CI-1042: Phase II data; Phase III

ONXX published in Cancer Research results of a 37-patient U.S. Phase II trial of CI-1042 monotherapy. Among 24 evaluable patients (who completed at least 2 cycles of therapy), 4 of 19 who received a single daily intratumoral injection of the product for 5 days every 3-week cycle had an objective response, including 2 complete responses and 2 partial responses. Of the other 5 evaluable patients, who received 2 intratumoral injections per day for 10 days twice per cycle, 1 had a partial response and 3 had a minor response. For all 37 patients, the intent-to-treat objective tumor regression rate was 14 percent. ONXX said that the virus replicated in p53-deficient tumor cells but did not replicate in or cause toxicity to normal tissues (p=0.01). ...