Vical Inc. (VICL) Bank of America Merrill Lynch Health Care Conference Call May 15, 2012 01:00 pm ET Executives Vijay B. Samant – President and Chief Executive Officer Analysts Rachel Mcminn – Bank of America Merrill Lynch Presentation Rachel Mcminn – Bank of America Merrill Lynch
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So Allovectin-7 something that we’ve been working for very long time, we’re pretty excited the pivotal data from this program will be coming out by the end of this year. It’s a systemic immunotherapy, but the beauty of it, it’s given locally. So the fact that it’s given locally, but works systemically does not have the side effects of traditional systemic drugs.We have treated about 900 patients in variety of cancer applications, its well tolerated. Let me give an example of how it’s given, it’s given in the outpatient setting one injection per week into the lesion and you repeat every week for six weeks in a row followed by two week of observation period. So one cycle of treatment is about eight weeks, in eight weeks you get six injections. Most patients start showing benefit of the drug after about two cycles of treatment, which is 16 weeks or four months. So, the key thing that you need to understand as you walk through my presentation that in immunotherapy the patients need to live long enough to benefit from immunotherapy. It has a unique mechanism of action, I’m not going to spend a lot of time talking about it, you can go to our website and look at it. But, I think the most important thing it has potential synergies with currently approved new therapies for melanoma, it has an orphan drug status or fast-track status. With all the U.S. and EU commercial rights and we have an SP or a Special Protocol assessment with the agency. Our people ask, what’s the melanoma market now that the new two drugs have been approved. There is plenty of room for melanoma. Melanoma is not been cured, the two drugs have benefits, but they have their own toxicity. These kind of patients we’re treating in our Phase 3 trial will represent about third of the vulvar melanoma patients. The current drugs have been priced at $60,000 to $120,000 per therapy, so plenty of room a huge commercial opportunity for a company for our size.
So without getting into how the mechanism works I think the key thing is it’s a unique mechanism and the unique mechanism is such a way that you treat the tumour to teach the immune system to recognize what’s wrong with the cancer and UE use the lesion while you inject Allovectin as a classroom and that classroom is really teaching the immune system. Some immune systems learn very quickly, some immune systems take about 8, 10, 12 months before they learn. And that learning of the immune system is breaking of tolerance or teaching the immune system to recognize what’s wrong with that tumor getting it to recognize the markers that the cancer cell presents on the surface telling the immune system kill me, okay.The most important thing is the newly approved drug therapy, immunotherapy Yervoy which is known as CTLA mAb. In animal studies we’ve shown that we’ve synergy with our therapy, a combination of Allovectin and CTLA mAb actually did better than CTLA mAb alone, so if this translates into human our drug that immunotherapy should have synergistic affects. So Vijay what’s the data. Well Phase 2 trial which we did on 127 patients it’s a single-arm open-label study pretty large for a single-arm open-label study. 50% of the patients where stage 3, 50 % of those patients were stage 4, the key thing is the patients did not have brain mets and liver mets why? Because patients with brain mets and liver mets die very quickly and immunotherapy in order for the patient to benefit, they need to live long enough. What did we accomplish in that study we demonstrated first of all the drug was safe and efficacious, that’s key. Read the rest of this transcript for free on seekingalpha.com