Investigational treatment for cervical dysplasia

Temple University Hospital's Center For Women's Health is participating in a national study to determine the safety and effectiveness of an investigational treatment for cervical dysplasia.

According to the American Cancer Society, approximately 500,000 women are diagnosed with high-grade cervical dysplasia each year, with roughly 10,000 cases progressing to cervical cancer.

For numerous women afflicted with the common sexually transmitted disease known as human papillomavirus (HPV), the immune system can not prevent certain high-risk strains of the virus from causing cervical dysplasia, a common precursor to cervical cancer. "The expected widespread availability of two preventive vaccines may lower the incidence of HPV infection and reduce the risk of cervical cancer," said Enrigue Hernandez, The Abraham Roth Professor and Chair of the Department of Obstetrics and Gynecology at Temple University Hospital and School of Medicine. "However, for those women already infected with HPV, and those who will become infected, there are emerging non-surgical options in development."

HPV vaccines are expected to be a significant advance in women's healthcare, but they will not protect all women from cervical cancer. "Prophylactic vaccines will probably not help the more than 350,000 women in the U.S. already infected with HPV who have moderate to severe cervical dysplasia, a precancerous condition," explained Hernandez.

Amolimogene is an investigational immunotherapeutic from MGI PHARMA, Inc. that is currently being evaluated in a pivotal phase 2 clinical program in multiple centers in the U.S., including Philadelphia. "This product candidate is designed to enhance the body's immune response to cervical dysplasia, and is being developed to offer patients with cervical dysplasia and healthcare providers an option to surgical intervention," explained Hernandez. "Qualified participants must be 25 or younger, with an abnormal Pap test result in the past six months."

According to Hernandez, HPV vaccines have shown protection against certain high-risk strains that cause approximately 55 percent of high-grade cervical dysplasia and 70 percent of cervical cancer cases. "The vaccines do not eliminate the risk of developing cervical cancer," said Hernandez. " They do not provide protection to women who are already infected with HPV, nor have they been shown to cure existing disease or lesions."

Every year, more than 3 million women have an abnormal result on a routine Pap test. Of these women, about 300,000-500,000 receive a diagnosis of moderate to severe cervical dysplasia, caused by certain high-risk HPV strains. "The prophylactic vaccines, which are highly effective in preventing the initial HPV infection, have not demonstrated effectiveness after the infection has progressed to cervical dysplasia," Hernandez explained.

For women diagnosed with high-grade cervical dysplasia, the most widely utilized treatment option is surgery. "The most common surgical procedure is LEEP (Loop Electrosurgical Excision Procedure), which removes the diseased part of the cervix," said Hernandez. "Although LEEP is effective, it may cause complications related to fertility and childbirth, such as cervical stenosis, pre-term delivery, low birthweight babies, and premature rupture of membranes."

Approximately 20 million people, mostly women, are currently infected with HPV, with 6.2 million new infections occurring annually, according to the Centers for Disease Control and Prevention. In a three-year study of college-aged women, 60 percent of subjects were infected with HPV. While the virus clears itself from the body in most women within two years, about a dozen high-risk strains can lead to more serious problems and are the main culprit for cervical cancer.