Cervical Cancer Immunotherapy Candidate Launches Phase 3 Study

AIM2CERV cervical cancer vaccine study is designed to compare the disease-free survival rate of women who take AXAL

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There is a group of women battling cervical cancer with a very specific vaccine need.

These women have a high probability of disease recurrence within 4 years of diagnosis. And, the prognosis is very grave for those who experience a recurrence.

The good news is a vaccine candidate AXAL has launched a Phase 3 clinical study

Axal is a new vaccine approach that uses the live attenuated bacteria Listeria monocytogenes genetically altered to present the HPV-16 protein at the surface.

The protein is then recognized by T-cells, which will become specific to HPV-positive cancer cells.

The multicenter, randomized, placebo-controlled AIM2CERV study is designed to compare the disease-free survival (DFS) rate of women who take AXAL.

This vaccine candidate is focused on high-risk, locally advanced carcinoma of the cervix (HRLACC) following concurrent chemotherapy and radiation therapy.

These vaccines try to get the immune system to mount an attack against cancer cells in the body. Instead of preventing disease, they are meant to get the immune system to attack a disease that already exists.

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The secondary therapy objective of this clinical study is being given to 450 women with locally advanced carcinoma of the cervix, who have had concurrent chemotherapy and radiation treatments.

This Phase 3 trial is being conducted in collaboration with the Gynecologic Oncology Group (GOG) Foundation under a Special Protocol Assessment granted in June 2016 by the U.S. Food and Drug Administration (FDA).

These researchers are optimistic, based on the finding of the Phase 2 clinical study of AXAL. This Phase 2 study reported a 50 percent increase in patients’ 12-month overall survival rate.

Cervical cancer is often caused by the human papillomavirus (HPV). Nearly all cases of cervical cancer can be attributable to HPV infection, says the CDC.

Most sexually active women and men will be infected with HPV at some point in their lives and some may be repeatedly infected.

There are many types of HPV, and many do not cause problems.

HPV infections usually clear up without any intervention within a few months after acquisition, and about 90% clear within 2 years. A small proportion of infections with certain types of HPV can persist and progress to cancer.

In 2014:

  • 12,578 women in the United States were diagnosed with cervical cancer.
  • 4,115 women in the United States died from cervical cancer.