to tell him the difference between good and mediocre data. He’s a medical doctor himself, who did his residency at Brigham & Women’s Hospital in Boston, and a fellowship in nephrology (the study of kidney function) at Stanford University Medical Center. Brenner spent nine years of his career at Thousand Oaks, CA-based Amgen (NASDAQ: [[ticker:AMGN]]), ending his tenure there in 2008 as executive director of its renal anemia global program. He endured the worst year in the company’s history, 2007, as Amgen was besieged with safety warnings about its anemia drugs for both kidney and cancer patients. After Amgen, he moved up to senior vice president of medical affairs for Lexington, MA-based AMAG Pharmaceuticals, where he was involved in the rollout of that company’s drug for kidney patients, ferumoxytol (Feraheme).
AlloCure, under its new CEO, is now mapping out a course to prove that its therapy really works in a more rigorous mid-stage clinical trial. The company is working on the design of a Phase II trial that will randomly assign patients to get its cell therapy infusion, or something else in a control group. The company is considering different doses and timing for the infusion, to establish whether it can prevent acute kidney injury or help reverse the course of disease once it’s caught in the early stages, Brenner says.
The company has to meet with the FDA to talk about his clinical trial game plan, with hopes of getting the trial going in 2011, Brenner says. AlloCure should have enough money to get the mid-stage trial started, but at some point it will need to consider more financing, from venture capitalists or other sources, he says.
These are, of course, still very early days for AlloCure. Plenty could go wrong in further trials, and the therapy might not work, Brenner says. But if it does, the potential impact for medicine is big. Plenty of companies are testing adult stem cell infusions for various ailments, but no others are pursuing this mode of treatment for acute kidney injury, Brenner says.
“If we can develop a robust treatment, it would be remarkable,” Brenner says. “The benefits to patients and society would be tremendous.”
