Summary of FDA Trials

In the summer of 2009, MNTR / Quantum Immunologics entered into a consolidated Phase I & II FDA trials to test the patented Oncofetal Antigen (OFA) dendritic cell immunotherapy process with 27 Stage IV breast cancer patients. 

The trials involve treating a sample of the respective patients blood to separate out the dendritic messenger cells.  In a 15 step process, the cells are put in proximity with and sensitized concentrations of OFA.  Portions of the OFA proteins travel to the tips of slender spikes that protrude sea urchin-like from the dendritic blood cells.  When a special white blood cell named a T-lymphocyte bumps into the dendritic cell, the OFA at the spike tip is communicated to the white blood cell.  From then on, when the white blood cell encounters a breast cancer cell that will have OFA on its surface, the cancer is recognized as a pathogen. 

As with any microbe, the sensitized white blood cell then attaches to the cancer cell, excretes hydrogen peroxide to perforate the cell wall and injects granulocytes into the cell to collapse it.

The sensetizing to OFA takes about three days and then 1/3rd of the cells are injected in three inoculations over a two month period.  During treatment, the activated immune system causes the women to have a slight fever and feel like they have the flu.

The above is the intended result and is what is being tested.  The final inoculation is expected at the end of December 2009.  Test results should be ready in march 2010 and published in May 2010.