Now the company is turning its attention to H1N1. In research that has been fast-tracked by the U.S. Food and Drug Administration, Cel-Sci has created a peptide that it believes will direct the human immune system to fight the virus directly. In collaboration with physicians at Johns Hopkins University’s School of Medicine, researchers are collecting blood from 20 patients hospitalized with H1N1, and 20 healthy controls, then stimulating the blood with their peptide to see if they can initiate the appropriate immune responses.
“We need to find the kinds of responses that have commonly been associated with an ultimate positive outcome,” Kersten says. “If we see those kinds of responses, then, based on FDA discussions, we expect to be able to do a randomized clinical trial.” The group hopes to be able to move forward as soon as their results come in.
Kersten is optimistic. “We have a way, at least in other diseases, of directing the cellular immune response without the production of pro-inflammatory cytokines,” he says, referring to signaling molecules that can incite unwanted inflammation. Cytokines are produced by the body’s own immune cells, but when their production goes unchecked and ramps up too high, they can cause the body to overreact to a virus. Cel-Sci’s approach circumvents such a response.
Cel-Sci creates its peptide using epitopes from the small segments of flu virus that don’t mutate, and which could therefore be used to treat H1N1 even as it changes over the course of the year–such an approach could also be effective against other strains of flu, such as avian (H5N1) and even 1918 pandemic influenza.
Using dendritic cells to direct immune response is an attractive mechanism, says Noel Rose, director of the Center for Autoimmune Disease Research at the Johns Hopkins Bloomberg School of Public Health. “This would have applications far beyond H1N1,” he says. “It would be a nice way of having a person make his own vaccine.”
Rose was not involved in the trial, but his lab will analyze the cytokine results. “I have no idea what to expect, because we don’t know what cytokines are going to be produced.” Even so, he says, “I think it could be really interesting.”