Halle Zhang, PhD, of BioMed Valley Discoveries gave an invited talk at the National Cancer Institute (NCI) Conference on Microbial-Based Cancer Therapy in Bethesda, MD. Abstract:Clostridium novyi-NT (C. novyi-NT) is an attenuated strain of Clostridium novyi, an obligate anaerobe that germinates in hypoxic tumor environments. When administered intravenously or intra-tumorally, C. novyi-NT spores replicate within the hypoxic regions of tumors, eliciting robust tumor lysis in a variety of preclinical animal models as well as in companion dogs bearing spontaneous solid tumors. C. novyi-NT lyses malignant cells by secreting lipases, proteases, other hydrolytic enzymes, and recruiting inflammatory cells to elicit an anti-tumor immune response. In the ongoing 3+3 dose escalation, human Phase 1 study, evidence of C. novyi-NT germination including fever, elevated WBC, elevated C-reactive protein, tumor inflammation and abscessation has been noted at all six dose levels following a single intra-tumoral injection. Efficacy and safety data will be reported for the 23 patients enrolled to date. The current dose escalation study is near completion. Potential additional clinical trials are being considered.