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BiotechTracker: MDX-010 Begins Phase II Breast Cancer Trial 
SSeptember 08, 2003 Medarex (NASDAQ: MEDX) initiated a 33-patient, open-label, phase II clinical trial of MDX-010 for patients with metastatic breast cancer. Participants will receive monthly MDX-010 3.0 mg/kg for up to four cycles. Tumor and immune responses will be the primary analytical foci. The drug, an anti-CTLA4 antibody, is currently in multiple phase II clinical trials in various cancer indications as well as a phase I clinical trial designed to explore its feasibility in the management of human immunodeficiency virus (HIV) infection. 

Thus far, MDX-010 has generated mixed results in particularly fascinating phase II metastatic melanoma studies. Half of the constructs’ recipients experiencing autoimmune adversities also experienced an anti-tumor response. Conversely, no patient experienced an anti-tumor response without experiencing autoimmune adversity. Thus, modification of the anti-tumor immune response appears intimately associated with modification of normal immune function, at least without further refinement of the protocol. 

Development of MDX-010 will accelerate understanding of the role of CTLA-4 in modulating the immune response to tumors. Results so far have (1) demonstrated a role for CTLA-4 blockade in cancer immunotherapy, (2) established a clinically important role for CTLA-4 in the maintenance of tolerance against self antigens in humans, and (3) begged for continued study of MDX-010 alone and in combination with tumor vaccines. Future study is likely to elucidate the relationship between autoimmune effects against normal tissues and against tumors, which will lead to better understanding of clinically relevant means to dissociate normal from anti-tumor immune response.     
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