Biothera Initiates Phase Ib/IIa Clinical Trial with
Imprime PGG and Erbitux in Metastatic Colorectal Cancer Patients
EAGAN, MN – October 9, 2007 – Biothera announced today that it has initiated enrollment of patients in a phase Ib/IIa clinical trial to evaluate the safety and efficacy of Imprime PGG™ and Erbitux® in patients with metastatic colorectal cancer.
Imprime PGG is a unique biological response modifier that enhances specific innate immune cell responses without inducing pro-inflammatory cytokines. Erbitux (cetuximab) is a monoclonal antibody from ImClone Systems that is approved for treatment of colorectal and head and neck cancer.
Numerous xenograft mouse models have demonstrated that combining Imprime PGG and Erbitux or other anti-tumor monoclonal antibodies, including Avastin® (bevacizumab), and Herceptin® (trastuzumab), significantly reduces tumor size and increases survival compared with antibody therapy alone.
The phase Ib/IIa clinical trial is an open-label, multicenter trial in Asia. The goals of the trial are to assess the safety and efficacy of various Imprime PGG dose levels in metastatic colorectal cancer. The company is planning to follow the study with a double-blind, placebo-controlled Phase IIb trial in a larger patient population.
“This is the first of many trials that combine Imprime PGG and various monoclonal antibodies,” said Daniel K. Conners, Biothera founder and chairman. “Imprime PGG engages an entirely new cancer killing mechanism that complements ADCC and CDC and which may improve the effectiveness of the majority of anti-tumor monoclonal antibodies on the market or in development.”
Imprime PGG has demonstrated a strong safety profile in three clinical trials. Two Phase I clinical trials were conducted under Biothera’s cancer Investigational New Drug (IND) application for the use of Imprime PGG in combination with anti-cancer monoclonal antibodies. Under a separate IND, the company also has completed a Phase I/II trial with Imprime PGG in combination with a hematopoietic growth factor.
About Biothera, the Immune Health Company
Biothera is a biotechnology company dedicated to improving immune health. The company's primary focus is developing pharmaceuticals that engage the innate immune system to fight cancer. Other applications include hematopoietic (white blood cell) recovery and infectious disease.
Contact:
David Walsh
VP, Communications
Biothera, the Immune Health Company
651-256-4606