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AG-707

Phase 1

Genital Herpes | Small molecule | Infectious Disease |Agenus Inc.|Last Updated: Oct 27, 2008

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
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment35
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00231049Trial Evaluating Safety, Tolerability and Immune Response of AG-707PHASE1 COMPLETED 35 — — Mar 1, 2006 -Oct 27, 20083 United States
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Study Endpoints
Primary Endpoints
Determine the overall safety profile of three different dose levels of AG-707 vaccination (with and without an adjuvant, QS-21) at 80, 240 and 400 µg compared to placebo and QS-21 alone in herpes simplex virus-2 (HSV-2) seropositive adults
Secondary Endpoints
Determine immune response to AG-707 vaccination (with and without QS-21) at dose cohorts of 80, 240, and 400 µg as compared to placebo and QS-21 alone
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
AG-707DRUG -
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Patients must be seropositive for HSV-2 (+/- HSV-1) and have a documented history of clinically active genital herpes (at least one prior outbreak). * Patients must be seronegative for HIV. * Patients must be seronegative for hepatitis B and C * Have baseline chemistry and hem...

Countries:United States
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