Thursday, November 27, 2014 12:26:24 AM
Besides one or two tumor types from Phase 1, I think retinoblastoma is also in the planning.
“Given the limited treatment options, devastating effects, and small patient population, Cellceutix believes that retinoblastoma would make an excellent candidate for a phase 2/3 trial once our present phase 1 trial is completed. It would qualify for a number of FDA programs (Orphan, Fast Track and Breakthrough) that can exponentially shrink development time, should clinical data support the current research.”
http://cellceutix.com/cellceutix-plans-for-future-trials-aimed-at-the-latest-initiatives-of-breakthrough-designation-by-the-food-and-drug-administration/#sthash.s8sjSh7g.dpbs
Q. Will you begin your clinical trials with a Phase 1 or combination Phase 1/2?
“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.”
http://cellceutix.com/cellceutix-confident-as-cancer-compound-shows-activity-in-all-cancers-tested/#sthash.EMeizFX2.dpbs
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