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Table 2: Clinical data on the approved gene therapy clinical trials in Belgium
(Last revised: March 14, 2016 )

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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

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

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
Cancer therapy
Non-hematologic malignancies
Tumor colonization
Not relevant
Not relevant
Genetically modified Salmonella typhimurium bacillus
Intratumoral
Infectious disease
AIDS
Immunotherapy
vCP-1452
Attenuated Canarypox Virus (ALVAC)
Recombinant Canarypox Virus
Intramuscular
Cancer therapy
Metastatic Breast Cancer
Immunotherapy
Muc-1 and Interleukine 2 (IL-2)
Attenuated Vaccinia Virus (Ankara Strain)
Recombinant Attenuated Vaccinia Virus
Subcutaneous
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
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
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
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
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
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
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
Infectious disease AIDS Immunotherapy Gag, Pol, Nef genes of HIV Attenuated measles virus
Schwarz strain

Recombinant attenuated measles virus

intramuscular
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
Cancer therapy Acute leukemia Restore immunity + treatment of GVHD -Thymidine Kinase (HSV-Tk)
- selection marker
Moloney Murine Leukemia virus
haploidentical donor
T-lymphocytes expressing HSV-Tk
intravenous
Cancer therapy
Radiotherapy-induced oral mucositis
Prevention
Human Trefoil Factor 1
Lactococcus lactis strainMG1363
Recombinant Lactococcus (sAGX0085)
oral mouth rinse
Cancer therapy Castrate-resistant prostate cancer Immunotherapy - prostate specific antigen (PSA)
- 3 costimulatory molecules
Attenuated Vaccinia Virus (NYCBH Strain)
+
Attenuated Fowlpox Virus
Recombinant Attenuated Vaccinia Virus
+
Recombinant Attenuated Fowlpox Virus

subcutaneous
Infectious disease AIDS
Immunotherapy
artificial gene expressing Gag, Pol, Nef antigens of HIV
NL4-3 strain of HIV-1
non replication comptent lentivirus
intramuscular
B-GT/31 Cardiovascular therapy Heart failure
Gene therapy
Human SERCA2a
Adeno Associated Virus serotype 1
Recombinant AAV1
intracoronary
B-GT/32 Gastrointestinal disorders Inflammatory bowel disease
Immunotherapy
gene expressing certolizumab
Lactococcus lactis strain MG1363
Recombinant Lactococcus (sAGX0354)
oral
Cancer therapy
Melanoma
Immunotherapy
gene expressing h GM-CSF
HSV-1
Recombinant HSV-1 D(ICP34,5 & ICP47)
intralesional
B-GT/34 Cancer therapy Melanoma
Immunotherapy
gene expressing h GM-CSF
HSV-1
Recombinant HSV-1 D(ICP34,5 & ICP47)
intralesional
B-GT/35 Cancer therapy Metastatic Squamous Cell Carcinoma of the Head and Neck
Immunotherapy
gene expressing h GM-CSF
HSV-1
Recombinant HSV-1 D(ICP34,5 & ICP47)
intralesional

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