Intellect Neurosciences Inc. (fka ILNS)

[montanus]

Clinical Trials Update – Jan 16, 2014

VP20629 – Safety and Pharmacology Study of VP 20629 in Adults With FA
This study is actively enrolling and looking for volunteers at all sites (UCLA to open soon).
This is a Phase 1 study which means it is designed to evaluate dosage and safety. It is designed in two
arms. The first arm is four groups of 8 individuals (32 individuals needed for the first arm) in which each
individual gets a single dose of the drug and is monitored for 3 days. The first cohort of 8 has been
completed, and they are now enrolling the second cohort of 8 individuals.
After the first arm is completed, there will be a second arm of three groups of 8 subjects (24 individuals
needed for the second arm) in which individuals will receive multiple doses of VP 20629 (300 mg, 600
mg, or 900 mg total daily dose) or placebo. VP 20629 or placebo will be administered every 8 hours for 7
days with a single morning dose on Day 8.
Participation in this study requires both outpatient and inpatient visits. Subjects in the first arm need to
stay at the hospital for 3 days, and subjects in the second arm need to stay for 10 days. Subjects who
participate in arm 1 may be eligible to participate in arm 2.

Specific information on inclusion and exclusion criteria is available at the study’s clinicaltrials.gov site:
www.clinicaltrials.gov/ct2/show/NCT01898884.

Please call or email a coordinator below to get more information about the study.
OPEN FOR ENROLLMENT
Children’s Hospital of Philadelphia, Philadelphia, PA
Principal Investigator: Dr. David Lynch
Coordinators: Lauren Seyer, Tel: [phone]; email: [e-mail] and Debbie Foerster
Tel: [phone]; email: [e-mail]
CHOP study ad - www.curefa.org/_pdf/VP20629ClinicalTrial.pdf
Emory University, Atlanta, GA
Principal Investigator: Dr. George Wilmot
Coordinator: Rebecca McMurray, Tel: [phone]; email: [e-mail]
Emory study ad – www.curefa.org/_pdf/EmoryTrialVP20629.pdf
University of Iowa, Iowa City, IA
Principal Investigator: Dr. Kathy Mathews
Coordinator: Carrie Stephan, Tel: [phone]; email: [e-mail]
University of South Florida, Tampa, FL
Principal Investigator: Dr. Theresa Zesiewicz
Coordinator: Dr. Kelly Sullivan, Tel: [phone]; email: [e-mail]
ENROLLMENT ANTICIPATED SOON
UCLA Medical Center, Los Angeles, CA
Principal Investigator: Dr. Susan Perlman
Coordinator: Brian Clemente, Tel: [phone]; email: [e-mail]

www.curefa.org/_pdf/VP20629-ClinicalTrialUpdate.pdf