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947 gene directed enzyme prodrug therapy of human glioma xenografts using mutant escherichia coli cytosine deaminase

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Molecular Therapy Volume 13, Supplement 1, May 2006CANCER-APOPTOSIS AND SUICIDE Combined intratumoral injection of TRAIL plasmid and survivin antisense ODN significantly supressed the gr

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Molecular Therapy Volume 13, Supplement 1, May 2006

CANCER-APOPTOSIS AND SUICIDE

Combined intratumoral injection of TRAIL plasmid and survivin

antisense ODN significantly supressed the growth of tumor

xenografts in nude mice as compared to TRAIL plamid alone

(0.31±0.05 vs 2.35 ±0.38 cm3, P <0.01) during a 4-week of

observation Conclusions: The findings indicate that survivin may

play a role in tumor cell resistance to TRAIL-induced apoptosis, at

least in part, through cell cycle regulation Manipulation of survivin

expression may sensitizes HCC to TRAIL-induced apoptosis This

approach may offer a novel approach in molecular therapy against

HCC for which no effective treatment is available for an advanced

stage

945 Combination Treatment of Adenovirus

Mediated HSV-Thymidine Kinase Suicide Gene

Therapy and Docetaxel in Bladder Cancer

Hideyuki Yamashita,1 Weiguo Jian,1 April Gillbert,1 Seth P

Lerner.1

1 Scott Depertment of Urology, Baylor College of Medicine,

Houston, TX.

Purpose: The objective of this study was to evaluate the combined

effect of adenovirus vector encoding Herpes simplex thymidine

kinase plus ganciclovir (GCV) suicide gene therapy and Docetaxel

(DTX) in human bladder cancer cell lines

Material & Methods: IC50 was determined for both Ad5F35TK

plus ganciclovir (GCV) or DTX monotherapy at 48, 72 and 96 h

after exposure to a serial log-fold dosing of Ad5F35TK or DTX in a

coxsackievirus-adenovirus receptor (CAR) positive human bladder

cancer cell line (5637) and a CAR negative cell line (TCC-SUP) Cell

growth inhibition was then assessed at 72 h after treatment with

Ad5F35TK+GCV or Ad5F35TK/GCV/DTX by MTT assay

Ad5F35 and DTX were given within 3, 6, 9, 12, and 24 hours of

each other then MTT assay was performed at 72 h The viability of

control cells was set as 100%, and viability in other groups was

calculated by comparing the optical density (OD) readings with the

control

Results: The inhibitory concentration of docetaxel to achieve 50%

cell death in 5637 cell line ranged from 0.002 to 0.008 ug/ml and

from 0.002 to 0.02 in TCC-SUP cell line at 48, 72 and 96 hours

Adding docetexal chemotherapy to Ad5F35TK gene therapy

resulted in 57% benefit in 5637 cell line (p<0.0001) and 39% benefit

in TCC-SUP cell line (p<0.005)

Conclusion: Combination of Ad5F35TK+GCV suicide gene

therapy with DTX in human bladder cancer cells was considerably

more active in vitro than with monotherapy This result suggests

that combination treatment of Ad5F35TK+GCV suicide gene

therapy with DTX has the potential to enhance clinical activity as

compared to monotherapy in human bladder cancer

946 Effect of Androgen Receptor Suppression

Using Dominant Negative Inhibition on

Castration-Resistant Prostate Cancer

Brian J Zeithaml,1 Mark Titus,2 Karin Haack,1 Adam Cockrell,1

Angela Ponguta,2 Elizabeth Wilson,2 James Mohler,3 Tal Kafri.1

1 Gene Therapy Center, University of North Carolina at Chapell

Hill, Chapel Hill, NC; 2 Linberger Comprehensive Cancer Center,

University of North Carolina Chape Hill, Chapel Hill, NC;

3 Roswell Park Cancer Institute, Buffalo, NY.

An American dies from CaP every 17 minutes Advanced prostate

cancer almost always responds to androgen deprivation therapy

but inevitably recurs as castration-resistant prostate cancer Recent

evidence suggests that the growth of most cases of castration-resistant

prostate cancer depends upon androgen receptor (AR) activation1

and that AR activation may be due to a combination of AR

hypersensitization2-6 and low levels of dihydrotestosterone and/or

testosterone (DHT/T), 7,8 intracellular testicular androgens produced by intracrine metabolism from cholesterol or adrenal androgens The role of AR in castration-resistant prostate cancer can be studied using an AR dominant negative mutant, ∆TR (Wilson unpublished) and CWR-R1, a castration-resistant prostate cancer cell line9 ∆TR contains a deletion in the NH2-terminal region that results in loss of the AR transactivating domain and inhibits wild type AR possibly due to dimerization and loss of binding of one or more coactivators Activation of ∆TR appears to require binding of DHT and/or T for interaction with and transactivational inhibition

of endogeneous AR Past evidence reveals that CWR-R1 cells express high levels of AR, grow in the absence of DHT/T when supplemented with EGF, and increase cell proliferation when supplied with DHT9 Suppressing AR using ∆TR delivered via lentiviral vectors tested the hypothesis that CaP recurrence can be delayed or prevented by interfering with AR function Lentiviral vectors achieved high level

AR-regulated gene product) expression, decreased plasmid luciferase expression from the MMTV promoter (an AR target promoter), decreased CWR-R1 cell proliferation in culture, and inhibited xenografted CWR-R1 tumor growth in castrated mice with DHT pellet implants (all unpublished) ∆TR must require higher amounts

of DHT or other cofactors than AR for activation since in vivo CWR-R1 tumor growth rates were slowed but not eliminated To address this question, ligand-independent shRNA will be used to

dimerization and effect CWR-R1 proliferation and in vivo tumor growth of the ∆TR-transduced and AR-targeted shRNA-transduced cells will further enlarge our understanding of the role of AR in castration-resistant prostate cancer

1Debes JD and Tindall DJ (2004) N Engl J Med 315, 1488-90 2Tapin ME et al (1995) N Engl J Med 332, 1392-8

3Shi X et al (2002) Cancer Res 62, 1496-1502

4Culig Z et al (1993) Mol Endocrinol 7, 1541-50

5Peterziel H et al (1995) Int J Cancer 63, 544-50

6Tan JA et al (1997) Mol Endocrinol 11, 450-9

7Mohler JL et al (2004) Clin Cancer Res 10, 440-48

8Titus MA et al (2005) Clin Cancer Res 11, 4365-71 9Gregory CW et al (2001) Cancer Res 61, 2892-8

947 Gene Directed Enzyme/Prodrug Therapy

of Human Glioma Xenografts Using Mutant Escherichia coli Cytosine Deaminase

Sergey A Kaliberov,1 Valentina Krendelchtchikova,1 Debbie Della Manna,1 Jeffrey C Sellers,1 Lyudmila N Kaliberova,1 Margaret

E Black,2 Donald J Buchsbaum.1

1 Department of Radiation Oncology, University of Alabama at Birmingham, Birmingham, AL; 2 Department of Pharmaceutical Sciences and the School of Molecular Biosciences, Washington State University, Pullman, WA.

Combined treatment using suicide gene therapy and radiation therapy has the potential to become a powerful new method of cancer therapy We have developed a non-replicative adenoviral vector encoding a mutant bacterial cytosine deaminase (bCD) gene harboring substitution of an alanine (A) for the aspartic acid (D) at position 314 in the CD protein (AdCD-D314A) which has a higher affinity for 5-fluorocytosine (5-FC) than wild type bCD (CDwt)

The purpose of this study was to evaluate cytotoxicity in vitro and therapeutic efficacy in vivo of the combination of AdCD-D314A

with the prodrug 5-FC and radiation treatment (RT) against human glioma The results of CD enzyme activity assays showed that the conversion of 3H-5-FC to 3H-5-FU was elevated 183.3, 205.6 and 102.2-fold in D54MG, U87MG and U251MG human glioma cells, respectively, for cells infected with 2 multiplicity of infection (MOI)

of AdCD-D314A compared to AdCDwt AdCD-D314A infection

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Molecular Therapy Volume 13, Supplement 1, May 2006 Copyright  The American Society of Gene Therapy

S366

CANCER-TARGETED GENE THERAPY: OTHER VIRUSES AND NEW APPROACHES

also resulted in increased 5-FC-mediated cell killing The 50%

inhibitory concentration produced by 5-FC decreased by 7.8-fold

for D54MG, 32.9-fold for U87MG, and 8.1-fold for U251MG cells

infected with 10 MOI of AdCD-D341A in comparison with

AdCDwt Animal studies showed significant inhibition of tumor

growth of D54MG glioma subcutaneous xenografts by the

combination of AdCD-D314A/5-FC with RT as compared with

either agent alone, or with AdCDwt/5-FC plus RT The results

demonstrate that the combination of AdCD-D314A/5-FC with

radiation produces markedly increased cytotoxicity in cancer cells

in vitro and in vivo compared to AdCDwt These data indicate that

combined treatment with this novel mutant enzyme/prodrug therapy

and radiotherapy provides a promising approach for glioma therapy

CANCER-TARGETED GENE THERAPY: OTHER VIRUSES

AND NEW APPROACHES

948 Rapid Production of Specific Artificial

Meganucleases for Gene Correction in Patients

with Inherited Disease

Philippe Duchateau, Patrick Chames, Jean-Charles Epinat,

Arnould Sylvain, Julie Smith, Agnes Gouble, Christophe Perez,

Sylvestre Grizot, Frederic Paques

1 Research, Cellectis SA, Romainville, France.

Meganucleases are sequence-specific endonucleases recognizing

large (>14 bp) sequences Because of this unusual specificity,

meganuclease have emerged as powerful tools for genome engineering:

creation of double-strand breaks by meganucleases at specific loci

can be used to enhance homologous gene targeting by several orders

of magnitude in mammalian and plant cells Recently, such proteins

could be used to induce gene repair in mouse hepatocytes, paving

the way for a novel strategy for inherited diseases therapy based on

gene correction instead of complementation Thus, the generation of

meganucleases with tailored specificities is under intense

investigation A major issue is whether it is possible to obtain novel

dedicated endonuclease which levels of specificity compatible with

the high requirements of therapeutic applications

Homing endonucleases (HEs) are natural meganucleases encoded

by mobile genetic elements such as class I introns and inteins Their

exquisite specificity identifies them as ideal scaffolds to derive novel

meganucleases with engineered DNA binding domains HEs from

the LAGLIDADG family, the largest and most widespread family

of HEs, display two independent domains or units Moreover,

despite the lack of apparent additional modularity at the structural

level, we have identified separable functional subdomains within a

same LAGLIDADG domain binding distinct parts of the DNA

target Using a semi-rational approach, we have used a two steps

strategy to produce meganucleases cleaving natural genes In a first

step, we have derived hundreds of novel meganucleases with novel

specificities from I-CreI, a natural homodimeric homing

endonuclease In a second step, a combinatorial approach allows us

to assemble these I-CreI variants into novel meganucleases with

predictable cleavage site Importantly, these proteins have retained

high levels of specificity Examples of meganucleases with potential

therapeutic applications will be disclosed

949 Oncolytic Autonomous Parvovirus (rH1-yCD) Targeting with P4/Carcinoembryonic Antigen Chimeric Promoter for Virotherapy of Pancreatic Cancer

Soukaina Rejiba, Marc Aprahamian, Amor Hajri

1 Tumor Biology & Gene Therapy, IRCAD - INSERM U701, Strasbourg, France; 2 Tumor Biology & Gene Therapy, IRCAD -INSERM U701, Strasbourg, Finland; 3 Tumor Biology & Gene Therapy, IRCAD - INSERM U701, Strasbourg, France.

Background: Successful gene therapy depends on the

development of safe and efficient vectors for gene expression targeting We investigated the use of a rH1CEA-yCD recombinant parvoviral vector, bearing the yeast cytosine deaminase (yCD) suicide gene The parvoviral P4 promoter was modified by the addition of

a 319 bp Carcinoembryonic Antigen (CEA) tissue-specific promoter sequence, to improve the oncotropic and oncolytic intrinsic properties of the autonomous H-1 parvovirus

Material && Methods: To this end, we explored in vitro, the

ability of this rH1CEA-yCD virus to infect CEA-producing cell line (BxPc3) and CEA-nonproducing cell lines (HA-HPC and HeLa) The suicide gene expression was evaluated by RT-PCR and western

blotting The cytotoxicity effect was measured by MTT test For in

vivo experiments, we evaluated the oncolytic efficacy of this new

recombinant parvovirus on tumor growth upon subcutaneous/ peritoneal pancreatic carcinomatosis models in nude mice

Results: Our data indicate that rH1CEA-yCD infect efficiently

the tumor cell lines in the same manner as its parental rH1-yCD RT-PCR and western blot analyses showed a down-regulation of the expression of both the NS1 (viral gene) and the yCD (suicide gene) brought by rH1CEA-yCD in HA-HPC and HeLa cell lines, when compared with rH1-yCD With regard to its cytotoxic effect, rH1CEA-yCD/ 5-FC treatment was incapable to induce cell death

in those cell lines, but was as efficient as rH1-yCD to kill BxPc3 cell

line In vivo, infection with rH1CEA-yCD led to significant

retardation of BxPc3 tumor growth both in subcutaneous and intraperitoneal disseminated pancreatic models The survival rate of animals bearing CEA-producing cell lines (BxPc3) was improved (p<0.001) However, there was no effect on HA-HPC tumor models

Conclusion: In summary, we have developed a new targeted

recombinant parvovirus where the parvoviral oncolytic effect and the suicide gene expression are tightly restricted to tumor cells with CEA tumor marker promoter signaling

Cancer

Maria Rajecki,1,2 Lotta Kangasniemi,1,2 Mikko Tenhunen,2 Anna Kanerva,1,2,3 Renee A Desmond,4 Ulf-Hakan Stenman,5 Martti Y Ala-Opas,6 Akseli Hemminki.1,2

1 Rational Drug Design Program, University of Helsinki, Helsinki, Finland; 2 Department of Oncology, HUCH, Helsinki, Finland;

3 Department of Obstetrics and Gynecology, HUCH, Helsinki, Finland; 4 Comprehensive Cancer Center, Biostatistics and Bioinformatics Unit, University of Alabama at Birmingham, Birmingham, AL; 5 Department of Clinical Chemistry, HUCH, Helsinki, Finland; 6 Department of Urology, HUCH, Helsinki, Finland.

Background: Hormone refractory metastatic prostate cancer

(PrCa) remains incurable Conditionally replicating adenoviruses (CRAds) are attractive therapeutic agents for cancer due to their innate capacity for oncolysis Transduction efficacy of native

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