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It's good news that the University of Kentucky Udall Center received this funding. They will be able to continue animal studies of GDNF. But this funding does not address the plight of the human subjects, who had been helped by GDNF for over 2 years, until the treatments were stopped by Amgen. The researchers at the U of K who were involved in the Phase I human GDNF trial are all dedicated doctors who went out on a limb to try to get Amgen (the patent holder of GDNF) to reinstate the trial participants' treatments under the FDA's compassionate use provisions. Amgen refused.

Linda

-- "Nina P. Brown" <[log in to unmask]> wrote:
LEXINGTON, Ky. -- A University of Kentucky research center has received $6 million to study a
controversial drug treatment for Parkinson's disease.

The funding came from the National Institutes of Health and the National Institute of Neurological
Disorders and Stroke for study of the drug GDNF (glial cell line-derived neurotrophic factor). The
university's Morris K. Udall Parkinson's Disease Research Center of Excellence will conduct the
research.

The drug was pulled from a University of Kentucky study last year. The drug's producer, Amgen, said
studies found that high doses caused brain damage in some monkeys.

The university said in a statement Tuesday that GDNF has demonstrated the potential to halt and in
some cases reverse Parkinson's, a brain disorder that causes tremors and stiffness in the body.

The director of the Udall Center, Greg Gerhardt, said the center will conduct a five-year study of
the drug, including its potential negative effects and how to fine-tune dosing to improve
effectiveness.

Eight Parkinson's disease patients had filed a lawsuit in Kentucky to force Amgen to provide the
drug in a clinical trial, but a federal judge in Lexington sided with the company. U. S. District
Judge Joseph Hood ruled in July that the company had demonstrated that the drug wasn't effective and
had safety concerns. A similar lawsuit was filed in New York in April, but it was dismissed.

Gerhardt said the drug, a synthetic protein, still holds promise.

"History is riddled with examples of technology that failed more than once before being perfected,"
he said in a statement. "The Wright brothers crashed a few airplanes. GDNF has not failed so
spectacularly, although we still have much to learn about it."

Gerhardt is also exploring molecules similar to GDNF that Amgen, based in Thousand Oaks, Calif., has
not patented.

Officials with Amgen have said they decided to stop the GDNF trials after a thorough review of
clinical and safety data.

Copyright 2005 Associated Press. All rights reserved. This material may not be published, broadcast,

rewritten, or redistributed.

Nina P. Brown
"Circumstances determine our lives,
 but we shape our lives by what we make of our circumstances."
Treasurer and Founding Board Member, Texans for Advancement of Medical Research (www.txamr.org)
State Coordinator, Parkinson's Action Network (www.parkinsonaction.org)
Vice President Houston Area Parkinson Society (www.hapsonline.org)



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