Developed by UAMS' Mayumi Nakagawa, M.D., Ph.D., the therapeutic vaccine will be tested on women who have precancerous lesions. About 300 women with recent abnormal Pap smears indicating possible high grade intraepithelial lesions (HSIL) will be screened. Those who are confirmed to have HSIL will be eligible for vaccination.
"I am tremendously excited to be entering this very important phase of the study," said Nakagawa, an associate professor of pathology at the Winthrop P. Rockefeller Cancer Institute. "It means that we are another step closer to saving women's lives."
An estimated 12,170 new cases of invasive cervical cancer will be diagnosed in the United States in 2012, and about 4,220 women will die from the disease, according to the American Cancer Society.
The clinical trial is supported by a $3.3 million grant from the National Institutes of Health (NIH) National Cancer Institute (NCI). Phase I clinical trials include evaluating a new drug or treatment in a small group of people to determine such things as a safe dosage range and potential side effects before the trial becomes available to a larger group of participants.
The Phase I clinical trial is being coordinated by the UAMS Translational Research Institute. Anyone interested in enrolling can call (501) 526-7657 or email to: email@example.com.
Nakagawa's vaccine differs from an existing HPV vaccine that is used for women or girls who have never been exposed to HPV.
About 50 percent to 80 percent of sexually active men and women are infected with genital HPV at some point in their lives. In about 90 percent of cases, the virus clears itself from the body naturally. Where the virus persists, it can lead to cancer. HPV is known to cause cervical, vaginal, oral and anal cancers.
Study participants will be enrolled at the UAMS Gynecology Clinics by William Greenfield, M.D., associate professor of obstetrics and gynecology, and his colleagues. Vaccinations will be administered at the Translational Research Institute's Clinical Research Services Core on the UAMS campus.
The UAMS Translational Research Institute's mission is to help accelerate research that will improve the health and health care of people in Arkansans and across the country. It was established with major funding from the National Institutes of Health (NIH) in 2009 and is one of 60 NIH Clinical and Translational Science Awardees. Funding from NIH flows through the National Center for Advancing Translational Sciences (NCATS).
The production of the clinical grade vaccine was a collaborative effort among scientists at CPC Scientific, who produced the cGMP peptides (synthetically made fragments of HPV protein called E6); those at Integrity Bio Inc., who conducted solubility testing, formulation development, and manufacturing; and at Southern Research Institute, where the safety study was conducted. Candin, which will be used to enhance immune response, is produced by Allermed.
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