Immunotherapy May Promote Rapid HPV Clearance

Therapeutic vaccine may reduce cervical cancer by fighting disease after infection.

An experimental drug may help ultimately reduce the risk of cervical cancer development.

GTL001 is a therapeutic vaccine developed by Genticel to clear human papillomavirus (HPV) strains 16 and 18, which is present in 99% of cervical cancers. The drug, which will soon be evaluated for safety in a phase 1 clinical trial, is an immunotherapy that fights the disease after an individual has been infected.

"While prophylactic vaccines such as Gardasil are available for those who choose to use them, many women are not choosing to be vaccinated,” said Diane Harper, MD, MPH, MS, chair of the Department of Family and Geriatric Medicine at the University of Louisville. “In addition, most of the women in our population are older than the vaccine movement, so they may not have had the vaccine and may have acquired HPV infections.”

While prophylactic vaccines can prevent some HPV infections, they have not been found effective against existing infections.

The trial is seeking to enroll women aged 25 to 65 years diagnosed with HPV 16 or HPV 18 for the small phase 1 tolerability trial of GTL001 with a 3-month follow-up period. Patients must not have high-grade lesions as determined by Pap smear to participate, they must not have received an HPV vaccine, and must not be pregnant or breastfeeding.

Participants will be administered 2 injections at 6-week intervals, and undergo various tests and assessments. The trial will enroll patients through early 2016 in locations that include Louisville, Philadelphia, and Ohio.