Published Bavituximab results quite impressive overall. For those deeply involved in the treatment of aggressive cancers which have metastasized and failed primary treatment, the results of 2nd line treatment with Bavituximab are actually quite good, and point to the future use of Bavi before the cancer and its treatment reach such an advanced stage The chances of these favorable results occurring by chance are roughly the same as getting hit by a live round in a game of Russian roulette. Because of the impressive safety profile amassed over the years in lower animal and now human trial, as well as evidence of anti-tumor activity, it appears that Bavituximab will progress along the clinical trials pathway, and in the future will probably accrue several additions and modifications because of the impressive framework on which it is constructed. Over the past 10-15 years immune therapy has become a standard treatment for a variety of cancers. Monoclonal antibodies and immune adjuvants such as cytokines, interleukins, interferons, thalidomide, and BCG, and vaccines against oncogenic viruses are now well-established cancer therapies. Immune modulation is an important element of supportive care for several high-dose chemotherapy regimens, and immune activation is a central mechanism of bone marrow transplantation for blood cell malignancies. Advances in understanding of interaction between tumors and the immune system have led to new investigational treatments, and continue to drive efforts to find more potent therapies. PPHM’s Bavituximab is a novel approach to immune-based cancer treatment. Originally conceived of as a “double armed” monoclonal antibody capable of attaching to a unique docking site on cancer blood vessels with one arm, and carrying a cancercidal agent in the other, unarmed or naked “Bavi” (by itself) was also found to exhibit antitumor immune responses in the host by expanding tumor-reactive “anti-proliferative” T cells, and thereby antagonizing regulatory pathways that induce immune tolerance. Most accept that the future of cancer therapy will include immune therapy, and is likely to combine more than one of these immunomodulatory approaches to generate more effective treatments. For the time being “naked” Bavi appears to have therapeutic usefulness, and should be sped forward through regulatory channels to make it available to cancer patients. The spin-offs from anti-phospholipid related discoveries should keep PPHM at the forefront of cancer treatment for some time.
