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AG-707

Phase 1

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

AG-707 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Oct 2005

AG-707 target and mechanism

Molecular targetHSV-2 antigens
Target classAntigen
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment35

FDA Designations

No designations recorded

AG-707 clinical trials

AG-707 · 1 trial · 1 indication

Phase 1 1
NCT00231049Trial Evaluating Safety, Tolerability and Immune Response of AG-707Genital Herpes
COMPLETED35 Analytics
PHASE1COMPLETED
Trial Evaluating Safety, Tolerability and Immune Response of AG-707
Genital HerpesUnlock trial analytics

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 to 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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Frequently asked questions about AG-707

What is AG-707 used for?

AG-707 is an investigational therapy being developed for genital herpes, a sexually transmitted infection caused by herpes simplex virus type 2. It is a small molecule designed to stimulate an immune response against the virus. Agenus Inc. is evaluating it in clinical development, and it has not been approved for commercial use.

What does AG-707 target?

AG-707 targets HSV-2 antigens, which are proteins from the herpes simplex virus type 2. By presenting these antigens, the therapy aims to elicit an immune response against the virus. This antigen-based approach is intended to help the body recognize and combat HSV-2, the virus responsible for genital herpes.

Who is developing AG-707?

AG-707 is being developed by Agenus Inc., a biotechnology company traded on the Nasdaq under the ticker symbol AGEN. Agenus focuses on immuno-oncology and infectious disease therapies. The company has advanced AG-707 into clinical testing for genital herpes.

What phase is AG-707 in?

AG-707 is in Phase 1 clinical development. It has completed a Phase 1 trial evaluating its safety, tolerability, and immune response in patients with genital herpes. As an investigational product, it has not received FDA approval and remains in the early stages of clinical research.

What clinical trials is AG-707 in?

AG-707 has been studied in a completed Phase 1 trial, NCT00231049, titled "Trial Evaluating Safety, Tolerability and Immune Response of AG-707." The trial enrolled 35 participants with genital herpes in the United States. It was randomized but uncontrolled and not double-blind, and it has finished.