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@ARTICLE{Hajda:170408,
author = {J. Hajda and B. Leuchs$^*$ and A. L. Angelova$^*$ and V.
Frehtman$^*$ and J. Rommelaere$^*$ and M. Mertens and M.
Pilz and M. Kieser and O. Krebs and B. Huber and C.
Engeland$^*$ and A. Mavratzas and N. Hohmann and J.
Schreiber$^*$ and D. Jäger and N. Halama and O.
Sedlaczek$^*$ and M. M. Gaida and V. Daniel and C.
Springfeld and G. Ungerechts},
title = {{P}hase 2 trial of oncolytic {H}-1 parvovirus therapy shows
safety and immune cell activity in patients with metastatic
pancreatic ductal adenocarcinoma.},
journal = {Clinical cancer research},
volume = {27},
number = {20},
issn = {1557-3265},
address = {Philadelphia, Pa. [u.a.]},
publisher = {AACR},
reportid = {DKFZ-2021-01915},
pages = {5546-5556},
year = {2021},
note = {2021 Oct 15;27(20):5546-5556 / #LA:F230#},
abstract = {To investigate safety, clinical efficacy, virus
pharmacokinetics, shedding and immune response after
administration of an oncolytic parvovirus (H-1PV, ParvOryx)
to patients with metastatic pancreatic ductal adenocarcinoma
(PDAC) refractory to first-line therapy.This is a
non-controlled, single arm, open label, dose-escalating,
single center clinical trial. Seven patients with PDAC and
at least one liver metastasis were included. ParvOryx was
administered intravenously on four consecutive days and as
intralesional injection, six to thirteen days thereafter.
Altogether, three escalating dose levels were investigated.
In addition, gemcitabine treatment was initiated on day
28.ParvOryx showed excellent tolerability with no
dose-limiting toxicities. One patient had confirmed partial
response (PR) and one patient revealed unconfirmed PR
according to RECIST criteria. Both patients showed
remarkably long surivial of 326 and 555 days, respectively.
Investigation of pharmacokinetics and virus shedding
revealed dose-dependency with no excretion of active virus
particles in saliva or urine and very limited excretion in
feces. H-1PV nucleic acids were detected in tumor samples of
four patients. All patients showed T cell responses to viral
proteins. An interesting immunological pattern developed in
tumor tissues and in blood of both patients with partial
response suggesting immune activation after administration
of ParvOryx.The trial met all primary objectives, revealed
no environmental risks and indicated favorable immune
modulation after administration of ParvOryx. It can be
considered a good basis for further systematic clinical
development alone or in combination with immunomodulatory
compounds.},
cin = {F010 / F230 / E010},
ddc = {610},
cid = {I:(DE-He78)F010-20160331 / I:(DE-He78)F230-20160331 /
I:(DE-He78)E010-20160331},
pnm = {316 - Infektionen, Entzündung und Krebs (POF4-316)},
pid = {G:(DE-HGF)POF4-316},
typ = {PUB:(DE-HGF)16},
pubmed = {pmid:34426438},
doi = {10.1158/1078-0432.CCR-21-1020},
url = {https://inrepo02.dkfz.de/record/170408},
}