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March 14, 2014
08:26 EDTPPHMPeregrine updates progress in IST Phase I/II trial of bavituximab with sorafenib
Peregrine Pharmaceuticals announced the presentation of an update to the ongoing Investigator-Sponsored Trial, or IST, of its immunotherapy bavituximab in combination with the chemotherapy sorafenib in patients with advanced hepatocellular carcinoma, or HCC, or liver cancer. In a presentation titled: "Combination of Bavituximab and Sorafenib Inhibits HCC Growth: Results of Preclinical Data and a Phase I Study" Dr. Adam Yopp, Assistant Professor of Surgery at the University of Texas Southwestern Medical Center, Dallas, Texas provided an overview of the preclinical data and the ongoing Phase I/II trial. "The Phase II portion of this trial is ongoing with 34 of the 38 intended patients currently enrolled, 10 of which are currently on treatment with the longest one on treatment for 18 months," said Dr. Yopp. "This open-labeled trial is almost complete and while the results are preliminary, they are promising. I am excited about this potential combination given the new understandings about bavituximab's mechanism and I look forward to sharing the full set of data from this Phase II trial later this year." The Phase II portion of this trial is a single-center, single-arm, non-randomized, open-label trial with the primary endpoint of radiologic time to progression with imaging occurring at 6 week intervals. Secondary endpoints of the trial include overall survival, progression free survival, safety and response rates. The trial is scheduled to enroll 38 patients with advanced liver cancer. In addition, in order to leverage recent understandings surrounding the immune-stimulatory mechanism of action of bavituximab, several additional components have been installed into this portion of the trial. These include plasma and serum collection and tissue biopsies for evaluating changes in immune response following bavituximab treatment. Specifically, to assess whether combination therapy reactivates tumor immunity by changing the tumor microenvironment from immunosuppressive to immunoreactive, changing the tumor infiltrating cell composition or inducing T cell response to tumor antigens.
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