BRI’s principal research and development efforts currently focus on Antineoplastons (ANPs), which have been investigated in cell culture studies, animal studies, and Phase I and II clinical trials. Recently a new phase II and III studies has been reviewed by the FDA and are awaiting Institutional Review Board (IRB) approval prior to implementation. Further information can be found under the “Research and Development” tab, especially “Antineoplastons”.
The molecular mechanisms underlying the anti-cancer effects continue to be investigated in BRI’s research laboratories. Growth of normal cells is controlled by cell cycle progression genes (oncogenes) and by cell cycle arrest genes (tumor suppressor genes). In cancer, alteration of these control genes in malignant cells favors aggressive cell proliferation. Evidence suggests that the active components of ANP therapy function as “molecular switches” which “turn on” tumor-suppressor genes and “turn off” oncogenes. Preclinical studies have indicated the regulatory properties of ANP therapy in relation to the proliferation pathways of the RAS, AKT2, MYCC and TGFβ1 genes and the tumor-suppressor pathways of the p53, p21, PTEN, INI1 and MAD genes. Hence, the anti-cancer action of ANP therapy may restore cell cycle control, induction of programmed cell death, and interference with cancer cell metabolism and nuclear transport. Literature references to BRI’s current research can be found under the “Research and Development” tab, specifically, “Scientific Publications".