Trial Outcomes & Findings for A Study of Pexa-Vec (JX-594) Prior to Sorafenib to Treat Unresectable Primary Hepatocellular Carcinoma (NCT NCT01171651)

Last Updated: 2026-07-14

Results Overview

Safety and toxicity will be determined by the incidence of treatment-related Grade 3 and Grade 4 AEs and treatment-related SAEs. Adverse events will be collected and assessed through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

25 participants

Primary outcome timeframe

Safety evaluations through 28 days after last dose of JX-594

Results posted on

2026-07-14

Participant Flow

Patients with advanced, unresectable primary hepatocellular carcinoma (HCC) were recruited from two medical centers in the Republic of Korea: Pusan National University Yangsan Hospital and Pusan National University Hospital.

Participant milestones

Participant milestones
Measure	JX-594 Followed by Sorafenib 1e9 pfu (plaque-forming units) total JX-594 dose on each of up to four (4) JX-594 treatment days. Sorafenib is initiated after 3 JX-594 treatments and briefly interrupted if an optional 4th JX-594 treatment is given.
Overall Study STARTED	25
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	25

Reasons for withdrawal

Reasons for withdrawal
Measure	JX-594 Followed by Sorafenib 1e9 pfu (plaque-forming units) total JX-594 dose on each of up to four (4) JX-594 treatment days. Sorafenib is initiated after 3 JX-594 treatments and briefly interrupted if an optional 4th JX-594 treatment is given.
Overall Study Death	12
Overall Study Physician Decision	10
Overall Study Withdrawal by Subject	1
Overall Study Started Other Anti-cancer Therapy	2

Baseline Characteristics

A Study of Pexa-Vec (JX-594) Prior to Sorafenib to Treat Unresectable Primary Hepatocellular Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	JX-594 Followed by Sorafenib n=25 Participants 1e9 pfu (plaque-forming units) total JX-594 dose on each of up to four (4) JX-594 treatment days. Sorafenib is initiated after 3 JX-594 treatments and briefly interrupted if an optional 4th JX-594 treatment is given.
Age, Continuous	54.9 Years STANDARD_DEVIATION 10.49 • n=9 Participants
Sex: Female, Male Female	3 Participants n=9 Participants
Sex: Female, Male Male	22 Participants n=9 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants
Race (NIH/OMB) Asian	25 Participants n=9 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants
Race (NIH/OMB) Black or African American	0 Participants n=9 Participants
Race (NIH/OMB) White	0 Participants n=9 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=9 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=9 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants
Region of Enrollment South Korea	25 Participants n=9 Participants
Karnofsky Performance Status (KPS) Score 80	2 Participants n=9 Participants
Karnofsky Performance Status (KPS) Score 90	20 Participants n=9 Participants
Karnofsky Performance Status (KPS) Score 100	3 Participants n=9 Participants
Child Pugh Score Class A (Score 5-6)	24 Participants n=9 Participants
Child Pugh Score Class B (Score 7-9)	1 Participants n=9 Participants
Hepatocellular Carcinoma (HCC) stage Stage 1	4 Participants n=9 Participants
Hepatocellular Carcinoma (HCC) stage Stage 2	13 Participants n=9 Participants
Hepatocellular Carcinoma (HCC) stage Stage 3	7 Participants n=9 Participants
Hepatocellular Carcinoma (HCC) stage Stage 4	1 Participants n=9 Participants

PRIMARY outcome

Timeframe: Safety evaluations through 28 days after last dose of JX-594

Outcome measures

Outcome measures
Measure	JX-594 Followed by Sorafenib n=25 Participants 1e9 pfu (plaque-forming units) total JX-594 dose on each of up to four (4) JX-594 treatment days. Sorafenib is initiated after 3 JX-594 treatments and briefly interrupted if an optional 4th JX-594 treatment is given.
Number of Participants With Treatment-Related Grade 3 and Grade 4 Adverse Events (AEs) and Serious Adverse Events (SAEs)	25 Participants

SECONDARY outcome

Timeframe: 12 weeks from first JX-594 dose

Disease Control Rate (DCR) is defined as the percentage of participants achieving a confirmed complete response (CR), partial response (PR), or stable disease (SD), with tumor responses assessed based on modified RECIST (mRECIST 1.0) and/or Choi criteria. Per mRECIST 1.0 for target tumors, CR indicates the disappearance of all tumor(s), PR indicates a \>=30% decrease in the sum of the longest diameters (LD) of tumor(s) referenced to Baseline, and SD represents any case that does not qualify for either PR or progressive disease (PD, which is a \>=20% increase in the sum of LDs). Additionally, per Choi criteria, a response is defined as a \>=10% decrease in the LD of the tumor and/or a \>=15% decrease in the average tumor density measured in Hounsfield Units on a CT scan.

Outcome measures

Outcome measures
Measure	JX-594 Followed by Sorafenib n=25 Participants 1e9 pfu (plaque-forming units) total JX-594 dose on each of up to four (4) JX-594 treatment days. Sorafenib is initiated after 3 JX-594 treatments and briefly interrupted if an optional 4th JX-594 treatment is given.
Number of Participants Achieving Disease Control (DCR) at 12 Weeks mRECIST 1.0	52 percentage of participants Interval 31.31 to 72.2
Number of Participants Achieving Disease Control (DCR) at 12 Weeks Choi criteria	68 percentage of participants Interval 46.5 to 85.05

SECONDARY outcome

Timeframe: Periodically throughout study participation (average of up to 1 year)

Response rate evaluation based on modified RECIST and/or Choi response criteria

Outcome measures

Outcome measures
Measure	JX-594 Followed by Sorafenib n=25 Participants 1e9 pfu (plaque-forming units) total JX-594 dose on each of up to four (4) JX-594 treatment days. Sorafenib is initiated after 3 JX-594 treatments and briefly interrupted if an optional 4th JX-594 treatment is given.
Determine Radiographic Response Rate	1 Participants

SECONDARY outcome

Timeframe: From the date of first treatment until death from any cause, assessed up to approximately 40 months.

Overall survival (OS) is defined as the time from the first dose of Pexa-Vec treatment until death from any cause. For patients not known to have died at the time of the analysis, OS was censored on the date they were last known to be alive. Data were summarized using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	JX-594 Followed by Sorafenib n=25 Participants 1e9 pfu (plaque-forming units) total JX-594 dose on each of up to four (4) JX-594 treatment days. Sorafenib is initiated after 3 JX-594 treatments and briefly interrupted if an optional 4th JX-594 treatment is given.
Overall Survival (OS)	5.65 months Interval 3.29 to 10.94

Adverse Events

JX-594 Followed by Sorafenib

Serious events: 12 serious events

Other events: 25 other events

Deaths: 12 deaths

Serious adverse events

Serious adverse events
Measure	JX-594 Followed by Sorafenib n=25 participants at risk 1e9 pfu (plaque-forming units) total JX-594 dose on each of up to four (4) JX-594 treatment days. Sorafenib is initiated after 3 JX-594 treatments and briefly interrupted if an optional 4th JX-594 treatment is given.
Infections and infestations Biliary tract infection	4.0% 1/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Hepatobiliary disorders Cholangitis	4.0% 1/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Metabolism and nutrition disorders Decreased appetite	4.0% 1/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Hepatobiliary disorders Haemobilia	4.0% 1/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Hepatobiliary disorders Hepatic function abnormal	4.0% 1/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Respiratory, thoracic and mediastinal disorders Hiccups	4.0% 1/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Hepatobiliary disorders Hyperbilirubinaemia	4.0% 1/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	4.0% 1/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	4.0% 1/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	4.0% 1/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Blood and lymphatic system disorders Neutropenia	4.0% 1/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Gastrointestinal disorders Oesophageal varices haemorrhage	4.0% 1/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Respiratory, thoracic and mediastinal disorders Pneumothorax	4.0% 1/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Infections and infestations Rash pustular	4.0% 1/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Infections and infestations Septic shock	4.0% 1/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Injury, poisoning and procedural complications Spinal compression fracture	4.0% 1/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Infections and infestations Staphylococcal infection	4.0% 1/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).

Other adverse events

Other adverse events
Measure	JX-594 Followed by Sorafenib n=25 participants at risk 1e9 pfu (plaque-forming units) total JX-594 dose on each of up to four (4) JX-594 treatment days. Sorafenib is initiated after 3 JX-594 treatments and briefly interrupted if an optional 4th JX-594 treatment is given.
Gastrointestinal disorders Abdominal distension	16.0% 4/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Gastrointestinal disorders Abdominal pain	40.0% 10/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Gastrointestinal disorders Abdominal pain upper	32.0% 8/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Blood and lymphatic system disorders Anaemia	8.0% 2/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Gastrointestinal disorders Ascites	16.0% 4/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
General disorders Asthenia	16.0% 4/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Musculoskeletal and connective tissue disorders Back pain	8.0% 2/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Investigations Blood alkaline phosphatase increased	8.0% 2/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Investigations Blood bilirubin increased	8.0% 2/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
General disorders Chills	76.0% 19/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Gastrointestinal disorders Constipation	24.0% 6/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Respiratory, thoracic and mediastinal disorders Cough	12.0% 3/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Metabolism and nutrition disorders Decreased appetite	28.0% 7/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Gastrointestinal disorders Diarrhoea	36.0% 9/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Gastrointestinal disorders Dyspepsia	16.0% 4/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Respiratory, thoracic and mediastinal disorders Dyspnoea	12.0% 3/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Renal and urinary disorders Dysuria	12.0% 3/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Gastrointestinal disorders Epigastric discomfort	8.0% 2/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Musculoskeletal and connective tissue disorders Flank pain	8.0% 2/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
General disorders Generalised oedema	8.0% 2/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Investigations Haemoglobin decreased	20.0% 5/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Nervous system disorders Headache	48.0% 12/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Hepatobiliary disorders Hepatorenal syndrome	8.0% 2/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Infections and infestations Herpes zoster	8.0% 2/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Metabolism and nutrition disorders Hyperglycaemia	12.0% 3/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Metabolism and nutrition disorders Hyperkalaemia	8.0% 2/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Vascular disorders Hypertension	8.0% 2/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Metabolism and nutrition disorders Hypoalbuminaemia	16.0% 4/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Metabolism and nutrition disorders Hyponatraemia	28.0% 7/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Vascular disorders Hypotension	8.0% 2/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
General disorders Injection site pain	28.0% 7/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Psychiatric disorders Insomnia	8.0% 2/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Investigations International normalised ratio increased	8.0% 2/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Blood and lymphatic system disorders Leukopenia	16.0% 4/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Blood and lymphatic system disorders Lymphopenia	40.0% 10/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Gastrointestinal disorders Melaena	16.0% 4/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Musculoskeletal and connective tissue disorders Musculoskeletal pain	8.0% 2/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Gastrointestinal disorders Nausea	40.0% 10/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Blood and lymphatic system disorders Neutropenia	20.0% 5/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Investigations Neutrophil count decreased	8.0% 2/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	8.0% 2/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
General disorders Pain	16.0% 4/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	20.0% 5/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Investigations Platelet count decreased	16.0% 4/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Skin and subcutaneous tissue disorders Pruritus	8.0% 2/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
General disorders Pyrexia	96.0% 24/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Infections and infestations Rash pustular	16.0% 4/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Gastrointestinal disorders Vomiting	36.0% 9/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Investigations White blood cell count decreased	12.0% 3/25 • Adverse Events were assessed from the first dose of Pexa-Vec up to 28 days after the last dose of Pexa-Vec (average of approximately 2 months). All-cause mortality was assessed from the first dose of Pexa-Vec until death from any cause, up to approximately 40 months . Adverse events were collected and assessed to assess safety and tolerability through 28 days after the last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).

Additional Information

Seunghyun Ma, M.D., Ph.D., Chief Medical Officer

SillaJen, Inc.

Phone: (415) 281-8886

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place