FDA Investigational New Drug Application Documents for Cyclodextrin Treatment for Niemann Pick Type C Disease
September 13, 2009 by Chris Hempel
Filed under FDA Cyclodextrin Filings
Here you will find detailed documents outlining Addi and Cassi’s cyclodextrin infusion treatments. We filed a compassionate use IND application to the US FDA in early 2009 to give intravenous cyclodextrin treatment which was approved. In September 2010, FDA approved a new request to put HPBCD directly into the brains of the twins. Addi and Cassi’s treatment is currently being managed by Dr. Caroline Hastings and Children’s Hospital Oakland and is also monitored by the FDA.
Addi and Cassi’s Intratehcal Cyclodextrin FDA Filings
FDA Filing Requesting To Put Cyclodextrin Into The Brains of the Addi and Cassi – August 2010
Addi and Cassi’s Cyclodextrin Infusion Treatments Submitted to FDA – First Protocol Extension
Dr. Caroline Hastings Submission Letter to FDA – May 2009
Cyclodextrin Protocol Extension Letter To Dr. Ruyi He, Acting Director of FDA
Addi and Cassi Hempel FDA Cyclodextrin IND Extension
Cyclodextrin Specimen Collection Document
Addi and Cassi Hempel BioSampling Protocol
Addi and Cassi’s Compassionate Use IND Documents Submitted To FDA For Cyclodextrin Treatment
FDA Submission Documents for Addi and Cassi’s Cyclodextrin Treatment
Ruyi He FDA response letter to clinical hold – 1-17-09
FDA Type A Meeting Request Letter from Dr. Hastings
FDA Letter Releasing Clinical Hold on Cyclodextrin Treatment For Addi and Cassi Hempel
Hydroxy Propel Beta Cyclodextrin (HPBCD) Summary/Overview
Cyclodextrin Safety Study in Rats and Dogs
PNAS paper by UT Southwestern researchers on cyclodextrin
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