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who had technical knowledge of coagulation, expertise in leading drug development, and the experience of doing the IPO roadshow for ZymoGenetics back in 2002—then ProFibrix would have somebody who could help it attract more U.S. scientific talent, and get on the radar of U.S.-based investors.
What attracted Öhrström to the new company was ProFibrix’s lead drug candidate, which it calls Fibrocaps. It’s a tissue sealant that is derived from a pair of clotting proteins found in human blood—fibrinogen and thrombin. ProFibrix gathers those proteins from human blood, and spray dries them through a proprietary manufacturing process. That makes them into microparticles in a dry powder, which is stable at room temperature, and just needs a little liquid added (like what is found at a bleeding site) for it to spring into action and start clotting.
This sort of thing could be used by surgeons to control excess bleeding, like the ZymoGenetics drug, and could also be used by paramedics or Army medics who need something quick and convenient to stop bleeding fast, Öhrström says. It would offer a convenient alternative to fibrin sealants made by Baxter Healthcare and Johnson & Johnson, which require thawing or heating, or some kind of mixing or application device, he says.
Convenience is a big part of the story, but Öhrström got more animated talking about the science. Liquid coagulants sometimes have the disadvantage of being applied to a highly viscous bleeding site on the body, and they can run off. When these types of liquid tissue sealants are made into a spray applicator, they also sometimes clog up on the tip and don’t spray very well, Öhrström says.
The ProFibrix microparticles have the physical advantage of being able to embed themselves in any number of difficult situations that doctors and paramedics might face. “When you have a bleeding surface, it’s rarely flat. It’s got crevices,” Ohrstrom says. “A dry powder can conform to any surface.”
OK, so what kind of evidence does ProFibrix have to prove this concept? Not a lot yet. It started enrolling the first of about 20 patients in a clinical trial in June, and hopes to have results in hand by the end of this year. If it can stick to what Öhrström calls “an ambitious timeline,” then it will start a mid-stage trial in 2010 that can roll over into a pivotal study. That trial could form the basis for a new drug application to the FDA by late 2011 or early 2012, he says.
The ProFibrix group in Seattle will likely remain small, Öhrström says. The company has already recruited Linda Zuckerman from ZymoGenetics to head all preclinical development, and it will look to assemble a small team of maybe six to eight people with expertise in drug development, regulatory affairs, and business development. It doesn’t expect to have labs here. “We want to keep the payroll lean,” Öhrström says.
I had to ask Öhrström how he manages in a trans-Atlantic company, with headquarters that operate nine hours ahead of him. Ohrstrom, who is from Denmark, is used to it from his days working with Denmark-based Novo Nordisk before he joined ZymoGenetics. The new job requires that he travel a fair bit to the Netherlands, but he says he doesn’t mind, and it is actually not too much of a strain on his family life.
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