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744 improvement of the TKGCV strategy for the treatment of gliomas by 5 fluorouracil and TK30, a more potent TK enzyme

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744 Improvement of the TK/GCV Strategy for the Treatment of Gliomas by 5 Fluorouracil and TK30, a More Potent TK Enzyme Molecular Therapy �������� ��� ���� ���������������� �������� ��� ������© ������[.]

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Molecular Therapy Vol 7, No 5, May 2003, Part 2 of 2 Parts

ONCOLYTIC VIRUS AND SUICIDE GENE THERAPY FOR CANCER isogenic tk vector (TOZ.1) in the presence or absence of GCV

bioactivity to inhibit the NF-κB translocation to the nucleus was

examined by electrophoretic motility shift assay In human

already been translocated in the nucleus without receptor mediated

the translocation of NF-κB was significantly inhibited, and the

caspase 3 activity was found to be significantly upregulated in

infected cells At an MOI of 0.1, the cytotoxicity against U-87MG

killed 85% of U-87MG cells, and in the presence of GCV, all the

translocated to the nucleus, cells had become apoptotic by infection

enhanced the cytotoxicity by the bystander effects of HSV-TK/

GCV system

Apoptosis in Lung Cancer Cells

Katherine M Finan,1 Greg Hodge,2 Ann M Reynolds,1 Sandra

Hodge,1 Mark D Holmes,1 Andrew H Baker,3 Paul N

Reynolds.1

1 Department of Thoracic Medicine, Royal Adelaide Hospital,

Adelaide, South Australia, Australia; 2 Department of

Haematology, Women’s and Children’s Hospital, Adelaide, South

Australia, Australia; 3 Division of Cardiovascular and Medical

Sciences, University of Glasgow, Glasgow, Scotland, United

Kingdom.

New options are needed for the treatment of advanced lung cancer

Tumour invasion and spread involves a complex interplay between

tumour, stromal and inflammatory cells with the extracellular matrix

(ECM) The matrix metalloproteinases (MMPs) are a family of

enzymes involved in ECM maintenance and tissue inhibitors of

matrix metalloproteinases (TIMPs) are important factors in the

regulation of the activity of MMPs Gene delivery of TIMP 1 and

2 has been shown to inhibit tumour growth in animal models There

is evidence that TIMP 3 may also be therapeutic in this way, and in

contrast to TIMP 1 and 2, may directly induce apoptosis in tumour

cells, although this has not yet been evaluated in lung cancer

Hypothesis: Overexpression of TIMP 3 delivered by adenoviral

(Ad) vectors to lung cancer cells causes apoptosis and increased cell

death Aims: To compare the effect of TIMP 1, 2 and 3 gene delivery

on lung cancer cell lines Methods: A549, 1299, H1466 and 522

cells were plated at a known concentration, then infected with Ad

vectors carrying the genes for TIMP 1, 2 and 3 Following infection

the cells were examined for changes consistent with apoptosis and

cell death Analysis by flow cytometry using Propidium Iodide and

Anexin V staining was used to establish the presence of apoptosis

Cell counts were used to evaluate any reduction in cell number

Results: For all lines maximal reduction in cell number was seen

with TIMP 3 overexpression and this was dose dependent Flow

cytometry confirmed the induction of apoptosis by TIMP 3 (eg for

A549 cells 32.5 ± 6.3% at 72 hours vs 2.2 ± 2.1% for uninfected

cells) Rates of apoptosis with TIMP 1 and 2 infected cells were

similar to controls Conclusion: TIMP 3 induces a reduction in cell

numbers and causes increased apoptosis in lung cancer cell lines

Further study using animal models of lung cancer is thus warranted

and is currently being pursued

in Combination with Cell Cycle-Altering Drugs

Tiina Pasanen,1 Anne Karppinen,1 Leena Alhonen,1 Juhani Jänne,1 Jarmo Wahlfors.1

1 Department of Biotechnology and Molecular Medicine, A.I Virtanen Institute for Molecular Scieces, Kuopio, Finland.

Suicide gene therapy with HSV-TK and ganciclovir (GCV) has been widely used against malignant cells and its efficacy has been demonstrated in a variety of different in vitro and in vivo models However this gene therapy regimen needs to be enhanced for a true clinical success We studied whether polyamine biosynthesis inhibition by 2-difluoromethylornithine (DFMO), a clinically tested and well-tolerated chemotherapeutic drug, can increase the cytotoxicity of HSV-TK/GCV in 9L rat glioma cells Polyamines putrescine, spermidine and spermine are cationic molecules that are indispensable to cell growth and differentiation The hypothesis was that prolonged S-phase caused by polyamine biosynthesis inhibition, would lead to accumulation of cells in this particular cell cycle phase When the cells are released from this block, there would

be higher proportion of cells in the middle of DNA-synthesis phase Because HSV-TK/GCV cytotoxicity is killing cells only after their DNA has been replicated, the preceding DFMO treatment would make the cell destruction more efficient When the cells were exposed

to GCV 3 or 4 days after removal of DFMO from growth medium, the cytotoxicity was increased up to 2.5-fold We also verified whether cell cycle blockage per se could yield similar effect as DFMO Our results from serum deprivation experiments showed that, despite of apparent cell growth and cell cycle phase distribution effects, serum starvation was weaker enhancer of HSV-TK/GCV cytotoxicity than DFMO Finally, the general utility of HSV-TK/ GCV DFMO combination was tested in another tumor cell type, human prostate carcinoma cell line DU-145 DFMO sensitized these cells to HSV-TK/ GCV cytotoxicity, but the effect was less prominent than in 9L cells In conclusion, we have demonstrated that a correctly timed induction of DFMO-mediated polyamine biosynthesis inhibition can enhance the efficiency of HSV-TK/GCV gene therapy in vitro The observed synergistic effect is potentially useful in clinical trials because, as opposed to use of other cell cycle-altering drugs, DFMO has already been tested in the treatment of human tumors and used as chemo preventive regimen with excellent tolerability We are currently testing whether other cell cycle-altering drugs can enhance ganciclovir-mediated cytotoxicity Furthermore, DFMO treatment in combination with HSVtk/GCV therapy will be tested in vivo

the Treatment of Gliomas by 5-Fluorouracil and TK30, a More Potent TK Enzyme

Gaelle V Roullin,1 Emmanuelle F Germain,1 Manuel P Caruso.1

1 Cancer Research Center, Laval University, Quebec, QC, Canada.

BACKGROUND: Gene transfer of the Herpes Simplex virus thymidine kinase (TK) associated with gangiclovir (GCV) administration represents a promising approach to treat malignant gliomas TK phosphorylates GCV into GCV-monophosphate, which

is further converted into the di- and triphosphate forms by cellular enzymes GCV-triphosphate is incorporated into elongating DNA, which leads to cell death Complete tumor eradication has been obtained in animal experiments with only a small proportion of cells expressing TK (TK cells) This phenomenon, called the bystander effect (BE), is mainly due to the transfer of phosphorylated GCV from TK cells to neighbouring TK negative cells In clinical trials, the low level of gene transfer and inhomogeneous distribution of the vector within the tumor, have been highlighted Moreover, an effective

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Molecular Therapy Vol 7, No 5, May 2003, Part 2 of 2 Parts

Copyright © The American Society of Gene Therapy

S288

ONCOLYTIC VIRUS AND SUICIDE GENE THERAPY FOR CANCER

drug concentration is difficult to obtain in the vicinity of the tumor

since GCV does not cross readily the blood brain barrier We have

previously reported a major improvement by using TK30, a much

more potent mutant of TK: TK30-expressing cells (TK30 cells)

were killed more efficiently than TK cells (10- to 100-fold) and the

BE was strongly increased too The use of 5-fluorouracil (FU) has

been shown by others to enhance the efficacy of the TK/GCV

strategy FU is a thymidylate synthase inhibitor which acts by

decreasing the pools of thymidine, the major competitor for GCV

phosphorylation In this study, we have investigated the potential

of FU to interact with GCV on four different human (SKI1, SKMG4,

U87 and U251) and three rat (C6, F98 and 9L) TK- or TK30 glioma

cells

METHODS: The various cell lines were retrovirally infected to

stably express the mutant TK30 or the wild-type TK Drug

sensitivities were determined by their median inhibitory

concentration (IC50) using conventional MTT proliferation assays

BE experiments with either TK30 or TK were realized by mixing

ratios of infected and non-infected cells The multiple drug-effect

analysis of Chou-Talalay was used to qualify the interaction between

GCV and FU

RESULTS: As calculated by the Chou-Talalay method, at least

an additive effect of the drugs was noted in proliferation experiments

with all glioma TK30 cells In BE experiments carried out with SKI1

and SKMG4 cells, potentiation and/or synergism were observed

and the synergism was stronger in TK- than in TK30 cells

Nevertheless, the IC50 (GCV) was still much lower with TK30- vs

TK cells in the presence of FU (by a factor of 35 and 126 for SKI1

and SKMG4, respectively) Interestingly, except for U251 cells, a

strong synergistic effect was also found when non-infected cells

alone were treated with GCV + FU, a phenomenon unreported until

now The mechanisms of this antitumor effect as well as in vivo

studies are presently under investigation

CONCLUSION: Based on these data, the local delivery of GCV

+ FU associated with TK30 gene transfer should be considered to

optimize the TK/GCV strategy by efficiently eliminating both

infected and more importantly non-infected glioma cells In vivo

experiments will address the antitumoral efficacy of this system

and also the possible loco-regional toxic side effects of the drug

combination

CANCER TARGETED GENE THERAPY II

Chemotherapy for Cancer Treatment

Ziqun Han,1 Jennifer Hu,2 Binlei Liu,1 Michael Robinson,1 Ruth

Branston,1 Charles Coombes,2 Robert Coffin.1

1 BioVex Ltd, Abingdon, Oxon, United Kingdom; 2 Cancer Cell

Biology, Hammermsith Hospital Campus, Imperial College of

Science and Medicine, London, United Kingdom.

OncoVEX is an oncolytic version of HSV with several

improvements as compared to oncolytic versions of HSV previously

tested in the clinic These improvements are (i) OncoVEX is derived

from a clinical isolate of HSV with enhanced anti-tumour potency

as compared to previously used laboratory strains (ii) tumour

selective replication is enhanced via increased expression of US11 in

addition to deletion of ICP34.5 (iii) ICP47, which usually blocks

antigen presentation in HSV infected cells, is deleted A version of

this virus additionally encoding the gene for GM-CSF is currently

in a Phase I clinical trial in a number of tumour types This virus is

designed to provide a direct anti-tumour effect by tumour selective

virus replication and also to induce an anti-tumour immune response

enhanced by the expression of GM-CSF It is anticipated that in

routine clinical practice oncolytic viruses are likely to be combined

with standard therapies such as chemo- or radiotherapy The work

reported here assesses the anti-tumour effects of OncoVEX in combination with a number of first line chemotherapeutic agents

(e.g taxol and cisplatin) in in vitro models Work in vivo is underway.

Results so far demonstrate that OncoVEX treatment of tumour cells either prior to, concurrently with, or after addition of the drug provides enhanced drug sensitivity and that the chemotherapeutic agents tested do not reduce the effectiveness of the oncolytic effect Initial conclusions are therefore that combination of OncoVEX with anti-cancer drug therapy may be beneficial for cancer treatment

Cancer with an Oncolytic Herpes Simplex Virus Incorporating Two Membrane-Fusion Mechanisms

Mikihito Nakamori,1 Xinping Fu,1 Feng Meng,1 Aiwu Jin,1 Lihua Tao,1 Robert C Bast, Jr.,2 Xiaoliu Zhang.1

1 Center for Cell and Gene Therapy, Baylor College of Medicine, Houston, TX; 2 M.D.Anderson Cancer Center, The University of Texas, Houston, TX.

Replication-competent herpes simplex virus (oncolytic HSV) holds considerable promise for treating malignant solid tumors including ovarian cancer However, the potency of the virus needs improvement if its full clinical potential is to be realized In our previous studies, we showed that incorporation of membrane fusion capability into an oncolytic HSV, either by screening for a syncytial HSV mutant after random mutagenesis or by inserting a hyperfusogenic glycoprotein from gibbon ape leukemia virus (GALV.fus) into the viral genome, can significantly increase the antitumor capability of the virus We recently constructed a newer version of fusogenic oncolytic HSV by incorporating both membrane fusion mechanisms into a single virus In vitro characterization of this doubly fusogenic oncolytic HSV (Synco-2D) showed that this virus produces a distinctive syncytial phenotype, leading to a significantly increased tumor cell killing ability, compared with that

of a nonfusogenic virus When injected directly into the abdominal cavity of mice bearing human ovarian cancer xenografts, Synco-2D eradicated all tumor masses in 75% of the animals, whereas no animals in the conventional oncolytic HSV treated group was tumor-free Our results indicate that this newly generated fusogenic oncolytic HSV is a promising candidate for clinical testing against advanced ovarian cancer

Oligonucleotides and siRNAs Strategies in Human Pancreatic Cancer

Amor Hajri, Hazare Nouari, Severine Wack, Marc Aprahamian

1 Tumor Biology and Gene Therapy Dept., IRCAD-INSERM U375, Strasbourg, France.

Human pancreatic cancer is an extremely aggressive and incurable carcinoma because of its poor sensitivity to chemotherapy and/or radiotherapy Point mutations of the K-ras gene are detected in > 90% of human pancreatic cancers and may play an important role in tumorigenesis Antisense therapeutics with phosphorothioate oligonucleotides (PS ODN) and short interfering RNAs (siRNA) targeting specific gene expression represent a promising strategy for pancreatic cancer treatment The aim of the present work was to address a comparative study concerning the antitumor activity of synthetic PS-ODN and siRNA antisense targeting specific k-ras

mutation (k-Ras mut12) The siRNA was delivered as a synthetic

19-22 bases and as a recombinant vector for stable expression The

antitumor activity was evaluated (i) in vitro, in cell culture with

different human pancreatic cancer cell lines (BxPc3, Panc1, Capan1) The endogenous Ras expression was determined by RT-PCR and Western-blotting Antiproliferative and cytotoxic effects were

evaluated by [3H] thymidine incorporation and MTT tests (ii) In

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