Re GNVC Au contraire: from the 10Q:
Based on the results of our Phase I studies, we initiated a Phase II dose-escalation study in 50 patients with locally-advanced, inoperable pancreatic cancer to determine the best therapeutic dose for use of TNFerade in combination with standard chemoradiation. Results from this study suggested a dose-dependent improvement in tumor response, rates of surgical resection, time to disease progression, and survival. Based on these data, we initiated a randomized, controlled Phase II study of 74 patients. In consultation with the FDA, this Phase II study was amended in March 2006 to become a pivotal Phase II/III 330-patient trial (PACT) that would support registration of TNFerade for this indication. The primary endpoint for the PACT trial is survival at 12-months. We conducted an interim safety and efficacy analyses of the Phase II/III trial in the fourth quarter of 2006, and in December 2006, we reported the preliminary analysis of safety data based on the first 40 patients treated, and on overall survival data, a secondary endpoint, on the first 51 patients treated. Additional data was presented at the annual meeting of the American Society for Clinical Oncology in June 2007 at which we reported an increase in overall survival from 11.1 months for patients receiving standard of care alone versus 19.3 months for patients receiving TNFerade plus standard of care. ...."
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