Replies to post #125683 on Biotech Values

[pcrutch]

I have and I think they're misleading folks. Their Allovectin-7 trial just makes no sense to me and raises a lot of questions. Like why did the FDA give them an SPA for the primary endpoint of durable response rate(DRR) instead of PFS or OS? Why are they comparing it against DTIC/TMZ when TMZ isn't even approved for this indication?

Allovectin-7 has failed previous Phase 3 trials and their response has only been to just keep upping the dosage. Since their first Phase 3 trail, I think they've raised the dosing by a factor of 2000.

http://clinicaltrials.gov/ct2/show/NCT00395070?term=NCT00395070&rank=1

They also try to make a ridiculous comparison of their single-arm Phase 2 study to Yervoy

http://www.vical.com/Theme/Vical/files/doc_downloads/Allovectin%20Efficacy%20and%20Safety.pdf
( Note the asterisk: "*These are a subset of patients from the Phase 2 Vical trial and the Phase 3 DTIC trial with characteristics similar to those enrolling in the Phase 3 trial.")

a free article of their more recent Phase 2 single-arm study

http://clincancerres.aacrjournals.org/content/7/8/2285.full

I smell BS.