Here are responses from Alan Engbring (Vical IR) re: possible future news events for Vical for the rest of 1999. The responses were received sometime in June/1999.
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The malaria trial with a multiple-gene vaccine candidate is expected to begin late this year, and could, if immunogenicity is sufficient, turn into a challenge trial. We would not want to inflict undue disease or treatment on volunteers if we did not measure an adequate immune response.
You may have seen a recent announcement by Bioject regarding a Phase I trial with our DNA vaccine for malaria. That is simply a repeat of the first Phase I trial with a single-gene vaccine to test the outcome with their device. It seems to have caused some confusion, but is not significant in terms of Vical.
The Merck HIV vaccine project is still at the forefront in their program, and has been elevated in visibility. Merck CEO Ray Gilmartin said nice things about it in a recent Reuters interview, and noted that we should see initial results from a trial within a couple of years. I would hope that means we will see the start of a trial soon, but I cannot make any promises on Merck's behalf.
The Phase II melanoma trial is accruing ahead of schedule, and the Phase III trial is on track for completion as originally planned by mid-year 2000. We have not taken any interim looks at data, but plan to do so late this year or early in 2000, whenever we have enough time with enough patients to make the checkpoint meaningful. It is very expensive to collect and analyze data, so we don't want to do it too often.
Our other possible sources for news in the rest of this year could include a progress report from Dr. Rosenberg on the melanoma vaccine trial (no word on if or when that could happen), new collaborations (always a possibility,never a certainty until they occur), and perhaps an early look at the new head and neck cancer trial at one of the November scientific conferences.
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Bill |
