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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},
}