University of Kentucky awarded $6 million for GDNF and relate...( UK's research into GDNF made headline...)

UK's research into GDNF made headlines recently when the CBS news show "60 Minutes" broadcast a feature on the controversy that arose when Kentucky and New York patients enrolled in a national Phase 1 clinical trial for the drug were left without medical treatment or legal recourse when Amgen, Inc., the biotech firm that holds the patent for GDNF, suddenly withdrew the drug from testing amidst allegations of safety and efficacy concerns.

Amgen's own bioethicist told CBS that the decision was largely a result of a nervous pharmaceutical industry haunted by the specter of the Vioxx lawsuits. CBS also uncovered video footage in which an Amgen executive stated that the treatment in its current incarnation, a complex procedure involving deep brain surgery, would not be a money maker for the corporation. Shortly after halting the trial and withdrawing all GDNF treatment from patients, Amgen applied for a new patent on a different form of GDNF that could potentially be delivered in a more economical capsule form.

Despite the requests of investigators, the pleas of patients and the approval of the Food and Drug Administration, Amgen has refused to provide the drug under compassionate use guidelines to those patients who had undergone surgery to implant a pump and catheter in their brains, and had been receiving GDNF successfully for as long as two years. Court cases in Kentucky and New York have been dismissed and appeals are being considered.

While distinctly troubled by the plight of patients caught in the crossfire of the first GDNF trials, Gerhardt says Parkinson's researchers are far from giving up all hope in GDNF. He continues to work with the drug in animal models, and to explore similar molecules to which Amgen does not possess patent rights. By exploring multiple paths of research at once, Gerhardt and his colleagues are applying the old maxim "don't put all your eggs in one basket," to the newest science imaginable.

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Contact: Allison Elliott
allison.elliott@uky.edu
859-257-1754
University of Kentucky
12-Sep-2005

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