Current Operations
BRI’s principal research and development efforts currently focus on ANP. The anticancer activity of these compounds has been documented in preclinical studies employing the methods of cell culture, pharmacology, cell biology, molecular biology, experimental therapeutics and animal models of cancer. At the level of Phase II clinical studies, BRI believes the anticancer activity of ANP is supported by preliminary results from ongoing, FDA-authorized, Phase II clinical trials.
The cellular mechanism underlying the anticancer effects of ANP continues to be investigated in both BRI’s own basic preclinical research program and in independent laboratories around the world. A review of this work suggests several mechanisms that may underlie the antineoplastic activity of ANP. For example, it has been found, in cell culture experiments, that ANP induce pathologically undifferentiated cancer cells to assume a more normal state of differentiation. Cell culture experiments have also shown that ANP components can kill some cancer cells by activating the cell’s intrinsic suicide program. It must be noted that data collected in cell culture experiments may or may not indicate the mechanism of action of ANP in humans.
At a more molecular or sub-cellular level, cell culture experiments have shown that ANP can block biochemical pathways involving oncogenes required to produce abnormal cell growth. In addition, cell culture experiments have shown that ANP can increase the expression of anticancer tumor suppressor genes. Although these experiments were conducted using human cancer cells, they may or may not indicate the mechanism of ANP action in humans.
In addition to the original family of ANP compounds (parent generation), BRI continues its development of a second generation of ANP. In cell culture experiments, the second generation ANPs, which were developed by BRI, have been proven to be significantly more potent than the parent generation.
BRI is also developing a third generation of structurally-altered ANP that BRI believes will exhibit markedly improved anticancer activity in human cancer cell lines that have been resistant to the parental generation. However, increased ANP activity in cell culture experiments may or may not translate into increased efficacy in humans.
BRI is also involved in ongoing studies examining the pharmacokinetics (absorption, distribution, metabolism, and excretion) and pharmacodynamics (dose-response) of ANP in patients with neoplastic disease.
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