Wolcott met Intralytix CEO John Vazzana at a phage conference in Texas three months after he returned from Europe. The two talked for hours about the frustrating plight of phages in the U.S. By the end of the conference, they had hatched a plan to convince the FDA to let them start a clinical trial. Intralytix would supply the phages; Wolcott, the patients.
Every week, Wolcott's study participants arrived at the clinic and received their phages through a handheld ultrasonic device, a high-tech upgrade to the IV drips common in Eastern Europe. The device simultaneously sprays on saline-based phage solution and destroys blackened or dead tissue, allowing the phages to penetrate deeper into the wound. Like all initial clinical trials, Wolcott's was designed to assess the safety of the therapy, not its outright effectiveness. In this context, the study yielded promising signs for the future. None of the patients in the trial reported severe side effects, but the efficacy was unimpressive. Nearly 70 percent of the volunteers experienced significant healing by the end of the 24-week trial period, as did a similar percentage of trial patients who did not receive the phage. Wolcott anticipated this, and attributes it to the fact that the cocktail was not tailored to combat the particular bacteria in his patients' wounds, as is standard practice in Georgia, limiting the phages' potency.
And this is where Wolcott hits a wall. FDA regulators have told him that if he wants to use phages on his patients, he's going to have to carry out a separate clinical trial for each phage or particular mix of phages he hopes to administer, just as he would if he were shepherding distinct chemical compounds through the regulatory process. But since each of his patients' wounds might contain hundreds of different species of bacteria, he can't reasonably attempt to conduct trials of the thousands of phage combinations required to combat them all, especially considering that the cost of a trial for a single drug can easily run into the millions. "People in this country have a right to be incensed that we have a very different situation here than in Europe with regards to phage," says Betty Kutter, a phage researcher at Evergreen State College. "Our whole regulatory environment has been one major thing that has slowed people down."
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.