A Phase II efficacy trial enrolling 100 to 200 wound patients would cost about $9 million—and if the therapy being tested included only a few types of phages, as the first trial did, there's a good chance it wouldn't pan out for patients whose infections are caused by multiple strains of bacteria. And given the current regulations, Vazzana isn't sure he could even find the capital to fund the trial.
But phage researchers like Ben Burrowes of the Texas Tech University Health Sciences Center are optimistic. "Companies will start coming out with phage products at some point," he says, "and once those first few get through the approval process, the FDA will relax its standards a little."
Rockefeller University biologist Vincent Fischetti, for one, isn't holding his breath. Fischetti has no doubt that there's a gaping hole in the health-care landscape where effective antibacterial drugs should be. He just isn't sure phages are the best way to fill the void. To him, Wolcott and his fellow phage-therapy practitioners are like peacekeepers with no governmental backing: well-intentioned, to be sure, but unlikely to have much success in the end. "I'm not working on phage therapy," he insists, as he guides me through his sixth-floor lab overlooking the institute's Manhattan campus. "I'm working on phage-based therapy."
So he is taking an alternative approach, purifying the phage to extract the lysin, the enzyme it uses to dissolve the bacterial cell wall and kill the bacterium. He enlists his lab staff to serve as biological prospectors, collecting the bacteria-killing viruses from swamps, rivers, anywhere they can find them. He points to a bag of smelly bat excrement on his windowsill. "We can take the phages out of that stuff."single page
Five amazing, clean technologies that will set us free, in this month's energy-focused issue. Also: how to build a better bomb detector, the robotic toys that are raising your children, a human catapult, the world's smallest arcade, and much more.