I think this article actually helps to confirm Dr Von Hoff's involvement by the natrue of the trial design. It is his design all right and explains also why phase 1 will run 2 concurrent separate trials .. He split off pain and made it just for pancreatic cancer and the other trial tests malignant ascites for all abdominal cancers. I bet he knows what to anticipate in terms of needing validation for the FDA.
"The follow-up study will use the same ES-2 ovarian cancer model. In this study, the mice will be divided into 13 different treatment groups, with 10 mice in each group. The follow-up study is designed to better define the parameters that will be needed to design a future Phase 1 clinical trial in humans that suffer from malignant ascites fluid accumulation as a result of their abdominal cancers, such as pancreatic, liver, ovarian, uterine and colon. The study will be conducted by Translational Drug Development (TD2) in the U.S.which was designed by pancreatic cancer expert Dr. Daniel D. Von Hoff, Chief Development Officer of TD2." February 2015
"Two additional clinical trials will be conducted in the U.S. by Translational Drug Development (TD2). These trials will determine the effectiveness of PharmaCyte Biotech’s treatment in (i) reducing the severe pain that occurs in patients with advanced pancreatic cancer; and (ii) slowing the accumulation of malignant fluid (ascites) that accompanies the development of pancreatic and other solid cancerous tumors in the abdomen." March 2015
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