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ADXS-HPV Clinical Program for HPV-Associated Illnesses

ADXS-HPV is currently in Phase 2 clinical development for recurrent/refractory and advanced cervical cancer, CIN 2/3, and HPV caused head and neck cancers.

Links to ADXS-HPV trials:

ADXS-HPV is an immunotherapy that is designed to target cells expressing the HPV gene E7. Expression of the E7 gene from high-risk HPV variants is responsible for the transformation of infected cells into dysplastic and malignant tissues. Eliminating these cells can eliminate the dysplasia or malignancy. ADXS-HPV is designed to infect antigen-presenting cells and direct them to generate a powerful, cellular immune response to HPV E7. The resulting cytotoxic Tcells infiltrate and attack the tumors while specifically inhibiting tumor Tregs and MDSCs in the tumors that are protecting it.

The American Cancer Society estimates that there will be about 12,710 newly diagnosed cervical cancer cases in the U.S. in 2011.

About 500,000 patients per year are diagnosed with high grade CIN (2-3), the predecessor condition to cervical cancer (source: Jones HW, Cancer 1995:76:1914-18; Jones BA and Davey, Arch Pathol Lab Med 2000; 124:672-81).

In 2009, the CDC reported that about 45% of women aged 20 to 24 had HPV.  HPV causes a number of different types of cancer. The same types of genital HPV that cause cervical cancer (HPV-16, HPV-18) cause about 8 out of 10 squamous cell anal cancers. In addition, nearly half of cancers of the vulva and about 7 out of 10 vaginal cancers are HPV-related. Some other genital cancers (cancers of the penis and urethra) and some head and neck cancers (mostly the throat, tongue, and tonsils) are also related to high-risk types of HPV. For additional information about HPV, please visit: http://www.cancer.org/.

  • ADXS-HPV Clinical Trials


    ADXS-HPV: Cervical Cancer - Completed
    Phase 1 Study of ADXS-HPV in Patients with Metastasized, Progressive Cervical Cancer that has not Responded to Previous Treatment
    15 Patients
    Endpoint: Safety
    2006 – 2008
    3 sites: Serbia, Mexico, Israel
    Key Findings: Well-tolerated, maximum tolerated dose established

    ADXS-HPV: CIN 2/3, US
    Randomized, Placebo-controlled, Single-Blind Dose Ranging Phase 2 Study of ADXS-HPV in Patients with CIN 2/3
    120 Patients
    Endpoints: Safety, efficacy determination by CIN remission at LEEP
    April 2010 – June 2013
    Low dose: COMPLETE
    Mid dose: Q2 - Q3, 2012
    High dose: Q1 - Q2, 2013
    Multicenter 15 sites, US only
    Status: 40 patient low dose leg completed, mid dose enrolling

    ADXS-HPV: Cervical Cancer, India
    Phase 2 Study of ADXS-HPV +/- Cisplatin in Patients with Metastasized, Progressive Cervical Cancer that has not Responded to Previous Treatment
    110 Patients
    Endpoints: Safety & efficacy
    Nov 2010 – 2012
    (LP/FV – Q4 2011)
    Multicenter > 15 sites, India only
    Status: Study ongoing

    ADXS-HPV: Cervical Cancer, US
    Phase 2 Study of ADXS-HPV in Patients with Metastasized, Progressive Cervical Cancer that has not Responded to Previous Treatment
    67 Patients
    Endpoints: Safety, efficacy and immunology
    Q3 2011 – Q4 2013
    Multicenter, US only
    Sponsor: NCI/GOG
    Status: Study ongoing

    ADXS-HPV: Head & Neck Cancers, UK
    Phase 1/2 Dose Escalation Trial of ADXS-HPV in Patients with Head & Neck Cancer
    27 Patients
    Endpoints: Safety, dose selection and immunology
    Q4 2011 – TBD
    Multicenter, 3 sites, UK only
    Sponsor: Cancer Research UK
    Status: Pending study start approval