ADVENTRX Announces Negative Results From Trial Of ANX-510
ADVENTRX Pharmaceuticals announced results from its Phase 2b clinical trial of ANX-510, or CoFactor, for the treatment of metastatic colorectal cancer.
The CoFactor/5-FU (5-fluorouracil) arm demonstrated comparable overall safety to the leucovorin/5-FU arm. However, the CoFactor/5-FU arm did not demonstrate statistically significant improved safety in the trial's primary endpoint, a reduction in the proportion of patients reporting at least one hematological or gastrointestinal adverse event of grade 3 or greater.
In addition, no statistically significant differences between the arms were observed across overall safety and efficacy variables.
"The results of this trial are disappointing in that we were unable to demonstrate better safety with CoFactor plus 5-FU versus leucovorin plus 5-FU in the infusional setting," stated Evan M. Levine, chief executive of ADVENTRX. "We will carefully analyze the full set of data and our assumptions underlying the development of CoFactor for the treatment of metastatic colorectal cancer in determining the future of this program."
"Beyond CoFactor, we remain focused on completing our marketing-enabling clinical trial of ANX-530, our vinorelbine emulsion product candidate, and initiating a marketing-enabling clinical trial of ANX-514, our docetaxel emulsion product candidate," Mr. Levine continued. "We expect to announce the results for ANX-530 later this year and, if positive, to submit an NDA next year. Our financial position, with approximately $38 million in cash, cash equivalents and short-term investments, remains strong."
One hundred fifty patients were randomized to each arm. Currently, of the patients randomized to the CoFactor/5-FU arm, 70 remain alive and, of the patients randomized to the leucovorin/5-FU arm, 65 remain alive.
This international, open-label, randomized, controlled Phase 2b clinical trial was designed to evaluate the safety and efficacy of CoFactor/5-FU compared to leucovorin/5-FU for the treatment of first line metastatic colorectal cancer. Three hundred patients were randomized to receive CoFactor/5-FU or leucovorin/5- FU. The primary endpoint was a reduction in the proportion of patients with at least one grade 3 or greater toxicity assessment in the category of "Blood/Bone Marrow" or "Gastrointestinal" adverse events (as defined by the NCI Common Terminology Criteria for Adverse Events, version 3). Superiority of the CoFactor/5-FU arm versus the leucovorin/5-FU arm was to be demonstrated by a two-sided p<0.05 calculated by Fisher's exact test performed on the safety population. James Cassidy, MD, MBChB, MSc, FRCP, Professor of Oncology and Head of the Department of Cancer Research in the U.K. Department of Medical Oncology at the University of Glasgow in Glasgow, Scotland, was the study chair.