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UK BEGINS CLINICAL RESEARCH TRIAL
FOR NEW PARKINSON'S DISEASE TREATMENT

By Gail Hairston


UK President LeeTodd, left, and researchers Greg Gerhardt and Don Gash announce trial for new Parkinson's disease treatment.

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The system will deliver GDNF directly into the patient's brain. This new therapeutic approach makes possible treatments with drugs that cannot be used at present because they do not cross the blood brain barrier.

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March 18, 2002 (Lexington, Ky.) A team of University of Kentucky College of Medicine researchers has begun a clinical trial of a new investigational treatment for Parkinson's disease that may directly influence the degenerative disease process. Current treatments focus on improving the symptoms of Parkinson's disease patients.

The research team is composed of Greg Gerhardt, Ph.D., professor, Department of Anatomy and Neurobiology and Department of Neurology, director of the Morris K. Udall Parkinson's Disease Research Center of Excellence and director of the Center for Sensor Technology; Don Gash, Ph.D., Alumni Chair in Anatomy and Neurobiology, professor, Department of Anatomy and Neurobiology, and director of the M. Margrite Davis-Ralph E. Mills Magnetic Resonance Imaging and Spectroscopy Center; Byron Young, M.D., Johnston-Wright Endowed Chair of Surgery, professor, Department of Surgery, and chief, Division of Neurosurgery, associate dean for Clinical Affairs, and chief of staff, University of Kentucky Hospital; and principal investigator John Slevin, M.D., professor, Department of Neurology and Department of Pharmacology, and director of the Movement Disorders Clinic at UK.

This is a Phase I clinical research trial, meaning that the researchers are primarily studying the safety of the proposed treatment. Extended studies of the efficacy of the investigational treatment will follow if this early research proves successful.

The foundation for this new investigational treatment came from basic research conducted by Gerhardt and Gash at the Morris K. Udall Parkinson's Disease Research Center of Excellence at UK.

Funded by a $5 million grant from the National Institute of Neurological Disorders and Stroke (NINDS), a division of the National Institutes of Health (NIH), the research concerns glial cell line-derived neurotrophic factor (GDNF) as a possible therapy for Parkinson's disease.

The Morris K. Udall Parkinson's Disease Research Center of Excellence at UK is one of 11 such centers in the United States funded by NIH.

Developed by Amgen Inc., GDNF is a natural growth factor for dopamine neurons and is found in low levels in the adult human brain. It is believed the destruction of these neurons in the mid-brain causes the symptoms of Parkinson's disease; current FDA-approved treatments improve the symptoms but do not alter the underlying disease process. Laboratory studies have demonstrated that GDNF both protects and promotes regeneration of injured midbrain dopamine neurons, and thus may directly influence the degenerative disease process.

This new investigational treatment uses a version of the Medtronic SynchroMedŽ Infusion System, a surgically implantable, programmable pump developed by Medtronic Inc. and pre-clinically tested at UK.

The system will deliver GDNF directly into the patient's brain. This new therapeutic approach makes possible treatments with drugs that cannot be used at present because they do not cross the blood brain barrier.

The battery-powered SyncroMedŽ pump is a round titanium disc, measuring approximately one inch thick and three inches in diameter and weighing 6.5 ounces. Its programmable computer components precisely regulate the flow of a four-week supply of medication directly into the brain by way of an intraparenchymal (IPA) catheter.

The pump currently is approved for delivery of drugs directly to the fluid around the spinal cord in patients with chronic and intractable pain, cancer pain, and severe muscle spasticity, as well as the delivery of chemotherapy agents to treat colorectal cancer that has spread to the liver.

According to the NINDS, Parkinson's disease affects more than 500,000, perhaps as many as one million, Americans; it is estimated that 20,000 Kentuckians have the disease. Parkinson's is a neurological disease, most often of older people, that progressively impairs control of body movement and often leads eventually to rigid immobility.

Symptoms of Parkinson's disease include tremors, stiff limbs, slow or absent movement, lack of facial expressions, a shuffling gait and a distinctive stooped posture. Depression and an impaired ability to think also may develop.

Gerhardt joined the UK College of Medicine in 1999 as part of the Research Challenge Trust Fund (RCTF) set up by the 1997 Kentucky General Assembly to attract researchers to UK. Without the addition of Gerhardt through the RCTF program, UK would not have been competitive for the grant for the Udall Center, which led to this clinical research trial. In addition, this clinical research trial is supported in part through start-up funds for Gerhardt from the RCTF program.

Anyone interested in the research study should call (859) 323-3998.

Those in attendance at the news conference include:

-- Lee T. Todd Jr., Ph.D., president, University of Kentucky;

-- James W. Holsinger Jr., M.D., Ph.D., senior vice president of UK and chancellor, UK Chandler Medical Center;

-- Greg Gerhardt, Ph.D., professor, Department of Anatomy and Neurobiology and Department of Neurology; director, Morris K. Udall Parkinson's Disease Research Center of Excellence at UK; and director, Center for Sensor Technology;

-- Don Gash, Ph.D., Alumni Chair in Anatomy and Neurobiology; professor, Department of Anatomy and Neurobiology; and director of the M. Margrite Davis-Ralph E. Mills Magnetic Resonance Imaging and Spectroscopy Center;

-- Byron Young, M.D., Johnston-Wright Endowed Chair of Surgery; professor, Department of Surgery; chief, Division of Neurosurgery; associate dean for Clinical Affairs; and chief of staff, University of Kentucky Hospital; and

-- John Slevin, M.D., principal investigator, professor, Department of Neurology and Department of Pharmacology, and director of the Movement Disorders Clinic.


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