Biothera Initiates Phase Ib/IIa Clinical Trial with Imprime PGG and Erbitux in Metastatic Colorectal Cancer Patients.EAGAN, Minn. -- 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 PGG Purple, Green, and Gold (Mardi Gras beads colors) PGG Project Galactic Guide PGG Patrol Gunboat (Missile) PGG Pendleton Grain Growers, Inc. (Pendleton, OR, USA) [TM] and Erbitux[R] in patients with metastatic colorectal cancer. Imprime PGG is a unique biological response modifier biological response modifier n. A substance, such as interferon, that is produced naturally or manufactured as a drug designed to strengthen, direct, or restore the body's immune response against infection or cancer. 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 xenograft /xeno·graft/ (zen´o-graft) a graft of tissue transplanted between animals of different species; it may be concordant, mouse models have demonstrated that combining Imprime PGG and Erbitux or other anti-tumor monoclonal antibodies, including Avastin([R]) (bevacizumab), and Herceptin([R]) (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 ADCC antibody-dependent cell-mediated cytotoxicity. ADCC antibody-dependent cell-mediated cytotoxicity. and CDC See Control Data, century date change and Back Orifice. CDC - Control Data Corporation 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 hematopoietic /he·ma·to·poi·et·ic/ (-poi-et´ik) 1. pertaining to hematopoiesis. 2. an agent that promotes hematopoiesis. hematopoietic 1. pertaining to or affecting the formation of blood cells. 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
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