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GL-ONC1

Phase 1

Cancer of Head and Neck | Monoclonal antibody | Oncology |Genelux Corporation|Last Updated: Aug 25, 2015

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment19
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01584284Safety Study of Attenuated Vaccinia Virus (GL-ONC1)With Combination Therapy in Head & Neck CancerPHASE1 COMPLETED 19Apr 1, 2012Jul 1, 2015Aug 25, 20151 United States
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Study Endpoints
Primary Endpoints
Safety and Tolerability as measured by the number of patients with Adverse Events, as well as type of AE and frequency
Baseline up to week 23 Post-treatment

Evaluation of changes in laboratory tests (hematological, chemistry), immunogenicity and physical examination

Secondary Endpoints
Presence of Virus in Tumor
At baseline (Within 4 weeks of Treatment Day 1); 9-13 days post viral injection
Determine Initial Susceptibility of tumor to viral infection
At baseline (Within 4 weeks of Treatment Day 1)
Anti-Tumor Activity (Early Efficacy)
Change from baseline up to week 23 Post-treatment (week 23)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
GL-ONC1BIOLOGICALA genetically-engineered vaccinia virus administered via intravenous infusion . Cohorts 1, 2, 3: Frequency: 1x in Week 1; Cohort 4: 1x again 1x in Week 2; Cohort 5: 1x Week 1, 1x Week 2, 1x Week 3, 1x Week 4.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Confirmed diagnosis of histologically or cytologically documented Stage III to IVB primary, non-metastatic head and neck cancer for newly diagnosed patients with no prior disease-related treatment (e.g., chemotherapy, radiation treatment, surgery, etc.). * American Joint Commi...

Countries:United States
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