Innovation Pharmaceuticals Inc (IPIX)

[sox040713]

The planned Phase 2/3 trials are Leo’s way to telling us that efficacy was observed without actually saying it. Since Phase 2/3 is an expedited pathway, you need pretty darn strong clinical evidences to get approval from the FDA. If nothing is observed in Phase 1, why waste tens of millions of dollars on Phase 2/3? That money could be used for the different trials of B and other defensin mimetics. Just like B, those who got the hint from Leo will get a really nice ROI.

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