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Table 2: Clinical data on the approved gene therapy clinical trials in Belgium
(Authors: M. Sneyers and M. Goossens - Last revised: July 28, 2010 )

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Indication category

Disease

Therapeutic approach

Transferred nucleic acid

Method of transfer

Administered biological material

Route of administration

B-GT/1

Cancer therapy

Newly diagnosed or recurrent Glioblastoma multiforme

Suicide gene/ pro drug

Thymidine Kinase (HSV-TK1), neomycin resistance (NeoR)

Amphotropic Murine Leukemia Virus

Retroviral vector producing cells (PA 317)

Intratumoral

B-GT/2

Cancer therapy

Newly diagnosed previously untreated Glioblastoma

Suicide gene/ pro drug

Thymidine Kinase (HSV-TK1), neomycin resistance (NeoR)

Amphotropic Murine Leukemia Virus

Retroviral vector producing cells (PA 317)

Intratumoral

B-GT/3

Cancer therapy

Squamous cell carcinoma of the Head and Neck

Tumor suppressor gene

Wild-type p53

Human Adenovirus serotype 5

Recombinant Adenovirus
D (E3, E1A, E1B, pIX)

Intratumoral

B-GT/4

Cancer therapy

Non-Small Cell Lung Cancer

Tumor suppressor gene

Wild-type p53

Human Adenovirus serotype 5

Recombinant Adenovirus
D (E3, E1A, E1B, pIX)

Intratumoral

B-GT/5
Cancer therapy

Malignant melanoma, Non-Small Cell Lung Cancer,
Squamous cell carcinoma of the Head and Neck, Bladder transitional cell carcinoma

Immunotherapy

HLA-A1 restricted CTL epitope of MAGE-1 and
MAGE-3 genes

Canarypox Virus (ALVAC)
Recombinant Canarypox Virus
Intradermal/ Subcutaneous

B-GT/6

Cancer therapy

Metastatic adenocarcinoma of the Breast

Immunotherapy

Muc-1 and Interleukine 2 (IL-2)

Attenuated Vaccinia Virus (Copenhagen Strain)

Recombinant Attenuated Vaccinia Virus

Intramuscular

B-GT/7

Cancer therapy

Recurrent squamous cell carcinoma of the Head and Neck

Tumor suppressor gene

Wild-type p53

Human Adenovirus serotype 5

Recombinant Adenovirus
D (E3, E1A, E1B)

Intratumoral

B-GT/8
Cancer therapy
Ovarian and primary peritoneal cancer
Tumor suppressor gene
Wild-type p53
Human Adenovirus serotype 5
Recombinant Adenovirus
D (E3, E1A, E1B, pIX)
Intraperitoneal
B-GT/9
Cancer therapy
Non-hematologic malignancies
Tumor colonization
Not relevant
Not relevant
Genetically modified Salmonella typhimurium bacillus
Intratumoral
B-GT/10
Infectious disease
AIDS
Immunotherapy
vCP-1452
Attenuated Canarypox Virus (ALVAC)
Recombinant Canarypox Virus
Intramuscular
B-GT/11
Cancer therapy
Metastatic Breast Cancer
Immunotherapy
Muc-1 and Interleukine 2 (IL-2)
Attenuated Vaccinia Virus (Ankara Strain)
Recombinant Attenuated Vaccinia Virus
Subcutaneous
B-GT/12
Cancer therapy
Non-Small Cell Lung cancer
Immunotherapy
Muc-1 and Interleukine 2 (IL-2)
Attenuated Vaccinia Virus (Ankara Strain)
Recombinant Attenuated Vaccinia Virus
Subcutaneous
B-GT/13
Cancer therapy
Refractory squamous cell carcinoma of the Head and Neck
Tumor suppressor gene
Wild-type p53
Human Adenovirus serotype 5
Recombinant Adenovirus
D (E3, E1A, E1B)
Intratumoral
B-GT/14
Cancer therapy
Recurrent squamous cell carcinoma of the Head and Neck
Tumor suppressor gene
Wild-type p53
Human Adenovirus serotype 5
Recombinant Adenovirus
D (E3, E1A, E1B)
Intratumoral
B-GT/15
Cancer therapy
Progressive metastatic renal cell carcinoma
Immunotherapy
Muc-1 and Interleukine 2 (IL-2)
Attenuated Vaccinia Virus (Ankara Strain)
Recombinant Attenuated Vaccinia Virus
Subcutaneous
B-GT/16
Cardiovascular therapy
Chronic angina pectoris
Gene therapy
human FGF-4
Human Adenovirus serotype 5
Recombinant Adenovirus
D (E1A, E1B)
Intracoronary
Infectious disease
AIDS
Immunotherapy
genes for the gag, protease and part of the reverse transcriptase proteins of HIV-1
Adeno Associated Virus serotype 2
Recombinant Adeno Associated Virus
D (rep, cap)
Intramuscular
Cancer therapy
Metastatic melanoma or other advanced solid tumors
Immunotherapy
Interleukine 2 (IL-2)
Human Adenovirus serotype 5
Recombinant Adenovirus
D (E1, E3)
Intratumoral
B-GT/19 Cancer therapy
Operable high-grade glioma
Suicide gene/ pro drug
Thymidine Kinase (HSV-TK1)
Human Adenovirus serotype 5
Recombinant Adenovirus
D (E1, E3)
Intratumoral
Cardiovascular therapy
Stable angina pectoris
Gene therapy
human VEGF121
Human Adenovirus serotype 5
Recombinant Adenovirus
D (E1a and partially E1b and E3)
Intracardiac
Gastrointestinal disorders
Ulcerative colitis
anti-inflammatory treatment
human Interleukine 10 (HIl10)
Lactococcus lactis strainMG1363
Recombinant Lactococcus lactis D (thy A)
oral and rectal
Hepatic disorders
Chronic hepatitis B
Immunotherapy
Hepatitis B virus polyepitope gene
Attenuated Vaccinia virus strain MVATGN33
Recombinant Attenuated Vaccinia Virus
subcutaneous
B-GT/23 Infectious disease lower respiratory tract illness Immunotherapy

genes expressing
-hPIV3 fusion protein
-RSV fusion protein
-hemagglutinin-neuraminidase

Attenuated Bovine Parainfluneza Virus type 3
strain bPIV3/15626/84

 

Recombinant Attenuated Bovine Parainfluneza Virus intranasal
Cancer therapy cervical neoplasia Immunotherapy -E6 and E7 genes from HPV
-Interleukine 2 (IL-2)

Attenuated Vaccinia virus strain MVATGN33 Recombinant Attenuated Vaccinia virus subcutaneous
B-GT/25 Infectious disease AIDS Immunotherapy Gag, Pol, Nef genes of HIV Attenuated measles virus
Schwarz strain

Recombinant attenuated measles virus

intramuscular

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