As I said before it has variety of applications in solid tumors, it’s well tolerated it’s given in a local study. The way it’s given, if you give one injection per week, for six weeks in a row followed by two week of observation period, for a cycle of treatment is eight weeks, okay. And it’s given into tumor release, so you inject the same lesions through the entire therapy, not all the people think by giving it locally that mean some local therapy it’s not a systematic therapy.
I am just flab a guess, if somebody comes and says, well you mean the injected lesion shrinking is how you measure response rate. Well in the RECIST criteria, you measure response rate by identifying a series of up to 10 target lesions and you follow those lesions through the course of the disease in which you base the response rate. Here we’re injecting only one single lesion, we follow all the 10 lesions, so that’s very important thing that everybody needs to recognize.
It has a unique mechanism of action, it drives a systemic effects, it’s a local therapy that drives systemic effect, and I think I am reemphasizing that point, because it’s so important as this therapy it’s completion, coming to a completion of the pivotal trial. It has potential synergy with other therapies, I will talk more about that, it is an Orphan Drug status, it has a Fast Track designation, we have retained U.S. and EU rights and [then the] SPA. So I will talk more about what the design of the studies in a minute.
Well two drugs have been approved for melanoma in the recent times, Yervoy and Zelboraf one is by Roche drug and the other is by Bristol Myers Squibb, those are not cures for melanoma, so there is plenty of room and particularly there’s plenty of room for drug, which can offer a safe efficacious pathway for patients which then exist today, including chemotherapy. Our drugs hopefully if it gets approved and the safety profile bears out, as we have seen in Phase 2 would be a perfect solution for patients.Read the rest of this transcript for free on seekingalpha.com
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