Intellect Neurosciences Inc. (fka ILNS)

[montanus]

Clinical Trials Update

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



Clinical Trials Update – Sept. 15, 2014

This study is actively enrolling at Emory, U of Iowa, UCLA, and USF.
10-12 subjects are needed to complete the study.
VP20629 – Safety and Pharmacology Study of VP20629 in Adults With FA
Drug: SHP622 (also known as VP20629 or OX1)
Sponsor: Shire (formerly initiated by ViroPharma)
VP20629 (indole-3-propionic acid) is a naturally occurring small molecular weight drug
compound that improves mitochondrial function by preventing oxidative stress.
This is a Phase 1 study designed to evaluate dosage and safety. Four sites are still actively
recruiting for the second arm of the study. In the second arm, subjects will receive multiple
doses of VP 20629 (300 mg, 600 mg, or 900 mg total daily dose) or placebo. VP20629 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 second
arm need to stay in the hospital for 10 days. Any patient who participated in the first arm
(single dose group) is eligible to participate in the second arm (multiple dose group).
Specific information on inclusion and exclusion criteria is available here:
www.clinicaltrials.gov/ct2/show/NCT01898884.
Please call or email one of the sites below if you are interested in participating:
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]
UCLA Medical Center, Los Angeles, CA
Principal Investigator: Dr. Susan Perlman
Coordinator: Brian Clemente, Tel: [phone]; email: [e-mail]
University of South Florida, Tampa, FL
Principal Investigator: Dr. Theresa Zesiewicz
Coordinator: Kevin Allison, Tel: [phone]; email: [e-mail]

www.curefa.org/_pdf/VP20629ClinicalTrialUpdateSep15-2014.pdf