MedicalResearch.com Interview with:
Filip Janku, MD, PhD
Associate Professor, Investigational Cancer Therapeutics
(Phase I Clinical Trials Program)
Center Medical Director, Clinical and Translational Research Center
The University of Texas MD Anderson Cancer Center
Houston, TX 77030
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Clostridium novyi-NT is an attenuated strain of bacteria Clostridium, which induced a microscopically precise, tumor-localized response in a rat brain tumor model and in companion dogs bearing spontaneous cancers. Clostridium novyi-NT can only grow in hypoxic (low-oxygen) tumor environment and destroys cancer cells by secreting lipases, proteases, and other hydrolytic enzymes; recruiting inflammatory cells to tumors eliciting anti-tumor immune responses in animals. Furthermore, intratumoral injection can plausibly induce an immune mediated abscopal effect in non-injected tumor sites.
Therefore, we designed a phase I dose-finding study to test for safety and tolerability of the single intratumoral injection of Clostridium novyi-NT in 24 patients with advanced cancers with no available standard therapies. We also designed experiments to study activation of antitumor immune response in blood and tumor samples from patients undergoing the therapy.
We demonstrated that single dose of intratumoral injection of Clostridium novyi-NT is feasible and has led to significant destruction of injected tumor masses. Adverse events, which were often related to the tumor destruction at the infected site, could have been significant but mostly manageable. Correlative studies of pre-treatment and post-treatment tumor and blood samples suggested immune response to therapy.
MedicalResearch.com: What should readers take away from your report?
Response: Our study demonstrates a novel approach in treatment of cancer using attenuated bacteria, which can grow and destroy cancer in the low-oxygen environment and induce anti-cancer immune response.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: These early signs of anti-tumor activity in patients with advanced cancers have encouraged us to design a new clinical study of Clostridium novyi-NT in combination with an immune checkpoint inhibitor pembrolizumab, which is currently underway.
Disclosures: We received funding through participating institutions from Biomed Valley Discoveries to conduct this study. I would like to thank study teams at MD Anderson Cancer Center, Memorial Sloan Kettering Cancer Center, Washington University St. Louis and Cleveland Clinic for their help with patients’ enrollment; the team at Mayo Clinic for performing correlative studies and the study team at Biomed Valley Discoveries for supporting and funding this study.
First-in-man clinical trial of intratumoral injection of Clostridium novyi-NT spores in patients with treatment-refractory advanced solid tumors: Safety, activity, and immune responses
Filip Janku, MD, PhD, The University of Texas MD Anderson Cancer Center, will present Abstract A011, “First-in-man clinical trial of intratumoral injection of Clostridium novyi-NT spores in patients with treatment-refractory advanced solid tumors: safety, activity, and immune responses,” during Poster Session A on Sunday, Sept. 30. This trial demonstrated that the use of bacterial Clostridium novyi-NT spores as an injectable monotherapy had manageable toxicities and showed early clinical efficacy in patients with treatment-refractory solid tumor malignancies.
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