European Union specified OvaRex (Mab) as a rare disease drug for the treatment of ovarian cancer

One novel approach, now in Phase III trials at more than 60 research centers across the United States, is OvaRex MAb, a murine monoclonal antibody, a type of biotech drug derived from mouse cells. It is being tested by highly regarded United Therapeutics, based in Silver Springs, Maryland. Their lead drug Remodulin, an injection which treats pulmonary arterial hypertension, is currently being marketed all over the world. More than $32 million has been spent on researching and the development of OvaRex, and it is available on the market by 2008.

OvaRex was developed in Canada by a company called ViRexx Medical Corp, and first tested in that country. According to Dr. Lorne Tyrrell, Chief Executive of ViRexx, his whole study has been set up with the FDA. This is a study where the drug has been given fast track approval and orphan drug status. Dr. Tyrrell is also a Professor of Medical Microbiology and Immunology at the University of Alberta, and Director of the National Centre of Excellence for Viral Hepatitis Research.

OvaRex was tested in Canada, prior to the current Phase III trials in America have been a number of patients that have suffered from OvaRex and turned out to have no adverse effects from these patients. After being injected intravenously, OvaRex binds to an antigen circulating in the blood. An antibody general purpose is to neutralize an antigen. After an OvaRex injection, the murine monoclonal antibody binds to the CA-125 antigen.

In a way the body is tricked. But, the body is tricked in order to help ave itself from the harmful antigen. When the OvaRex antibody is bound to the CA-125 antigen, the new combination is identified as a harmful unit. Before then, the antigen wanders through the body, without alerting the body defense systems, the dendritic cells, to attack and destroy the harmful antigen. Because the body is trained to identify and zero in on a foreign protein, in this case a mouse protein, it alerts the dendritic cells. Until then, the dendritic cells tolerate the cancerous cells. The tolerance is what permits the cancer to spread throughout the body. OvaRex seeks to break the tolerance. The murine monoclonal antibody is designed to target and bind exclusively to free floating CA-125 antigen.

The dendritic cells refuse to tolerate the foreign protein. When the antibody binds with the free-floating antigen, the dendritic cells recognize the complex (antibody plus antigen) as being foreign and engulf the new unit. The dendritic cells break down the key proteins of this unit, presenting all parts on the cells surface. At the point, the body killer T-Cells is alerted to fight the internal threat to the body. Once activated, the T-Cells will replicate and create more killer T-Cells. Any tumor cells expressing the CA-125 antigen is targeted for destruction. The army of T-Cells moves to attack the ovarian cancer tumor.

More can be found here: http://www.cusabio.com/Polyclonal-Antibody/HIST1H2AG--Antibody-11106201.html