Lorus cancer trial progressing after review

An independent data safety monitoring board (DSMB) reported that the company’s ongoing phase III registration clinical trial in advanced pancreatic cancer, for its lead anticancer drug Virulizin, can continue without modification to the study design.

The DSMB arrived at its independent conclusion after reviewing preliminary trial data. The principal objective of the review was to evaluate the interim safety of the study.

Additionally, Lorus reported that the results of the pharmacokinetic (PK) drug interaction portion of the phase III clinical trial revealed no significant adverse interactions between Virulizin and the current standard of care in pancreatic cancer, gemcitabine (Eli Lilly’s Gemzar).

“The favorable safety profile of Virulizin, along with the positive outcome of the PK portion of our ongoing phase III clinical trial is very important as we prepare for the conclusion, data analysis and planned new drug application (NDA) for this important registration study in pancreatic cancer,” said Lorus’ CEO Dr Jim Wright.

Virulizin is a novel immunotherapy that stimulates a patient’s innate immune system through the activation of macrophages and the infiltration of NK cells into tumors. Evidence of clinical response was observed in phase II clinical studies of Virulizin as a monotherapy in advanced pancreatic cancer. Median survival in these phase II studies compared favorably with single-agent chemotherapy trials, and in contrast to most standard chemotherapeutic drugs, Virulizin was well tolerated.