Leo on Kevetrin Phase 1 strategy:

A lot of thought has gone into this strategy. Early on, before we realized the potential of our compound across so many cancers, we were planning a Phase 1/2 targeting cancers of the head and neck. However, as we started seeing results against drug-resistant cancers, we realized that we had a drug far better than we could have ever dreamed. Thereafter, we learned of its p53 activity which became a game changer. The strategy then became to begin with a Phase 1 against solid tumors. Continuing with this strategy, and subject to FDA approvals, we plan that at the conclusion of the Phase 1 to choose a cancer for fast track with a Phase 2/3 application. In addition, the strategy would be to select another cancer which would qualify as an orphan drug for Phase 2/3 studies. We believe this is the right strategy based on pre-clinical studies showing the range of Kevetrin’s “p53? mechanism of action.