Innovation Pharmaceuticals Inc (IPIX)

[sox040713]

Leo’s original plan was to run a Phase 1b/2 trial in combination with doxorubicin, which you were overjoyed by the 1b part remember? If I’m Leo and want to ‘drag’ it out for as long as possible, I would’ve run the Phase 1b/2 trial.

The safety and PK/PD data of K Phase 1 and Phase 2a can be referenced so oral K doesn’t have to start all over again.

Why want to know the exact MOA? I think it’s to take advantage of FDA’s new initiative to approve a drug based on a biomarker. For K it could be p53/p21. If K is approved for ovarian cancer, it could be approved for any solid tumor without running additional trials.

FDA approves first cancer treatment for any solid tumor with a specific genetic feature

“The U.S. Food and Drug Administration today granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker). This is the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated.”

https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm560167.htm