Dr. Michael Har-Noy, founder and CEO of Immunovative Therapies Ltd., a biotech company in Israel, has invented a unique compound, AlloStim™, which stimulates a patient’s own immune system to attack cancer cells. This enables a patient’s own immune system to potentially scavenge and eliminate every metastatic cell. AlloStim™ is produced from T-Stim cells, which are manufactured at Immunovative Therapies through proprietary, patented methods.

Dr. Michael Har-Noy describes T-Stim cells as being produced outside the body in a nine-day proprietary culture process (patents pending) in a bioreactor. T-Stim cells are produced from CD4+ CD45RA+ naïve T-cell precursors that are isolated from the blood of normal donors. Characteristically, 100 million of these cells can be made from one normal person’s blood. After the nine-day culture process, approximately ten billion T-Stim cells can be manufactured. There is no need to match donor to recipient as is necessary in bone marrow transplant procedures – AlloStim™ is intentionally mis-matched to the patient receiving it.

To manufacture T-Stim cells, Dr. Michael Har-Noy says that the naïve CD4 cells are cultured on a matrix coated with monoclonal antibodies. These monoclonal antibodies, namely anti-CD3 and anti-CD28, together with the cell-to-cell contact due to the high cellular density in the culture, causes activation, growth and maturation of the CD4 cells. The cells multiply at least 100-fold over the culture period, resulting in one normal donor producing enough T-Stim cells for about 100 patients.

At Immunovative Therapies, in this controlled environment, the T-Stim cells mature into memory CD4 cells that produce extremely high amounts of IL-2, IFN-g and TNF-a when activated. Also, T-Stim cells express high density CD40L and FasL on their cellular surface. CD40L interacts with the CD40 expressed on innate immune cells and stimulates these cells to manufacture Th1 cytokines that kill malignant cells. FasL enables these cells to kill tumors.

Dr. Michael Har-Noy adds that in order to produce the Mirror EffectTM, the name Immunovative Therapies has given to this unique method of immune system manipulation, the T-Stim cells require activation prior to infusion into the patient. T-Stim cells are activated with monoclonal antibody-coated particles that are then removed before infusion. “AlloStim™” is the name given to activated, formulated T-Stim cells.

Dr. Michael Har-Noy indicates that Immunovative Therapies is preparing to test AlloStim™in a Phase II/III double-blind randomized trial of pre-treated metastatic breast cancer patients.