Therapeutics Focus

HPV Overview

Human papillomavirus (HPV) is a family of viruses that represents one of the most commonly diagnosed sexually transmitted diseases in the world, infecting the genital area of men and women. HPV infections are associated with squamous intraepithelial lesions (precancerous lesions) and anogenital malignancy including cervical, vaginal and anal carcinoma. According to the Center for Disease Control, over 50% of sexually active men and women acquire genital HPV infection at some point in their lives. By age 50, at least 80% of women will have acquired genital HPV infection. About 6.2 million Americans are infected with a new genital HPV infection each year. Cervical cancer is one of the leading causes of cancer deaths in women world-wide, killing more than 232,000 women each year.

Lead Indications

Cervical intraepithelial neoplasia (CIN) refers to the pre-invasive pathological intermediate of cervical cancer. The abnormalities observed on a Pap smear or tissue biopsy of the cervix represent alterations in the degree of differentiation of cervical epithelial cells. In the United States alone, approximately 3.5 million women have abnormal Pap smear tests each year. Approximately 1.2 million of these women have a squamous intraepithelial lesion, of which 200,000 to 300,000 are high-grade.

All of the current treatments for cervical intraepithelial abnormalities, including cryotherapy, laser ablation, excisional conization and loop electrosurgical excision procedure (LEEP), are invasive surgical procedures that often lead to significant side effects including excessive discharge, infection, bleeding, cramping, and cervical incompetence, which may lead to loss of cervical integrity, miscarriage and inability to become pregnant. In addition, these procedures must be performed in a medical facility, which adds to the cost of treatment for cervical intraepithelial abnormalities. A-007 potentially provides a non-invasive treatment option for CIN.

A-007 is also being developed for anal high-grade squamous intraepithelial lesions (HSIL) associated with HPV infection. Like CIN, HSIL can progress to invasive cancer if untreated and all available treatment options are surgically invasive.