Introgen Therapeutics Inc announced that final data from a phase 1 trial of INGN 241 in patients with solid tumours were presented at the 7th Annual Meeting of the American Society of Gene Therapy, which was held in Minneapolis.
The data show that direct injection of INGN 241 into tumours activated programmed cell death pathways, stimulated the immune system and reduced the levels of proteins associated with cell migration and tumour metastasis. Clinical activity was observed in two of five patients that received repeat injections of INGN 241, including a patient with metastatic melanoma who had a complete response in two separately injected tumours. The study also showed that INGN 241 was well tolerated, with the most common side effects consisting of transient low-grade fever and mild pain and swelling at the injection site.
"These clinical data are consistent with the very promising results of multiple preclinical studies, and suggest that INGN 241 may have significant potential in the treatment of cancer," said Robert E. Sobol, Introgen's senior vice president, Medical and Scientific Affairs. "In addition to confirming previously observed alterations in the expression patterns of several key cancer-related genes, these clinical data also suggest that direct injection of INGN 241 into tumours may stimulate the immune system to attack cancer cells and was well-tolerated by the patients who received INGN 241," he added.
In the phase 1 trial, INGN 241 was administered by direct intratumoral injection to patients who subsequently had their tumors surgically removed. The first five cohorts received a single injection of INGN 241, with the dose increasing for each cohort, and then underwent surgery 24 to 96 hours post- dosing. The last two cohorts had tumor biopsies performed pre-treatment and 30 days post treatment, with the final cohort receiving twice-weekly injections of INGN 241 for three weeks.