The first question is what is the efficacy potential of Allovectin. Let me remind you that in our Phase II trial we focused on two efficacy endpoints, response rate and survival. We had 15 responders out of 127 patients for an overall response rate of about 12%. The median duration of response was 13.8 months. Overall survival in our Phase II trial was 18.8 months compared to a typical chemotherapy survival range of 6 to 11 months.

So our numbers look good in Phase II, but let me explain why we expect our results in Phase III to be even better. First, we wanted to select patients in our Phase III trial who had the best chance of living long enough for Allovectin-7 to work. Chemotherapy takes a toll on overall health and especially in the immune system, so chemo-naïve patients have a healthier constitution. In our Phase II trial, the majority of our responders were chemo-naïve. In fact, patients who were chemo-naïve had a response rate almost twice the rate as patients who had prior chemotherapy. So Allovectin simply works better in chemo-naïve patients. We have, therefore, enrolled only chemo-naïve patients in Phase III.

We have also enrolled healthier patients with no brain or liver mets and normal LDH, which should help us. To our knowledge, we are the first company to use LDH as a marker for recruitment in a melanoma trial. In addition, we measured LDH at our central lab to eliminate side-to-side variability in testing. For patients in our Phase II trial who met all the Phase III eligibility criteria, the response rate could have been about 17%.

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