Trials 16
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT01380600 | Sep 2010 → Oct 2012 | colorectal carcinoma | Jennerex Biotherapeutics | Completed | No outcome recorded |
| Phase 1 | NCT01169584 | Aug 2010 → Mar 2012 | Ewing sarcoma, Wilms tumor, lymphoma, neuroblastoma +1 | Jennerex Biotherapeutics | Completed | No outcome recorded |
| Phase 1 | NCT01469611 | Jul 2010 → Oct 2012 | colorectal carcinoma | Samsung Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT00629759 | Jan 2006 → Jul 2007 | liver cancer | Jennerex Biotherapeutics | Completed | No outcome recorded |
| Phase 1/25 trials | ||||||
| Phase 1/2 | NCT03294083 | Jun 2018 → Feb 2023 | renal cell carcinoma | SillaJen, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT03071094 | Jul 2017 → Sep 2020 | hepatocellular carcinoma | Transgene | Terminated | No outcome recorded |
| Phase 1/2 | NCT02630368 | Sep 2015 → May 2023 | breast cancer, soft tissue sarcoma | Institut Bergonié | Unknown | No outcome recorded |
| Phase 1/2 | NCT01394939 | Jan 2012 → Jun 2015 | colorectal carcinoma | Jennerex Biotherapeutics | Completed | No outcome recorded |
| Phase 1/2 | NCT00429312 | Mar 2007 → Feb 2008 | melanoma | Jennerex Biotherapeutics | Completed | No outcome recorded |
| Phase 26 trials · 1 missed | ||||||
| Phase 2 | NCT02017678 | Jan 2014 → Jan 2015 | ovarian cancer | Andrea McCart | Withdrawn | No outcome recorded |
| Phase 2 | NCT01636284 | Jun 2012 → Jun 2013 | hepatocellular carcinoma | Jennerex Biotherapeutics | Completed | No outcome recorded |
| Phase 2 | NCT01387555 | Oct 2011 → Oct 2013 | hepatocellular carcinoma | Jennerex Biotherapeutics | Completed | Missed primary |
| Phase 2 | NCT01329809 | Oct 2011 → Jan 2012 | colorectal carcinoma | Jennerex Biotherapeutics | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT01171651 | May 2009 → Sep 2012 | hepatocellular carcinoma | Jennerex Biotherapeutics | Completed | No outcome recorded |
| Phase 2 | NCT00554372 | Aug 2008 → Dec 2011 | hepatocellular carcinoma | Jennerex Biotherapeutics | Completed | No outcome recorded |
| Phase 31 trial · 1 missed | ||||||
| Phase 3 | NCT02562755 | Oct 2015 → Jul 2020 | hepatocellular carcinoma | SillaJen, Inc. | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2019-08-02 | Transgene | Results Transgene Provides Update on PHOCUS Study of Pexa-Vec in Liver Cancer Following Planned Interim Futility Analysis transgene.com ↗
Sillajen has informed Transgene of the IDMC’s recommendation to stop enrolment in the study, as the study is unlikely to meet its primary objective by the time of the final analysis. |
| 2017-09-07 | Transgene | Results Transgene and Institut Bergonié Present a Poster on the METROmaJX Trial (Oncolytic Virus Pexa-Vec + Metronomic Cyclophosphamide) at ESMO 2017 Congress transgene.com ↗
These Phase 1 trial results showed that the regimen associating intravenous infusion of Pexa-Vec (JX -594) with low -dose cyclophosphamide was well -tolerated with no dose limiting toxicity in patients with solid tumors. |
All press releases naming this drug 5 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 18 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | JX 594 | “This study is to determine how effectively JX-594 (Pexa-Vec) will prolong life in patients with advanced Hepatocellular Carcinoma (HCC)” NCT01636284 ↗ |
| Known as | Pexa-Vec | “This is a Phase Ib, open-label, dose-escalation study designed to evaluate the safety and tolerability of Pexa-Vec (JX-594), a vaccinia GM-CSF/thymidine kinase-deactivated...” NCT01380600 ↗8“The purpose of this study is to evaluate the safety, tolerability, and efficacy of JX-594 (Pexa-Vec) administered intravenously either alone or in combination with Irinotecan...” NCT01394939 ↗ “The primary purpose of this study is to determine the maximum tolerable dose (MTD) and/or the maximum feasible dose (MFD), as well as to evaluate the safety of JX-594...” NCT00629759 ↗ “The purpose of this research study is to find out whether JX-594 (Pexa-Vec) is safe and effective for treating surgically unresectable malignant melanoma.” NCT00429312 ↗ “Patients will receive either an intravenous infusion or an intratumoral injection of JX-594 (Pexa-Vec) directly into one liver lesions at Day 1.” NCT01329809 ↗ “This study is to determine how effectively JX-594 (Pexa-Vec) will prolong life in patients with advanced Hepatocellular Carcinoma (HCC)” NCT01636284 ↗ “JX-594 (Pexa-Vec) is an oncolytic and immunotherapeutic vaccinia virus.” PMID 23396206 ↗ Feb 2013 “Pexastimogene Devacirepvec (Pexa Vec)” NCT02562755 ↗ “Pexastimogene Devacirepvec (Pexa Vec)” NCT03071094 ↗ |
| Known as | pexastimogene devacirepvec | “Pexastimogene devacirepvec (Pexa-Vec) is a vaccinia virus-based oncolytic immunotherapy designed to preferentially replicate in and destroy tumor cells while stimulating...” PMID 31413923 ↗ Jun 2019 |
| Known as | RAC VAC GM-CSF | “JX-594: Recombinant Vaccinia Granulocyte-Macrophage Colony-Stimulating Factor (RAC VAC GM-CSF)” NCT01394939 ↗3“Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)” NCT01380600 ↗ “Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)” NCT01169584 ↗ “Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)” NCT01329809 ↗ |
| Known as | Recombinant Vaccinia GM-CSF | “Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)” NCT01169584 ↗1“Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)” NCT01380600 ↗ |
| Action | Deplete | “designed to selectively replicate in and destroy cancer cells” PMID 18495536 ↗ May 2008 |
| Modality | Other / unclassified | “recombinant vaccinia virus” NCT01169584 ↗ |
| Route | Other | “Intratumoral injection(s) of Recombinant Vaccinia GM-CSF” NCT00429312 ↗ |
| Target | EGFR | “it is speculated that JX-594 replication targets the EGFR pathway” NCT00429312 ↗ |