In the next several days at Duke University MedicalCenter, a comatose hepatitis patient nearing death fromacute liver failure will be hooked up to a transgenic pigliver in what is described as the first Phase I trial forxenotransplantation approved by the FDA.

The transgenic pigs, genetically altered with human genesto prevent rejection of their organs by people, weredeveloped by Princeton, N.J.-based Nextran, which is apartnership between DNX Corp., of Raritan, N.J., andBaxter Healthcare Corp., a subsidiary of BaxterInternational Inc. in Deerfield, Ill.

DNX chairman and CEO, Paul Schmitt, said the trial, inwhich the porcine livers will function ex vivo in place ofthe patient's diseased liver, is the initial step in a two-yearprocess leading to studies involving the actualxenotransplant of transgenic pig livers into humans.

Schmitt said the Phase I trial, conducted in associationwith Duke University in Durham, N.C., is the firstclinical study of the use of transgenic pig organs forhumans.

DNX's stock (NASDAQ:DNXX) rose 38 percentThursday to $4.50, a $1.25 jump. Baxter International(NYSE:BAX) ended the day at $37.62, up $1.

The FDA, which does not regulate human organtransplants, is considering guidelines forxenotransplantation, in part, to minimize risks ofspreading animal viruses to people.

Schmitt said the FDA reviewed and approved the wayNextran produced, raised and controlled the disease statusof its transgenic pigs.

The pigs, which are bred in southeastern Ohio, aregenetically altered with three human genes. Without theproteins expressed by the genes, the patient's complementsystem would quickly reject the pig liver.

In the Duke University study, Schmitt said the aim is toget the transgenic pig organ functioning in place of thefailed liver with the hope of reversing the neurologicalcomplications that caused the patient's coma and ofstabilizing the subject until a human liver transplant canbe performed. If the pig liver works properly, thepatient's own liver also should recover some function.

Ten patients will participate in the trial. Schmitt said theeffects of the transgenic pig livers should be seenimmediately, but data from the studies may not bereported for up to a year. Because the transgenic piglivers are functioning outside the body, as many as 24may have to be used during the course of the patient'streatment.

If the study is successful, Schmitt said the next step willbe to get FDA approval to use the ex vivo pig liversupport system at an earlier stage in the progression of thehepatitis; that is, prior to a patient's liver failure. Afterthat, the clinical trials would proceed to testing actualtransplants of the transgenic pig organs. n

-- Charles Craig

(c) 1997 American Health Consultants. All rights reserved.