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VXM01

Phase 1

Stage IV Pancreatic Cancer | Monoclonal antibody | Oncology |OSR Holdings, Inc.|Last Updated: Jun 8, 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
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment72
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01486329VXM01 Phase I Dose Escalation Study in Patients With Locally Advanced, Inoperable and Stage IV Pancreatic CancerPHASE1 COMPLETED 72Dec 1, 2011Dec 1, 2014Jun 8, 20151 Germany
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Study Endpoints
Primary Endpoints
Safety and tolerability
38 days

Number of dose-limiting toxicities and maximum tolerated dose

Secondary Endpoints
Immune response
Up to 24 months
Tumor staging
Up to 24 months
Tumor perfusion
Up to 24 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
VXM01EXPERIMENTALInvestigational anti-angiogenic live cancer vaccine
PlaceboPLACEBO_COMPARATORPlacebo control
Interventions
NameTypeDescription
VXM01BIOLOGICALLive anti-angiogenic cancer vaccine drink solution, escalating dose
PlaceboBIOLOGICALDrink solution
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Written informed consent, signed and dated * Locally advanced, inoperable and stage IV pancreatic cancer patients according to UICC based on diagnostic imaging using computer-tomography (CT) or histological examinations * Male or post-menopausal female * Age above or equal to ...

Countries:Germany
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