Theralase CEO Roger White talks to Cantech Letter What are your chances of getting Fast Track approval from the FDA? What about Breakthrough Status?
Fast Track and Breakthrough Status are defined by the FDA as “a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions (such as cancer) and fill an unmet medical need (no therapy exists or by providing a therapy which may be potentially better than available therapy).” Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition (cancer) and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s). (Phase 1/2a clinical data). Based on these definitions, Theralase has a 99% chance of achieving Fast Track Status and after completion of a successful Phase 1/2a clinical trial over a 90% chance of achieving Breakthrough Status.
We are completing our preclinical work at Princess Margaret Cancer Centre and plan to use Princess Margaret as the lead Canadian site for the Phase 1/2a clinical trial.
Have you tested your four key compounds you developed over last 10 years in other cancers. If so, what were the results?
We have completed testing our four lead PDCs on a variety of cancers, such as brain, breast, colon, prostate, pancreatic and lung, in addition to bladder cancer, both in in-vitro models (Petri dish of cells) and small animal in-vivo models all with up to 100% cancer kill and virtually 0% toxicity.