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Parkinson's drug, Serdaxin, in phase II study

Rexahn Pharmaceuticals has submitted a phase II protocol to the US FDA for the clinical study of Serdaxin for the treatment of Parkinson's disease

Rexahn Pharmaceuticals has submitted a phase II protocol to the US Food and Drug Administration (FDA) for the clinical study of Serdaxin for the treatment of Parkinson's disease. The planned double-blind, randomised, placebo-controlled trial will include the Unified Parkinson's Disease Rating Scale (UPDRS) and quality-of-life instruments as study endpoints and will be conducted at multiple sites and involve 300 patients.

"Serdaxin has demonstrated an ability to prevent neuronal deaths in Parkinson's disease models, and the drug's positive phase IIa results in depression further enhance its promise as a treatment for Parkinson's disease," said Rexahn's chief executive officer, Dr Chang Ahn.

"Although there are currently various treatment options for Parkinson's disease, a meaningful cure is overdue. Based on Serdaxin's novel action as a dual serotonin and dopamine enhancer, we believe it has the potential to be the first drug of its kind to target both the classic symptoms of Parkinson's disease and treat the depression so often associated with this disease."

Rexahn is a clinical stage pharmaceutical company commercialising potential best in class oncology and central nervous system therapeutics.

Rexahn also has formed a Parkinson's Scientific Advisory Board (SAB) composed of leading medical researchers in the field of neurology, who will advise on the design and development of the Serdaxin clinical trials.

Commenting on the protocol submission, Dr William Weiner, chairman of the SAB, and head of the Maryland Parkinson's Disease and Movement Disorders Center, and professor and chair of the Department of Neurology at the University of Maryland School of Medicine, said: "We believe that Serdaxin's properties in animal models open exciting possibilities as a new treatment for patients with Parkinson's disease. All the members of the SAB will be actively engaged in Serdaxin's clinical development, which we hope will further establish the drug's efficacy in treating Parkinson's disease."

7th April 2010

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