NEW YORK — A phase I clinical trial investigating 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, according to data presented at the Fourth CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference: Translating Science into Survival, held Sept. 30-Oct. 3.
“Even after a single injection of this bacterial therapy, we see biological and, in some patients, clinically meaningful activity,” said Filip Janku, MD, PhD, associate professor at the Department of Investigational Cancer Therapeutics (Phase I Clinical Trial Program), The University of Texas MD Anderson Cancer Center, Houston. “This strategy is feasible, has manageable adverse effects, and could be clinically meaningful in patients with few therapeutic options.”
While prior anticancer therapies have utilized bacteria, these treatments can cause infection and severe side effects, explained Janku. C. novyi-NT is an attenuated bacterium that requires a hypoxic environment, a feature of cancerous lesions, to survive and proliferate and therefore does not affect healthy cells, he noted. “By exploiting the inherent differences between healthy and cancerous tissue, C. novyi-NT represents a very precise anticancer therapeutic that can specifically attack a patient’s cancer,” Janku said.
Janku and colleagues evaluated
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