The Phase II study enrolled seven patients with locally advanced rectal cancer. TNFerade was administered weekly to patients via intratumoral injections during the first five weeks of radiotherapy. All patients also received oral capecitabine twice daily during radiotherapy. Surgical removal of the tumor occurred 6-9 weeks after therapy. The treatment was both feasible and appeared to be well tolerated, GenVec said.
Prior to treatment, four of the seven patients were classified as highly likely to need sphincter removing surgery with colostomy. Subsequent to TNFerade plus chemoradiation, all seven patients who underwent surgical resection had successful sphincter sparing procedures. Five of the seven patients achieved pathological complete response.
Mark Thornton, GenVec’s senior vice president of product development, said: “We are pleased to see these encouraging early results with TNFerade in rectal cancer. The data suggest that the study should continue, and we look forward to seeing additional data from this proof-of-concept trial.”