Clinical Trial Shows Effective, Low-Toxic Bacteria in Patients With Solid Tumors: One Study – Xinhua

WASHINGTON, Sept. 30 (Xinhua) – A clinical trial showed that the use of bacterial spores had early efficacy and manageable toxicity in patients with malignant tumors of solid tumors refractory to treatment.

"Even after a single injection of this bacterial therapy, we are observing biological activity and, in some patients, clinically significant," said Filip Janku, associate professor at the MD Anderson Cancer Center at the University of Texas.

Janku announced the results Sunday at the CRI-CIMT-EATI-AACR International Conference on Cancer Immunotherapy, which ran from September 30 to October 3.

"This strategy is feasible, has manageable side effects and could be clinically significant in patients with few therapeutic options," said Janku.

Unlike previous anticancer treatments that may cause infection and serious side effects, C. novyi-NT is an attenuated bacterium requiring an oxygen-poor environment to survive and proliferate and, therefore, not affecting the cells. healthy.

"By exploiting the inherent differences between healthy tissue and cancerous tissue, C. novyi-NT represents a very precise cancer treatment that can specifically address the cancer of the patient," said Janku.

The Janku team injected the spores into the tumor during the Phase I clinical study in 24 patients with solid tumors refractory to treatment. Of these, 15 had sarcoma, seven had various carcinomas, and two had melanoma.

A single dose was administered between 10,000 and 3 million spores and it was found that the maximum tolerated dose was 1 million spores.

According to the study, the shrinkage of the tumor by more than 10% was observed in 23% of patients. In addition, tumors of 46% of them showed spore germination and resultant lysis of the tumor cells.

"Despite the absence of clinical signs of germination in some patients, we found an improvement in tumor-specific immune response through increased secretion of T-cell cytokines and the increased presence of tumor-infiltrating lymphocytes in injected tumors, "said Janku.

"Based on these preliminary results, it appears that C. novyi-NT is able to activate the immune response in addition to causing the destruction of the tumor," said Janku.

The limitations of this study include a short follow – up time for some patients, as many of them have already participated in other clinical trials where they were available.