A pdf file for the Gene Therapy protocols is found here:
nih.gov
For my own folder on TGEN I did a cut and paste of the
trials which contained Targeted Genetics, I think I
snagged most of them--the format and fonts will be lost
as I paste them in here, so you will want to visit the
NIH website. Also...at the moment I'm printing the
latest annual report of of targen.com--if I have a
chance I'll try to put together a little outline of
the most promising of TGEN's trials. It's been awhile
since I followed this one. Oh, also--regarding the stop
loss I mentioned in that previous post. Yeah, it was
hit allright. This has not been a good year for me--
good deeds do not go unpunished.
9409-083 (Open) Gene Therapy/Phase I/Monogenic Disease/Cystic Fibrosis
In Vivo/Nasal Epithelial Cells/Respiratory Epithelial Cells/Adeno-Associated Virus/Cystic Fibrosis Transmembrane Conductance Regulator
cDNA/Intranasal/Respiratory Tract Administration (Bronchoscope)
Zeitlin, Pamela L.; Johns Hopkins Childrens Center, Baltimore, Maryland; A Phase I Study of an Adeno-associated Virus-CFTR Gene Vector in Adult
CF Patients with Mild Lung Disease. Sponsor: Targeted Genetics Corporation
RAC Approval: 9-12-94/NIH Approval: 11-15-94
9508-119 (Open) Gene Therapy/Phase I/Human Immunodeficiency Virus-1
In Vitro/CD8+ Allogeneic Cytotoxic T Lymphocytes/CD8+ Syngeneic Cytotoxic T Lymphocytes/Retrovirus/Neomycin Phosphotransferase/
Herpes Simplex Virus Thymidine Kinase cDNA/Retrovirus/Intravenous
Riddell, Stanley R.; Fred Hutchinson Cancer Research Center, Seattle, Washington; Phase I Study to Evaluate the Safety of Cellular Adoptive
Immunotherapy using Autologous Unmodified and Genetically Modified CD8+ HIV-Specific T Cells in HIV Seropositive Individuals. Sponsor:
Targeted Genetics Corporation
Sole FDA Review Recommended by NIH/ORDA: 8-7-95
9507-114 (Open) Gene Therapy/Phase I-II/Monogenic Disease/Cystic Fibrosis
In Vivo/Maxillary Sinus Epithelial Cells/Adeno-Associated Virus/Cystic Fibrosis Transmembrane Conductance Regulator cDNA/Maxillary
Sinus Administration
Gardner, Phyllis; Stanford University School of Medicine, Stanford, California; A Phase I/II Study of tg-CF for the Treatment of Chronic Sinusitis in
Patients with Cystic Fibrosis. Sponsor: Targeted Genetics Corporation
Sole FDA Review Recommended by NIH/ORDA: 7-11-95
9512-137 (Open) Gene Therapy/Phase I/Cancer/Ovarian,Breast/Oncogene Regulation/HER-2/neu
In Vivo/Autologous Tumor Cells/Cationic Liposome Complex/DC-Chol-DOPE/E1A/Intraperitoneal, Intrapleural Administration
Hortobagyi, Gabriel N.; Lopez-Berstein, Gabriel; and Hung, Mien-Chien; MD Anderson Cancer Center, Houston, Texas; Kilbourn, Robert, Rush-Presbyterian/
St. Luke's Medical Center, Chicago, Illinois; Weiden, Paul; Virginia Mason Medical Center, Seattle, Washington; Phase I Study of E1A
Gene Therapy for Patients with Metastatic Breast or Ovarian Cancer that Overexpresses Her-2/neu. Sponsor: Targeted Genetics Corporation
RAC Approval: 12-4-95/NIH Approval: 2-2-96
9610-162 (Open) Gene Therapy/Phase I/Cancer/Solid Tumors/Oncogene Regulation/HER-2/neu/ In Vivo/Autologous Tumor Cells/Cationic
Liposome Complex/DC-Chol-DOPE/E1A/Intratumoral Injection
LaFollette, Suzanne; Rush/Presbyterian/St. Luke's Medical Center, Chicago, Illinois; Murray, James L.; M.D. Anderson Cancer Center, Houston,
Texas; Yoo, George; Wayne State University, Detroit, Michigan; A Phase I Multicenter Study of Intratumoral E1A Gene Therapy for Patients with
Unresectable or Metastatic Solid Tumors that Overexpress HER-2/neu. Sponsor: Targeted Genetics Corporation
Sole FDA Review Recommended by NIH/ORDA: 10-29-96
9703-182 (Open) Gene Therapy/Phase II/Monogenic Inherited Disorder/Cystic Fibrosis/Sinusitis/Correction/In Vivo/Maxillary Sinus
Epithelial Cells/ Adeno-associated Virus/Cystic Fibrosis Transmembrane Conductance Regulator cDNA/Maxillary Sinus Administration
Gardner, Phyllis; Stanford University's General Clinical Research Center (GCRC), Palo Alto, California; A Phase I/II Study of tgAAVCF for the
Treatment of Chronic Sinusitis With Cystic Fibrosis. Sponsor: Targeted Genetics Corporation
NIH/ORDA Receipt Date: 3-13-97. Sole FDA Review Recommended: 4-1-97
9804-245 (Open) Gene Therapy/Phase I/Monogenic Disease/Cystic Fibrosis/In Vivo/Adeno-Associated Virus/Cystic Fibrosis Transmembrane
Conductance Regulator (CFTR) cDNA/Aerosol Administration
Moss, Richard; Stanford University School of Medicine, Palo Alto, California; and Aitken, Moira, University of Washington Medical Center, Seattle,
Washington; A Phase I Study of Aerosolized tgAAVCF for the Treatment of Cystic Fibrosis Patients with Mild Lung Disease. Sponsor: Targeted
Genetics Corporation.
NIH/ORDA Receipt Date: 4-18-98. Sole FDA Review Recommended by NIH/ORDA: 12-3-98
9804-246 (Open) Gene Therapy/Phase II/Cancer/Squamous Cell Carcinoma of the Head and Neck/Oncogene Regulation/HER-2/neu/In Vivo/
Cationic Liposome Complex/DC-Chol-DOPE/E1A/Intratumoral Injection
Yoo, George H., Wayne State University School of Medicine, Detroit, Michigan; Villaret, Douglass B., University of Washington, Seattle, Washing-ton;
Gleich, Lyon, University of Cincinnati Medical Center, Cincinnati, Ohio; Hanna, Ehab, University of Arkansas Cancer Research Center, Little
Rock, Arkansas; and Kenady, Daniel E., and Valentino, Joseph, University of Kentucky, Lexington, Kentucky; A Multicenter Phase II Study of E1A
Lipid Complex for the Intratumoral Treatment of Patients with Recurrent Head and Neck Squamous Cell Carcinoma. Sponsor: Targeted Genetics
Corporation.
NIH/ORDA Receipt Date: 4-18-98. Sole FDA Review Recommended by NIH/ORDA: 2-1-99 |
