If there was any lingering hope that Vical’s gene therapy might show efficacy in regrowing leg arteries, it has been completely dashed. In trial results that were declared definitive by the lead investigator, Temusi showed itself to be no better than placebo for averting leg amputations and death in patients with critical limb ischaemia (CLI), another blow for a gene therapy space hoping for a big success (AHA Preview – Novel therapies creating excitement at heart conference, November 10, 2010).There was little expectation that the full Tamaris phase III trial data would be more positive than the topline results announced in September (Gene therapy suffers another blow as Temusi crashes out, September 23, 2010). However, in detailing the data at the American Heart Association meeting, lead investigator Dr William Hiatt suggested that gene therapy is unlikely to bear fruit in the angiogenic approach to treating the debilitation condition.
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