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New Zealand’s GMO releases: Oncolytic viruses for cancer therapy clinical trials
Dr Tim Strabala, Principal Scientist, New Organisms
19 APRIL 2018
New Zealands GMO releases: Oncolytic viruses for cancer therapy - - PowerPoint PPT Presentation
New Zealands GMO releases: Oncolytic viruses for cancer therapy - - PowerPoint PPT Presentation
New Zealands GMO releases: Oncolytic viruses for cancer therapy clinical trials Dr Tim Strabala, Principal Scientist, New Organisms 19 APRIL 2018 1 Pexa- Vec: New Zealands first GM cancer therapy approval EPA approved October 2015,
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What is the benefit to New Zealand?
As at April 2016 (Baltimore, Chicago, Billings, Knoxville); https://clinicaltrials.gov/ct2/show/NCT02562755
- About 180 new HCC cases per year in NZ
- 3X more prevalent in men than women
- 5X more prevalent in Māori men than non-Māori
- 3X more prevalent in Māori women than non-Māori
PHOCUS trial (Sponsor – SillaJen)
- Global Phase 3 clinical trial
Why New Zealand?
- Rapid environmental assessment pathway
allowed two New Zealand sites to be among the first six sites to commence Pexa-Vec phase 3 trials for HCC1 (Now more than 100 around the world)
Pexa-Vec: New Zealand’s first GM cancer therapy approval
EPA approved October 2015, followed by Medsafe approval Trial commenced January 2016
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Variola (smallpox) virus Vaccinia virus
- Used to vaccinate against
smallpox (cross-protective)
- Administered to 100s of
millions of people
- Infection causes smallpox
- High mortality rate
- Global vaccination
programme eradicated variola in 1980
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Kim et al. (2006) Mol. Therapy 14:361
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Pexa-Vec
- A GM, viable vaccinia virus
- Disrupted thymidine kinase gene (selective
growth in cancer cells)
- Insert contains immune-stimulating genes, and
a “reporter” gene
- Conditional approval for clinical trials on liver
cancer
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Hernandez-Gea et al. (2013) J. Hepatology 59:882
7 Selective replication and tumour killing
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8 Human adenovirus 5
- “The common cold”
- Among the most
common human adenovirus types
- Most people have immunity
by age 5-7
- HAd-5 vectors used
extensively in gene therapy, cancer therapy
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9 Telomelysin
- A GM, viable adenovirus
- Changed regulation of early viral gene
expression
- No genes changed in the virus
- Virus replication is dependent on a protein
found at high levels in cancer cells
- Conditional approval for inoperable
melanoma
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Oncolys Biopharma website
10 Selective replication and oncolysis
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For more information contact:
General enquiries Phone +64 4 916 2426 Fax +64 4 914 0433 info@epa.govt.nz