Pre-Clinical Publications

Pre-Clinical Publications

A novel oncolytic viral therapy and imaging technique for gastric cancer using a genetically engineered vaccinia virus carrying the human sodium iodide symporter
Journal of Experimental & Clinical Cancer Research 2014, 33:2.
Kyong-Hwa Jun, Sepideh Gholami, Tae-Jin Song, Joyce Au, Dana Haddad, Joshua Carson, Chun-Hao Chen, Kelly Mojica, Pat Zanzonico, Nanhai G Chen, Qian Zhang, Aladar Szalay and Yuman Fong.


Growth inhibition of different human colorectal cancer xenografts after a single intravenous injection of oncolytic vaccinia virus GLV-1 h68
J Transl Med. 2013 Mar 26;11(1):79.
Ehrig K, Kilinc MO, Chen NG, Stritzker J, Buckel L, Zhang Q, Szalay AA.


Vaccinia Virus GLV1h-153 is a Novel Agent for Detection and Treatment/Local Control of Positive Surgical Margins for Breast Cancer
Breast Cancer Res. 2013 Mar 18;15(2):R26.
Gholami S, Chen CH, Belin L, Lou E, Antonacci C, Carew A, Chen NG, De Brot M, Longo V, Zanzonico PB, Szalay AA, Fong Y.


Oncolytic vaccinia therapy of salivary gland carcinoma.
JAMA Otolaryngol Head Neck Surg. 2013 Feb 1;139(2):173-82.
Chernichenko N, Linkov G, Li P, Bakst RL, Chen CH, He S, Yu YA, Chen NG, Szalay AA, Fong Y, Wong RJ.


Imaging of intratumoral inflammation during oncolytic virotherapy of tumors by 19F-magnetic resonance imaging (MRI)
PLoS One. 2013;8(2):e56317.
Weibel S, Basse-Luesebrink TC, Hess M, Hofmann E, Seubert C, Langbein-Laugwitz J, Gentshev I, Sturm VJF, Ye Y, Kampf T, Jakob PM, Szalay AA.


A vaccinia virus encoding the human sodium iodide symporter facilitates long-term image monitoring of virotherapy and targeted radiotherapy of pancreatic cancer.2012.
J Nucl Med. 2012 53:1933-1942
Haddad D, Zanzonic, PB, Carlin S, Chen C H, Chen NG, Zhang Q, Yu Y A, Longo V, Mojica K, Aguilar R J, Szalay AA, Fong Y.


Characterization and evaluation of a new oncolytic Vaccinia Virus strain LIVP6.1.1 for canine cancer therapy.2013.
Bioengineered. 2013;4(2):84-89.
Gentschev I, Patil S, Adelfinger M, Weibel S, Geissinger U, Frentzen A, Chen NG, Yu YA, Zhang Q, Ogilvie G, Szalay AA.


Virotherapy of Canine Tumors with Oncolytic Vaccinia Virus GLV-1h109 Expressing an Anti-VEGF Single-Chain Antibody. 2012.
PLoS One. 2012;7(10):e47472.
Patil SS, Gentschev I, Adelfinger M, Donat U, Hess M, Weibel S, Nolte I, Frentzen A, Szalay AA.


Correlates between host and viral transcriptional program associated with different oncolytic vaccinia virus isolates. 2012
Hum Gene Ther Methods. 2012 Oct 17.
Reinboth J, Ascierto ML, Chen NG, Zhang Q, Yu YA, Aguilar RJ, Carretero R, Worschech A, Zhao Y, Wang E, Marincola FM, Szalay AA.


Preferential Colonization of Metastases by Oncolytic Vaccinia Virus Strain GLV-1h68 in a Human PC-3 Prostate Cancer Model in Nude Mice. 2012.
PLoS One 7(9):e45942.
Donat U, Weibel S, Hess M, Stritzker J, Härtl B, Sturm JB, Chen NG, Gentschev I, Szalay AA


Vaccinia virus-mediated intra-tumoral expression of matrix metalloproteinase 9 enhances oncolysis of PC-3 xenograft tumors. 2012
BMC Cancer. 2012 Aug 23;12(1):366.
Schaefer S, Weibel S, Donat U, Zhang Q, Aguilar RJ, Chen NG, Szalay AA.


Imaging characteristics, tissue distribution, and spread of a novel oncolytic vaccinia virus carrying the human sodium iodide symporter. 2012.
PLoS One. 2012;7(8):e41647. Epub 2012 Aug 17.
Haddad D, Chen CH, Carlin S, Silberhumer G, Chen NG, Zhang Q, Longo V, Carpenter SG, Mittra A, Carson J, Au J, Gonen M, Zanzonico PB, Szalay AA, Fong Y.


Oncolytic vaccinia virus GLV-1h68 strain shows enhanced replication in human breast cancer stem-like cells in comparison to breast cancer cells. 2012.
J Transl Med. 2012 Aug 17;10(1):167.
Wang H, Chen NG, Minev BR, Szalay AA.


Vaccinia Virus GLV-1h153 is Effective in Treating and Preventing Metastatic Triple-Negative Breast Cancer 2012
Ann Surg. 2012 Sep;256(3):437-445.
Gholami S, Chen CH, Lou E, De Brot M, Fujisawa S, Chen NG, Szalay AA, Fong Y


Preclinical evaluation of oncolytic vaccinia virus for therapy of canine soft tissue sarcoma.  2012
PLoS ONE 2012;7(5):e37239.
Gentschev I, Adelfinger M, Josupeit R, Rudolph S, Ehrig K, Weibel S, Chen NG, Yu YA, Zhang Q, Thamm D, Stritzker J, MacNeill A, Szalay AA.


Preferential replication of systemically delivered oncolytic vaccinia virus in focally irradiated glioma xenografts. 2012
Clin Cancer Res. 2012 May 1;18(9):2579-90.
Advani SJ, Buckel L, Chen NG, Scanderbeg DJ, Geissinger U, Zhang Q, Yu YA, Aguilar


Effective oncolytic vaccinia therapy for human sarcomas. 2012
J Surg Res. 2012 Jun 15;175(2):e53-60.
He S, Li P, Chen CH, Bakst RL, Chernichenko N, Yu YA, Chen N, Szalay AA, Yu Z, Fong Y, Wong RJ.


A novel genetically modified oncolytic vaccinia virus in experimental models is effective against a wide range of human cancers. 2012
Ann Surg Oncol. 2012;19:665-674.
Haddad D, Chen N, Zhang Q, Chen CH, Yu YA, Gonzalez L, Aguilar J, Li P, Wong J, Szalay AA, Fong Y.
BACKGROUND: Replication-competent oncolytic viruses have shown great promise as a potential cancer treatment. This study aimed to determine whether a novel vaccinia virus, GLV-1h151, with genetic modifications enhancing cancer specificity and enabling virus detection, is effective against a range of human cancers and is safe when administered in preclinical models.


Functional hyper-IL-6 from vaccinia virus-colonized tumors triggers platelet formation and helps to alleviate toxicity of mitomycin C enhanced virus therapy.  2012
J Transl Med. 2012 Jan 11;10(1):9.
Sturm JB, Hess M, Weibel S, Chen NG, Yu YA, Zhang Q, Donat U, Reiss C, Gambaryan S, Stritzker J, A. A. Szalay AA.


Oncolytic virotherapy in veterinary medicine: current status and future prospects for canine patients. 2012.
Journal of Translational Medicine. 10:3
Sandeep S. Patil, Ivaylo Gentsche v, Ingo Nolte, Gregory Ogilvie, and Aladar A. Szalay


Permissivity of the NCI-60 cancer cell lines to oncolytic Vaccinia Virus GLV-1h68. 2011.
BMC Cancer. Oct 19;11:451.
Ascierto ML, Worschech A, Yu Z, Adams S, Reinboth J, Chen NG, Pos Z, Roychoudhuri R, Di Pasquale G, Bedognetti D, Uccellini L, Rossano F, Ascierto PA, Stroncek DF, Restifo NP, Wang E, Szalay AA, Marincola FM.


Novel therapy for anaplastic thyroid carcinoma cells utilizing an oncolytic vaccinia virus carrying the human sodium iodide symporter. 2011.
Surgery. 150: 1040-7
Sepideh Gholami, Dana Haddad, Chun-Hao Chen, Nanhai G. Chen, Qian Zhang, Pat B. Zanzonico, and Aladar A. Szalay, Yuman Fong


Bacterial glucuronidase as general marker for oncolytic virotherapy or other biological therapies. 2011.
Journal of Translational Medicine. 9:172.
Michael Hess, Jochen Stritzker, Barbara Härtl, Julia B. Sturm, Ivaylo Gentschev and Aladar A. Szalay


Magnetic Resonance Imaging of tumors colonized with bacterial ferritin-expressing Escherichia coli. 2011.
PLoS ONE. Vol. 6:10.
Philip Hill, Jochen Stritzker, Miriam Scadeng, Ulrike Geissinger, Daniel Haddad, Thomas Basse-Lusebrink, Uwe Gbureck, Peter Jakob, Aladar Szalay.


Replication efficiency of oncolytic vaccinia virus in cell cultures prognosticates the virulence and antitumor efficacy in mice. 2011.
Journal of Translational Medicine. 9:164.
Nanhai G. Chen, Yong A. Yu, Qian Zhang and Aladar A. Szalay


Efficient colonization and therapy of human hepatocellular carcinoma (HCC) using the oncolytic vaccinia virus strain GLV-1h68. 2011.
PLoS ONE. Vol. 6:7, e22069.
Ivaylo Gentschev, Meike Müller, Marion Adelfinger, Stephanie Weibel, Friedrich Grummt, Martina Zimmermann, Michael Bitzer, Qian Zhang, Yong A. Yu, Nanhai G. Chen, Jochen Stritzker, Ulrich M. Lauer, Aladar A. Szalay


Insertion of the human sodium iodide symporter to facilitate deep tissue imaging does not alter oncolytic or replication capability of a novel vaccinia virus. 2011.
Journal of Translational Medicine. 9:36.
Dana Haddad, Nanhai G Chen, Qian Zhang, Chun-Hao Chen, Yong A Yu, Lorena Gonzalez, Susanne G Carpenter, Joshua Carson, Joyce Au, Arjun Mittra, Mithat Gonen, Pat B Zanzonico, Yuman Fong and Aladar A Szalay


Vaccinia Virus GLV-1h237 carrying a Walker A motif mutation of mouse Cdc6 protein enhances human breast tumor therapy in mouse xenografts. 2011.
International Journal of Oncology. 38(3):871-8.
Hofmann E, Grummt F, Szalay A.A.


Viral-mediated oncolysis is the most critical factor in the late-phase of the tumor regression process upon vaccinia virus infection. 2011.
BMC Cancer. 11:68
Stephanie Weibel, Viktoria Raab, Yong Yu, Andrea Worschech, Ena Wang, Francesco Marincola, and Aladar Szalay


Oncolytic Virotherapy of Cancer. 2011.
Cancer Management in Man: Chemotherapy, Biological Therapy, Hyperthermia and Supporting Measures, Cancer Growth and Progression. 295-316.
Chen N.G., Szalay A.A.


Oncolytic vaccinia virus: a theranostic agent for cancer. 2010.
Future Virology. November 2010, Vol. 5, No. 6, Pages 763-784.
Chen N.G., Szalay A. A.


Enhanced tumor therapy using vaccinia virus strain GLV-1h68 in combination with a β-galactosidase-activatable prodrug seco-analog of duocarmycin SA. (2011)
Cancer Gene Therapy. 2011;18:42-52.
Seubert CM, Stritzker J, Hess M, Donat U, Sturm JB, Chen N, Hof JM, Krewer B, Tietze LF, Gentschev I, Szalay AA.


Enterobacterial tumor colonization in mice depends on bacterial metabolism and macrophages but is independent of chemotaxis and motility. (2010)
Int J Med Microbiol. 2010;300(7):449-56.
Stritzker J, Weibel S, Seubert C, Götz A, Tresch A, van Rooijen N, Oelschlaeger TA, Hill PJ, Gentschev I, Szalay AA.


Significant growth inhibition of canine mammary carcinoma xenografts following treatment with oncolytic vaccinia virus GLV-1h68. (2010)
Journal of Oncology. 2010:736907, 10.
Gentschev I, Ehrig K, Donat U, Hess M, Rudolph S, Chen N, Yu Y.A., Zhang Q, Bullerdiek J, Nolte I, Stritzker J, Szalay AA.


Regression of human prostate tumors and mestastases in nude mice following treatment with the recombinant oncolytic vaccinia virus GLV-1h68. (2010)
Journal of Biomedicine and Biotechnology. 2010: 489759.
Gentschev I, Donat U, Hofmann E, Weibel S, Adelfinger M, Raab V, Heisig M, Chen N, Yu YA, Stritzker J, Szalay AA.


Myristoylation negative msbB-mutants of probiotic E. coli Nissle 1917 retain tumor specific colonization properties but show less side effects in immunocompetent mice. (2010)
Bioengineered Bugs. 1:2, 139-145:March/April 2010.
Stritzker J, Hill P, Gentschev I, Szalay AA.


The highly attenuated oncolytic recombinant vaccinia virus GLV-1h68: Comparative genomic features and the contribution of F14.5L inactivation (2009)
Mol Genet Genomics. 2009 Oct;282(4):417-35
Zhang Q, Liang C, Yu YA, Chen N, Dandekar T, Szalay AA.


Oncolytic vaccinia viral therapy of squamous cell carcinoma (2009)
Molecular Cancer.
Yu Z, Li S, Brader P, Chen N, Yu YA, Zhang Q, Szalay AA, Fong Y, Wong RJ.


Anti-VEGF single chain antibody GLAF-1 encoded by oncolytic vaccinia virus significantly enhances therapy in colonized tumor xenografts (2009)
Frentzen A, Yu YA, Chen N, Zhang Q, Weibel S, Raab V, Szalay AA.


Imaging a Genetically Engineered Oncolytic Vaccinia Virus (GLV-1h99) Using a Human Norepinephrine transporter (hNET) Report Gene (2009)
Clinical Cancer Research. 15(11):3791-3801.
Brader P, Kelly K, Chen N, Yu YA, Zhang Q, Zanzonico P, Burnazi EM, Ghani ER, Serganova I, Hricak H, Szalay AA, Fong Y, Blasberg R.


Systemic treatment of xenografts with vaccinia virus GLV-1h68 reveals the immunologic facet of oncolytic therapy (2009)
BMC Genomics.
Andrea Worschech, Nanhai Chen, Yong A Yu, Qian Zhang, Zoltan Pos, Stephanie Weibel, Viktoria Raab, Marianna Sabatino, Alessandro Monaco, Hui Liu, Vladia Monsurró, R. Mark Buller, David F Stroncek, Ena Wang, Aladar A Szalay, Francesco M Marincola.


The immunologic aspects of poxvirus oncolytic therapy. (2009)
Cancer Immunology, Immunotherapy. 58:1355-1362.
A. Worschech, D. Haddad, DF. Stroncek, E. Wang, F. M. Marincola, A. A. Szalay.


A novel recombinant vaccinia virus expressing the human norepinephrine transporter retains oncolytic potential and facilitates deep tissue imaging. (2009)
Molecular Medicine. 15 (5-6) 144-151.
Nanhai Chen, Qian Zhang, Yong A. Yu, Peter Brader, Inna Serganova, Ronald Blasberg, Yuman Fong, and Aladar A. Szalay.


Real-time intraoperative detection of melanoma lymph node metastases using recombinant vaccinia virus GLV-1h68 in an immunocompetent animal model. (2009)
International Journal of Cancer. 124:911-918.
Kelly K, Woo Y, Brader P, Li S, Chen N, Yu YA, Szalay AA, Fong Y.


Regression of human pancreatic tumor xenografts in mice after a single systemic injection of recombinant vaccinia virus GLV-1h68. (2009)
Molecular Cancer Therapeutics. 8:141-151.
Yu YA, Galanis C, Woo Y, Chen N, Zhang Q, Fong Y, Szalay AA.


Use of an oncolytic vaccinia virus for treatment of canine breast cancer in nude mice: preclinical development of a therapeutic agent. (2008)
Cancer Gene Therapy. 16(4):320-8.
Gentschev I, Stritzker J, Hofmann E, Weibel S, Yu YA, Chen N, Zhang Q, Bullerdiek J, Nolte I, Szalay AA.


Oncolytic Vaccinia Therapy for Anaplastic Thyroid Cancer In Vivo. (2008)
Journal of Clinical Endocrinology and Metabolism. 93(11):4403-4407.
Lin SF, Price DL, Chen CH, Brader P, Li S, Gonzalez L, Zhang Q, Yu YA, Chen N, Szalay AA, Fong Y, Wong RJ.


Novel oncolytic agent, GLV-1h68, is effective against malignant pleural mesothelioma. (2008)
Human Gene Therapy. 19:774-782.
Kelly K, Woo Y, Brader P, Yu Z, Riedl C, Lin S, Chen N, Yu YA, Rusch VW, Szalay AA, Fong Y.


Colonization of experimental murine breast tumors by E. coli K-12 significantly alters the tumor microenvironment. (2008)
Cellular Microbiology. 10(6), 1235-1248.
Weibel S, Stritzker J, Eck M, Goebel W, Szalay AA.


Establishment and characterization of conditions required for tumor colonization by intravenously delivered bacteria. (2008)
Biotechnology and Bioengineering. 100(3), 567-578.
Yu YA, Zhang Q, Szalay AA.


Prodrug converting enzyme gene delivery by L. monocytogenes. (2008)
BMC Cancer. 8:94.
Stritzker J, Pilgrim S, Szalay AA, Goebel W.


Escherichia coli Nissle 1917 facilitates tumor detection by positron emission tomography and optical imaging. (2008)
Clinical Cancer Research. 14(8), 2295-2302.
Brader P, Stritzker J, Riedl CC, Zanzonico P, Cai S, Burnazi EM, Ghani ER, Hricak H, Szalay AA, Fong Y, Blasberg R.


Signatures Associated with Rejection or Recurrence in HER-2/neu-Positive Mammary Tumors.
Cancer Research. 68(7), 2436-46.
Worschech A, Kmieciak M, Keeler JM, Bear HD, Szalay AA, Wang E, Marincola FM, Manjili MH


Treatment of anaplastic thyroid carcinoma in vitro with a mutant vaccinia virus. (2007)
Surgery. 14 (6): 976-983.
Shu-Fu L, Yu Z, Riedl C, Woo Y, Zhang Q, Yu YA, Timiryasova T, Chen N, Shah JP, Szalay AA, Fong Y, Wong RJ


E. coli Nissle 1917: Vom Kriegsveteran weiterentwickelt zum aktiven Kämpfer gegen Tumoren? [E. coli Nissle 1917: From War Veteran to Genetically-Directed Tumor Fighter.] (2007)
GenomXpress, 4.07, 12-14. Review.
Stritzker J, Szalay AA.


Eradication of Solid Human Breast Tumors in Nude Mice with an Intravenously Injected Light-Emitting Oncolytic Vaccinia Virus. (2007)
Cancer Research. 67 (20), 10038-46.
Zhang Q, Yu YA, Wang E, Chen N, Danner RL, Munson PJ, Marincola FM, Szalay AA.


Proceedings of the 14th International Symposium on Bioluminescence & Chemiluminescence: Chemistry, Biology and Applications. (2007)
World Scientific: Singapore.
Szalay AA, Kricka LJ, Stanley PE, Hill JP. eds.


Real-time monitoring of vaccinia virus infection in cultured cells and in living mice using light-emitting proteins. (2007)
In: Proceedings of the 14th International Symposium on Bioluminescence & Chemiluminescence: Chemistry, Biology and Applications.
World Scientific: Singapore, 2007: 181-184.
Chen N, Yu YA, Zhang Q, Raab V, Szalay AA.


Four-color labeling of cell culture and tumors of live mice upon infection with: GFP-Ruc and RFP-CBG99 expressing Vaccinia virus strains. (2007)
In: Proceedings of the 14th International Symposium on Bioluminescence & Chemiluminescence: Chemistry, Biology and Applications.
World Scientific: Singapore, 2007: 197-200.
Raab V, Horbaschek C, Chen N, Zhang Q, Yu YA, Seubert C, Geissinger U, Worschech A, Tietze CJ, Zellner E, Le TH, Grummt F, Stritzker J, Szalay AA.


Evaluation of an in vivo gene induction system in infected tumor-bearing mice. (2007)
In: Proceedings of the 14th International Symposium on Bioluminescence & Chemiluminescence: Chemistry, Biology and Applications.
World Scientific: Singapore, 2007: 205-208.
Stritzker J, Weibel S, Hill PJ, Szalay AA.


Examinations of bacterium-mediated detection of tumors in mice models. (2007)
In: Proceedings of the 14th International Symposium on Bioluminescence & Chemiluminescence: Chemistry, Biology and Applications.
World Scientific: Singapore, 2007: 209-212.
Yu YA, Szalay AA.


Tumor-specific colonization, tissue distribution, and gene induction by probiotic E. coli Nissle 1917 in live mice. (2007)
International Journal of Medical Microbiology. 297(3):151-62.
Stritzker J, Weibel S, Hill PJ, Oelschlaeger TA, Goebel W, Szalay AA.


Visualization of tumors and metastases in live animals with bacteria and vaccinia virus encoding light-emitting proteins. (2004)
Nature Biotechnology. 22, 313-320.
Yu YA, Shabahang S, Timiryasova T, Zhang Q, Beltz R, Gentschev I, Goebel W, Szalay AA.


Optical imaging: bacteria, viruses, and mammalian cells encoding light-emitting proteins reveal the locations of primary tumors and metastases in animals. (2003)
Analytical and Bioanalytical Chemistry. 377, 964-972.
Yu YA, Timiryasova T, Zhang Q, Beltz R, Szalay AA.


Expanded Access Policy

Outside of our clinical trials, we may provide physician-requested expanded access to its investigational products under limited situations. The request for access to a Genelux investigational drug will be considered only if all the following criteria are met.


  • The patient has a serious or life-threatening disease or condition with no comparable or satisfactory alternative therapies
  • The patient is not eligible for or unable to participate in a clinical trial
  • The investigational drug is currently in clinical development with sufficient evidence of safety and effectiveness for patient’s specific condition
  • A benefit-risk analysis suggests that the benefit from using of the investigational drug outweighs the known or anticipated risks based on evolving clinical data
  • We have adequate supply of investigational drug


If the investigational drug is approved by a regulatory agency for commercial use, including provisional approval, existing expanded access programs will be phased out or modified accordingly.


Patients interested in seeking an expanded access to a Genelux investigative drug should talk to their physician. All requests must be made by the patient’s treating physician by email at We will, in general, acknowledge receipt of a request for expanded access within five business days. We may ask for more detailed information to fully evaluate a request.


The request for access to an investigative drug can only be considered if the requesting physician agrees to obtain applicable regulatory and ethics committee approvals. We may deny access if the treating physician cannot guarantee an appropriate storage and handling of the investigative drug, which typically requires a temperature controlled deep freezer and follows Biosafety Level 2 safety procedures and precautions. The treating physician must agree to comply with regulatory obligations, including safety monitoring and reporting.


For more information on expanded access from the FDA, click here.