Amolimogene is an investigational therapeutic designed to specifically augment the body's defensive response to human papillomavirus (HPV). Amolimogene was biologically engineered as a targeted therapy for the treatment of cervical dysplasia.

HOW AMOLIMOGENE WORKS

Amolimogene particles are injected into the leg muscle and encounter cells known as antigen presenting cells, which play a pivotal role in activating the immune system. Once inside the dendritic cells, amolimogene dissolves and the genetic information that codes for parts of the HPV virus is released. The information is then processed, attaches to a protein and transported to the surface of the dendritic cell, attracting immune cells known as T cells. The T cells attach to the protein holding the information and begin to divide, creating many HPV targeted T cells. These cells migrate to the cervix where they encounter HPV expressing cells. Once inside the cervix, the T cells surround and eliminate the abnormal precancerous cells that cause cervical dysplasia. The result can be normal, healthy tissue.

A randomized, placebo controlled phase 2 trial of amolimogene has been completed. A pivotal program is now underway.

About Cervical Dysplasia

One of the most common causes of sexually transmitted infection, HPV has infected more than 20 million people in the United States, with 5.5 million new cases of sexually transmitted HPV infections being reported every year. Infection with HPV results in dysplasia of the uterine cervix in 1-2 million patients per year in the United States.

Over the last 2 decades, the incidence of high-grade cervical dysplasia in women under 35 has doubled. Approximately 350,000 women are diagnosed with high-grade cervical dysplasia each year, with approximately 13,000 cases resulting in cervical cancer. To date, the only available treatment involves removal of important cervical tissue by surgical or ablative means.

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