Clinical Publications

Clinical Publications

A phase 1b study of intraperitoneal oncolytic viral immunotherapy
in platinum-resistant or refractory ovarian cancer
Gynecologic Oncology 2021, Volume 163, Issue 3, P481-489.
Madhavi Manyam, Amanda J. Stephens, Jessica A. Kennard, Jane LeBlanc, Sarfraz Ahmad, James E. Kendrick, Robert W. Holloway

>Abstract.

 

Phase 2 Trial of Oncolytic Vaccinia Virus Primed Immunochemotherapy in Platinum-Resistant/Refractory Ovarian Cancer (PRROC) (NCT02759588)
European Society for Medical Oncology (ESMO) Virtual Congress 2020
Robert W. Holloway, Alberto A. Mendivil, James E. Kendrick, Lisa N. Abaid, John V. Brown, Christine K. Fitzsimmons, Jessica A. Kennard, Monica King, Jane LeBlanc, Katrina Lopez, Madhavi Manyam, Nathalie D. McKenzie, Kristina M. Mori, Amanda J. Stephens, Sarfraz Ahmad

>Poster.

 

Phase 2 Trial of Oncolytic Vaccinia Virus Primed Immunochemotherapy in Platinum-Resistant/Refractory Ovarian Cancer (PRROC) (NCT02759588)
Annals of Oncology (2020) 31 (suppl_4): S551-S589.
Robert W. Holloway, Alberto A. Mendivil, James E. Kendrick, Lisa N. Abaid, John V. Brown, Christine K. Fitzsimmons, Jessica A. Kennard, Monica King, Jane LeBlanc, Katrina Lopez, Madhavi Manyam, Nathalie D. McKenzie, Kristina M. Mori, Amanda J. Stephens, Sarfraz Ahmad

>Abstract.

 

Oncolytic Vaccinia (Olvi-Vec) Primed Immunochemotherapy in Platinum-Resistant/Refractory Ovarian Cancer
Global Annual Meeting of the International Gynecologic Cancer Society (IGCS) 2020
Robert W. Holloway, Alberto A. Mendivil, James E. Kendrick, Lisa N. Abaid, John V. Brown, Christine K. Fitzsimmons, Jessica A. Kennard, Monica King, Jane LeBlanc, Katrina Lopez, Madhavi Manyam, Nathalie D. McKenzie, Kristina M. Mori, Amanda J. Stephens, Sarfraz Ahmad

>Watch Oral Plenary Presentation. (video)

 

Oncolytic Vaccinia (Olvi-Vec) Primed Immunochemotherapy in Platinum-Resistant/Refractory Ovarian Cancer
Global Annual Meeting of the International Gynecologic Cancer Society (IGCS) 2020
Robert W. Holloway, Alberto A. Mendivil, James E. Kendrick, Lisa N. Abaid, John V. Brown, Christine K. Fitzsimmons, Jessica A. Kennard, Monica King, Jane LeBlanc, Katrina Lopez, Madhavi Manyam, Nathalie D. McKenzie, Kristina M. Mori, Amanda J. Stephens, Sarfraz Ahmad

>Abstract 12. (page 23)

 

Phase 2 VIRO-15 Trial of OlvimulogeneNanivacirepvec (Olvi-Vec)-Primed Immunochemotherapy in Platinum-Resistant/Refractory Ovarian Cancer
Society Of Gynecologic Oncology 2020 Annual Meeting
Robert W. Holloway, Alberto A. Mendivil, James E. Kendrick, Lisa N. Abaid, John V. Brown, Christine K. Fitzsimmons, Jessica A. Kennard, Monica King, Jane LeBlanc, Katrina Lopez, Madhavi Manyam, Nathalie D. McKenzie, Kristina M. Mori, Jamie L. Smith, Amanda J. Stephens, Sarfraz Ahmad

>Abstract.

 

Pronounced clinical response following the oncolytic vaccinia virus GL-ONC1 and chemotherapy in a heavily pretreated ovarian cancer patient
Anti-Cancer Drugs 2019, 30:1064–1066
Kristina M. Mori, Peter D. Giuliano, Katrina L. Lopez, Monica M. King, Randy Bohart and Bram H. Goldstein

>Abstract.

 

Factors associated with extended survival for patients with platinum-resistant ovarian cancer treated with modified vaccinia oncolytic virotherapy
J Clin Oncol 37, 2019 (suppl; abstr e17070)
Madhavi Manyam, Amanda J. Stephens, Jessica A. Kennard, Christine K. Fitzsimmons, James Erasmus Kendrick, Nathalie Dauphin McKenzie, Jane LeBlanc, Jamie L. Smith, Sarfraz Ahmad, Robert W. Holloway

>Abstract.

 

Phase I study of oncolytic vaccinia virus GL-ONC1 in patients with peritoneal carcinomatosis
Clin Cancer Res 2018 Sep 15;24(18):4388-4398.
Ulrich M. Lauer, Martina Schell, Julia Beil, Susanne Berchtold, Ursula Koppenhöfer, Jörg Glatzle, Alfred Königsrainer, Robert Möhle, Dominik Nann, Falko Fend, Christina Pfannenberg, Michael Bitzer, Nisar P. Malek

>Abstract.

 

Phase 1b Study of Oncolytic Vaccinia Virus GL-ONC1 in recurrent ovarian cancer [Poster]
American Society of Clinical Oncology 2018 Annual Meeting
Robert W Holloway, James E Kendrick, Amanda J Stephens, Jessica A Kennard, Jeremy Burt, Jane LeBlanc, Karen Sellers, Jamie Smith, and Susan Coakley

>Poster.

 

Phase 1b study of oncolytic vaccinia virus GL-ONC1 in recurrent ovarian cancer
Journal of Clinical Oncology 36, no.15_suppl (May 20, 2018) 5577-5577
Robert W Holloway, James E Kendrick, Amanda J Stephens, Jessica A Kennard, Jeremy Burt, Jane LeBlanc, Karen Sellers, Jamie Smith, and Susan Coakley

>Abstract.

 

Phase I Trial of Intravenous Oncolytic Vaccinia Virus (GL-ONC1) with Cisplatin and Radiotherapy in Patients with Locoregionally Advanced Head and Neck Carcinoma
Clin Cancer Res; 23(19) October 1, 2017
Loren K. Mell, Kevin T. Brumund, Gregory A. Daniels, Sunil J. Advani,Kaveh Zakeri, Mary E. Wright, Sara-Jane Onyeama, Robert A. Weisman,Parag R. Sanghvi, Peter J. Martin, and Aladar A. Szalay

>Abstract.

 

Phase I Trial of Intravenously Delivered Attenuated Vaccinia Virus (GL-ONC1) with Chemoradiotherapy for Locoregionally Advanced Head/Neck Cancer [Poster]
American Society Of Clinical Oncology 2015 Annual Meeting
Loren K. Mell, Tony Yu, Kevin T. Brumund, Gregory A. Daniels, Sunil J. Advani, Parag Sanghvi, Mary E Wright, Sara-Jane Onyeama, Anu Põld, Terry Chamberlin, Peter Martin, Robert Weisman, Aladar A. Szalay

>Poster.

 

Phase I study of intra-pleural administration of GL-ONC1, an oncolytic vaccinia virus, in patients with malignant pleural effusion [Poster]
American Society Of Clinical Oncology 2015 Annual Meeting
L.M. Krug, M.G. Zauderer, P. Adusumilli, E. McGee, K. Sepkowitz, M. Klang, Y.A. Yu, P. Scigalla, V.A. Rusch

>Poster.

 

Phase I trial of intravenous attenuated vaccinia virus (GL-ONC1) with concurrent chemoradiotherapy (CRT) for locoregionally advanced head and neck carcinoma
Journal of Clinical Oncology 33, no.15_suppl (May 20, 2015) 6026-6026
Loren K. Mell , Yong A. Yu , Kevin T. Brumund , Gregory A. Daniels , Sunil J. Advani , Robert A. WeismanParag R. Sanghvi , Peter J. Martin , Mary E. Wright , Sara-Jane Onyeama , Qian Zhang , Anu Pold , Terry Chamberlin , Alexa Frentzen , Aladar A Szalay

>Abstract.

 

Phase I study of intra-pleural administration of GL-ONC1, an oncolytic vaccinia virus, in patients with malignant pleural effusion
Journal of Clinical Oncology 33, no.15_suppl (May 20, 2015) 7559-7559
Lee M. Krug , Marjorie Glass Zauderer , Prasad S. Adusumili , Erin McGee , Kent Sepkowitz , Mark KlangYong A. Yu , Paul Scigalla , Valerie W. Rusch

>Abstract.

 

Phase I Trial of Intravenously Delivered Attenuated Vaccinia (GL-ONC1) with Chemoradiotherapy for Locoregionally Advanced Head/Neck Cancer [Poster]
American Society Of Clinical Oncology 2014 Annual Meeting
Loren K. Mell, Tony Yu, Kevin T. Brumund, Gregory A. Daniels, Sunil J. Advani, Parag Sanghvi, Sara-Jane Onyeama, Peter Martin, Robert Weisman, AladarA. Szalay

>Poster.

 

Phase 1 Trial of Attenuated Vaccinia Virus (GL-ONC1) Delivered Intravenously With Concurrent Cisplatin and Radiation Therapy in Patients With Locoregionally Advanced Head-and-Neck Carcinoma Definitive Management of Head-and-Neck Squamous Cell Carcinoma
International Journal of Radiation Oncology 88(2)2014:477-8
L.K. Mell, Y.A. Yu, K.T. Brumund, S.J. Advani, S. Onyeama, G.A. Daniels, R.A. Weisman, P. Martin, A.A. Szalay 

>Abstract.

 

Results on the First Study on Intraperitoneal Virotherapy Employing a Recombinant Vaccinia Virus Genetically Engineered to Selectively Replicate in and Destroy Cancer Cells
Zeitschrift für Gastroenterologie 52(08) August 2014
UM Lauer, J Beil, S Berchtold, M Zimmermann, U Koppenhöfer, M Bitzer, NP Malek, J Glatzle, A Königsrainer, R Möhle, F Fend, C Pfannenberg, T Auth, T Yu, AA Szalay

>Abstract.

 

Tracking of tumor cell colonization, in-patient replication, and oncolysis by GL-ONC1 employed in a phase I/II virotherapy study on patients with peritoneal carcinomatosis [Poster]
Oncolytic Virus Conference Oxford 2014
Ulrich M Lauer, Julia Beil, Susanne Berchtold, Martina Zimmermann, Ursula Koppenhoefer, Michael Bitzer, Nisar P Malek, Joerg Glatzle, Alfred Koenigsrainer, Robert Moehle, Falko Fend, Christina Pfannenberg, Tanja Auth, Tony Yu, Aladar A Szalay

>Poster.

 

Tracking of tumor cell colonization, in-patient replication, and oncolysis by GL-ONC1 employed in a phase I/II virotherapy study on patients with peritoneal carcinomatosis
Oncolytic Virus Conference Oxford 2014
Ulrich M Lauer, Julia Beil, Susanne Berchtold, Martina Zimmermann, Ursula Koppenhoefer, Michael Bitzer, Nisar P Malek, Joerg Glatzle, Alfred Koenigsrainer, Robert Moehle, Falko Fend, Christina Pfannenberg, Tanja Auth, Tony Yu, Aladar A Szalay

>Abstract.

 

Validation of Biomarkers of Intravenously Administered Oncolytic Vaccinia Virus in a Phase I Trial [Poster]
Oncolytic Virus Conference Quebec 2013
Mansfield D, Yu T, Chen N, Stritzker J, Szalay AA, Harrington KJ

>Poster.

 

Phase I/II clinical trial of a genetically modified and oncolytic vaccinia virus GL-ONC1 in patients with unresactable, chemotherapy-resistant peritoneal carcinomatosis
Journal of Clinical Oncology 31(15_suppl):3098-3098 May 2013
Ulrich Lauer, Martina Zimmermann, Julia Sturm, Ursula Koppenhoefer, Michael Bitzer, Nisar P Malek, JoergGlatzle, Alfred Koenigsrainer, Robert Moehle, Falko Fend, Christina Pfannenberg, Tanja Auth, Tony Yu, Aladar A Szalay

>Abstract.

 

Phase I/II clinical trial of a genetically modified and oncolytic vaccinia virus GL-ONC1 in patients with unresactable, chemotherapy-resistant peritoneal carcinomatosis [Poster]
American Society of Clinical Oncology 2013 Annual Meeting
Ulrich Lauer, Martina Zimmermann, Julia Sturm, Ursula Koppenhoefer, Michael Bitzer, Nisar P Malek, JoergGlatzle, Alfred Koenigsrainer, Robert Moehle, Falko Fend, Christina Pfannenberg, Tanja Auth, Tony Yu, Aladar A Szalay

>Poster.

 

Phase I Clinical Trial of a Genetically Modified and Oncolytic Vaccinia Virus GL-ONC1 with Green Fluorescent Protein Imaging
American Society Of Clinical Oncology 2013 Annual Meeting
H. Khan, A. Young, J. Mateo, N. Tunariu, T. A. Yap, D.Tan, D. Mansfield, M. Wong, R. Riisnaes, K. J. Harrington, H.Pandha, J. S. deBono

>Abstract.

 

Phase I Clinical Trial of a Genetically Modified and Oncolytic Vaccinia Virus GL-ONC1 with Green Fluorescent Protein Imaging
Journal of Clinical Oncology 30, no. 15_suppl (May, 2012):2530-2530

>Abstract.

 

A Phase I clinical trial of a genetically modified and imageable oncolytic vaccinia virus GL-ONC1 with clinical green fluorescent protein (GFP) imaging [Poster]
American Society Of Clinical Oncology 2011 Annual Meeting
Joanna Vitfell-Pedersen, Elena Karapanagiotou, Andrea Biondo, Martina Puglisi, Katie Denholm, Nina Tunariu, Salem Sassi, David Mansfield, Timothy Yap, Johann De-Bono and Kevin Harrington

>Poster.

 

Phase I Clinical Trial of a Genetically Modified and Oncolytic Vaccinia Virus GL-ONC1 with Green Fluorescent Protein Imaging
Journal of Clinical Oncology 29, no.15_suppl (May 20, 2011) 2577-2577
J. V. Pedersen , E. M. Karapanagiotou , A. Biondo , N. Tunariu , M. Puglisi , K. A. DenholmS. Sassi , D. Mansfield , T. A. Yap , J. S. De Bono , K. J. Harrington

>Abstract.

 

Phase I Clinical Trial of a Genetically Modified and Oncolytic Vaccinia Virus GL-ONC1 with Green Fluorescent Protein Imaging
2011 NCRI Conference
Corral, A. Biondo, J. V. Pedersen, S. Alam, E. M. Karapanagiotou, N. Tunariu, K. Shah, N. Simoes, D. Goswani, E.D. Mansfield, S. Sassi, T. A. Yap, J. S. de Bono, K. J. Harrington

>Abstract.

 

Preliminary results of a Phase 1 study of intravenous administration of GL-ONC1 Vaccinia virus in patients with advanced solid cancer with real time imaging. [Poster]
European Society of Medical Oncology 2010
Joanna Vitfell Pedersen, Elena Karapanagiotou, Salma Alam, Martina Puglisi, Lauren Britton, Salem Sassi, David Mansfield, Timothy Yap, Johann De-Bono and Kevin Harrington

>Poster.

 

Preliminary results of a Phase 1 study of intravenous administration of GL-ONC1 Vaccinia virus in patients with advanced solid cancer with real time imaging. [Poster]
European Organisation for Research and Treatment of Cancer 2011
Joanna Vitfell Pedersen, Elena Karapanagiotou, Salma Alam, Martina Puglisi, Lauren Britton, Salem Sassi, David Mansfield, Timothy Yap, Johann De-Bono and Kevin Harrington

>Poster.

 

Expanded Access Policy

Genelux Corporation is committed to developing safe and effective next-generation immunotherapies for patients suffering from aggressive and/or difficult-to-treat solid tumor types. Our goal is to ensure access to our investigational therapies at the appropriate time and in a clinically appropriate manner for patients.

Outside of our clinical trials, we may provide physician-requested expanded access to its investigational products under limited situations. This is initiated when the primary purpose is to diagnose, prevent, or treat a serious condition in a patient, which is different from a clinical trial where more comprehensive safety and efficacy data are collected. At Genelux, we recognize and understand the need for an early/expanded access policy for patients who have serious or immediately life-threatening disease and have limited available treatment options.

The request for access to a Genelux investigational drug will be considered only if the patient is an eligible patient, meaning:

  • The patient has a serious or life-threatening disease or condition with no comparable or satisfactory alternative therapies; and
  • The patient is not eligible for or unable to participate in a clinical trial

In addition, prior to setting up an expanded access program or granting a request from an eligible patient’s physician, Genelux will consider whether:

  • The investigational drug is currently in clinical development with sufficient evidence of safety and effectiveness for patient’s specific condition;
  • Providing the investigational therapy as part of an expanded access program will interfere with clinical trials that could support the investigational therapy’s development or marketing approval for the treatment indication; and
  • We have adequate supply of investigational drug.

At this time, based on these factors, Genelux believes that participation in one of our clinical trials is the only appropriate way to access our investigational therapies.

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 EAP@genelux.com. 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.