Dr. Michael Har-Noy, founder and CEO of Immunovative Therapies, Ltd., a biotechnology company in Israel, indicates that malignant tumors often work to suppress immunity by creating an imbalance in type 1 T-helper (Th1)/type 2 T-helper (Th2) cell ratios. Th1 cells tend to promote cellular immunity while Th2 cells suppress a patient’s immune response. Cancer patients generally have decreased numbers of Th1 cells and thus are unable to respond with effective immunity.

Dr. Michael Har-Noy says that this Th1/Th2 imbalance is in part caused by active actions of tumor cells resulting in production of cytokines, which promote Th2 immune responses while simultaneously suppressing Th1 immune actions. Dr. Michael Har-Noy goes on to say that the purpose of the priming phase of his Chaperone Rich Cell Lysate (CRCL)-AlloVaxTM protocol is to re-engineer the patient’s immune response into one where Th1 cells, rather than Th2 cells are the dominant responders. This alteration will 'prime' the patient’s immune system to respond more effectively when exposed to tumor antigens in the subsequent phases of the study protocol. Dr. Michael Har-Noy adds that cellular immunity is generally considered the most effective type of immunity against malignancies.

Dr. Michael Har-Noy says that in order to modulate the Th1/Th2 balance of immune cells, the unique vaccine-like properties of Immunovative Therapies, Ltd.’s experimental drug AlloStim™ are utilized. All vaccines require an antigen and an adjuvant. Dr. Michael Har-Noy indicates that AlloStim™ is really a self-contained vaccine because it consists, in part, of an antigen component and an adjuvant component. The compound AlloStim™ contains living immune cells that are activated with monoclonal antibody-coated microbeads. AlloStim™ is synthesized from the blood of normal donors who are unrelated to the study patient. The AlloStimTM cells are therefore completely foreign to the patient's immune system.

Dr. Michael Har-Noy says that the foreign proteins on the AlloStim™ cells act as powerful antigens. When the AlloStim™ cells are activated by the microbeads, they produce pro-inflammatory cytokines (such as tumor necrosis factor-alpha, interferon-gamma, and granulocyte-macrophage colony stimulating factor) which are understood to powerfully augment a patient’s Th1 immune response. Therefore, says Dr. Michael Har-Noy, injection of AlloStim™ can vaccinate a patient against foreign antigens and can produce an increase in Th1 cells specific for the foreign antigens in the patient’s circulation. This, in turn, can rectify the faulty immune response caused by the lack of Th1 cells in the cancer patient’s circulation.