Rexahn Pharmaceuticals Submits Serdaxin® Phase II Protocol to FDA for Parkinson’s Disease
News Apr 07, 2010
Rexahn Pharmaceuticals, Inc. has announced that it has submitted a Phase II protocol to the U.S. Food and Drug Administration (FDA) for the clinical study of Serdaxin® for the treatment of Parkinson’s disease (PD).
“We believe that Serdaxin's properties in animal models open exciting possibilities as a new treatment for patients with PD. 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 PD.”
“Serdaxin has demonstrated an ability to prevent neuronal deaths in PD models, and the drug’s positive Phase IIa results in depression further enhance its promise as a treatment for PD,” said Rexahn Chief Executive Officer, Dr. Chang Ahn. “Although there are currently various treatment options for PD, 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 PD and treat the depression so often associated with this disease.”
The Phase II study will assess Serdaxin’s efficacy as a treatment for Parkinson’s disease in approximately 300 subjects. The planned double blind, randomized, 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.
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 PD. 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 PD."