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Adenoviral-mediated Interferon-beta

Phase 1

Pleural Mesothelioma | Monoclonal antibody | Oncology |Biogen Inc.|Last Updated: Mar 18, 2020

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment17
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00299962Gene Therapy for Pleural MalignanciesPHASE1 COMPLETED 17 — — Mar 1, 2006Oct 1, 2009Mar 18, 20201 United States
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Study Endpoints
Primary Endpoints
To determine toxicity of two doses of intrapleural BG00001 (Ad.hIFN-β over 8 days, and
Through Day 85
Secondary Endpoints
To assess systemic and intrapleural cytokine responses as well as cellular and humoral immune responses after repeated BG00001 instillation,
Through Day 85
and to assess, in a preliminary way, efficacy via tumor regression, time to progression and survival.
15 years or until subject dies, whichever comes first
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose level 4EXPERIMENTAL -
Dose level 5EXPERIMENTAL -
Dose Level 1EXPERIMENTALon Days 1 and 15
Dose Level 2EXPERIMENTALOn Days 1 and 15
Dose Level 3EXPERIMENTALOn Days 1 and 15
Interventions
NameTypeDescription
Adenoviral-mediated Interferon-betaBIOLOGICALBG00001 at doses 1.5 x 10e12 and 3 x 10e12 viral particles Days 1 and 8
SCH 721015BIOLOGICALComparison of different doses and frequency of investigational agent
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * must have malignant pleural effusion from mesothelioma or metastatic from primary lung, breast, gastrointestinal, genitourinary, melanoma, or sarcoma * must have evaluable disease * must have ECOG performance status of 2 * must have pleural space involved with tumor accessible...

Countries:United States
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