Tampa, FL (Dec. 2, 2014) — The University of South Florida (USF) Morsani College of Medicine is conducting a clinical research study on erectile dysfunction (ED) in patients suffering from Parkinson’s disease. The principal investigator for the study is Dr. Theresa Zesiewicz, a medical doctor, professor of neurology and the director of clinical research for the USF Frances Zesiewicz Parkinson’s Research Foundation.
The new pilot study will test the safety and effectiveness of an investigational combination medication for ED in patients with Parkinson’s disease who fail to respond to current standard ED medications. Enrollment begins this month.
While Parkinson’s disease is a movement disorder, the non-movement symptoms, including ED can present challenges to the normal activities of life. ED is more common in men with Parkinson’s disease, with a reported prevalence rate of approximately 60 percent. The current standard of care is oral treatment with phosphodiesterase-5 inhibitor (PDE-5i) medications, such as Cialis®, Viagra®, or Levitra®; however, a large percentage of these patients fail to respond adequately to this treatment.
Dr. Theresa Zesiewicz
“Clearly, this is a patient population in need of improved treatments,” said Dr. Zesiewicz. “The non-motor symptoms of Parkinson’s disease are often more bothersome and hinder quality of life to a greater degree than the motor symptoms of the disease, including tremor and rigidity. It’s important that we continue to identify non-motor symptoms in our patients and develop new strategies to treat them.”
In the current clinical study, Dr. Zesiewicz will treat volunteer, Parkinson’s disease patients who have ED with a combination medication designed to help those who respond poorly to PDE-5i medications, such as Cialis®, Viagra®, or Levitra®. All qualifying study participants will receive the active medications. Participant progress and the effectiveness of the medication will be monitored and assessed in comparison to baseline values. Sagene Pharmaceuticals Inc., of Oldsmar, FL, which holds the intellectual property for the combination medication, is helping to fund this study. The pilot study is designed to help determine the value of this product as a potentially new treatment for ED in the Parkinson’s population.
The USF Parkinson’s Disease Foundation and Clinical Research Center treats approximately 2,500 patients per year from the Tampa Bay region and surrounding areas. Located in the Carol & Frank Morsani Center for Advanced Healthcare on the USF Tampa campus, the center focuses on clinical care and new therapies for motor and non-motor symptoms of Parkinson’s disease. Dr. Zesiewicz and nurse practitioners Tracy Jones, ARNP, and Terry McClain, ARNP, provide state-of-the-art care to patients with Parkinson’s disease.
For more information, please call 813-974-5909 and ask to speak to Tanya Aranca or Kevin Allison.
About Sagene Pharmaceuticals
Sagene Pharmaceuticals is a biopharmaceutical company developing novel applications for combinations of FDA-approved drugs to treat ED. Sagene has shown that its patented combinations can enhance efficacy of current ED treatments by targeting multiple disease pathways not typically addressed by approved drugs. The combination approach for treating diseases with FDA-approved drugs to improve their therapeutic effect, reduces development risk, time and costs by utilizing the 505(b)(2) NDA approval process. Sagene has assembled a team of experts experienced in drug development, clinical trials and regulatory affairs. Sagene has conducted preclinical studies showing proof of concept and the benefits of combination therapy in laboratory animals and human platelets. Sagene is seeking funding partners to develop its ED combination in areas of unmet need such as Parkinson’s disease and diabetes. The company is headquartered in Oldsmar, FL.
For more information about Sagene Pharmaceuticals, please visit the Company’s website at www.sagenepharma.com.
About USF Health USF Health’s mission is to envision and implement the future of health. It is the partnership of the USF Health Morsani College of Medicine, the College of Nursing, the College of Public Health, the College of Pharmacy, the School of Biomedical Sciences and the School of Physical Therapy and Rehabilitation Sciences; and the USF Physician’s Group. The University of South Florida is a Top 50 research university in total research expenditures among both public and private institutions nationwide, according to the National Science Foundation. For more information, visit www.health.usf.edu
Media contact:
Anne DeLotto Baier, USF Health Communications
abaier@health.usf.edu or (813) 974-3303
