Neuren Pharmaceuticals is pleased to announce their third site participating in their Phase II, Open Label, PWS Study (Neu-2591-PWS-001) is now open for screening!
Important information regarding this exciting milestone:
- Three sites are now open to enrollment! Rare Disease Research (RDR), located in Atlanta, GA, and Uncommon Cures, located in Chevy Chase, MD (8 miles outside of Washington, D.C.) and Suburban Research in Philadelphia are now welcoming children with PWS and their families to their clinic for screening into this trial.
- The duration of active treatment in this study is 13 weeks. In a preclinical study in animals, physiological and behavioral symptoms were normalized within six weeks of dosing.
- Enrollment currently continues in children diagnosed with PWS who are in the older age group (ages 8 through 12).
- After safety and tolerability data in the older group is independently reviewed (which will commence following the treatment of 3 patients in the older age group), it will be announced when children in the younger group (ages 4 through 7) can start to be screened.
- As this is an open-label study, all children who participate on this trial will receive the study drug (NNZ-2591).
- All travel and lodging for in-clinic visits (5 in total) can be fully reimbursed for patients and their families.
- If NNZ-2591 development moves into Phase 3, all children who participate in this Phase II study may be eligible for an Open-label Extension study that would be opened in parallel to the NNZ-2591 Phase 3 trial in PWS.
- For more information on how to enroll, please contact Henry Nickson at PWStrialreferral@precisionformedicine.com or call 470-883-2822.
Jennifer Bolander has been serving as a Special Education Specialist for PWSA (USA) since October of 2015. She is a graduate of John Carroll University and lives in Ohio with her husband Brad and daughters Kate (17), and Sophia (13) who was born with PWS.
Perry A. Zirkel has written more than 1,500 publications on various aspects of school law, with an emphasis on legal issues in special education. He writes a regular column for NAESP’s Principal magazine and NASP’s Communiqué newsletter, and he did so previously for Phi Delta Kappan and Teaching Exceptional Children.
Evan has worked with the Prader-Willi Syndrome Association (USA) since 2007 primarily as a Crisis Intervention and Family Support Counselor. Evans works with parents and schools to foster strong collaborative relationships and appropriate educational environments for students with PWS.
Dr. Amy McTighe is the PWS Program Manager and Inpatient Teacher at the Center for Prader-Willi Syndrome at the Children’s Institute of Pittsburgh. She graduated from Duquesne University receiving her Bachelor’s and Master’s degree in Education with a focus on elementary education, special education, and language arts.
Staci Zimmerman works for Prader-Willi Syndrome Association of Colorado as an Individualized Education Program (IEP) consultant. Staci collaborates with the PWS multi-disciplinary clinic at the Children’s Hospital in Denver supporting families and school districts around the United States with their child’s Individual Educational Plan.
Founded in 2001, SDLC is a non-profit legal services organization dedicated to protecting and advancing the legal rights of people with disabilities throughout the South. It partners with the Southern Poverty Law Center, Protection and Advocacy (P&A) programs, Legal Services Corporations (LSC) and disability organizations on major, systemic disability rights issues involving the Individuals with Disabilities Education Act (IDEA), Americans with Disabilities Act (ADA), and the federal Medicaid Act. Recently in November 2014, Jim retired.