drug Administration. The endpoints for the study are designed to include an opportunity for accelerated approval based on interim data.
“Late stage colorectal cancer patients who can neither tolerate nor benefit from chemotherapy represent a large unmet clinical need,” said Dan Conners, president of Biothera’s Pharmaceutical Group. “Based on previous trials, we are confident that the combination of Imprime PGG and cetuximab will prove effective in treating this disease and further extending the survival and quality of life in these patients.”
Study Design
The open-label, randomized study will enroll up to 795 patients and will be conducted in over 50 locations worldwide, including the U.S., Europe and South America.
Patients will be randomized to one of two study arms in a 2:1 ratio. A total of 530 subjects in Arm 1 will receive Imprime PGG and cetuximab and a total of 265 subjects in Arm 2 will receive cetuximab alone. The patients must have received at least two prior chemotherapeutic regiments and cannot have been previously treated with cetuximab or panitumumab.
The primary endpoint for the study is overall survival. Secondary endpoints are progression-free survival, tumor response and quality of life.
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 colorectal cancer and multiple Phase II clinical trials in non-small cell lung cancer and chronic lymphocytic leukemia.
About Biothera, the Immune Health Company
Biothera is a biotechnology company dedicated to improving immune health. The company is developing pharmaceuticals that engage the innate immune system to fight cancer. (www.biothera.com)
SOURCE:Biothera, the Immune Health Company
Post Views: 51
