Kristie McNealy, MD

Cervical dysplasia is a common and frightening condition, affecting more than a third of all women who have an abnormal pap smear in the US each year. Also known as cervical intraepithelial neoplasia (CIN), cervical dysplasia is caused by the human papilloma virus (HPV). While it is treatable, typical treatment for the condition is a LEEP, which is painful and can result in the development of an incompetent cervix. This condition makes it difficult for women to successfully carry a pregnancy.

That all may change though, because a new live Listeria vaccine made by Advaxis Inc. has been shown to be safe for women in a Phase I/II trial. The immunotherapy treatment, named Lovaxin C, was designed to trigger an immune response against cancer cells. It was given to a group of women with either advanced, recurrent, or progressive cervical cancer, and with the exception of two women, all the patients in the study had end stage (IVb) disease.

The vaccine was given at different doses to study side effects. All of the women experienced fevers, nausea and other flu like symptoms, consistent with immune stimulation. Women in the lower two dose groups were able to manage their symptoms with over-the-counter medications, while the highest dose was found to be intolerable, providing researchers with a dose ceiling, which is important at this stage of clinical testing.

While measuring tumor response was not the focus of this phase of the study, some women had a reduction in tumor volume and two tumors disappeared completely. One of the women with end stage disease experienced such a good response to treatmnent with Lovaxin C that she was removed from the trial early to restart conventional chemotherapy. After additional treatment and surgery, she was reportedly free of disease.

Hopefully, this treatment will fare equally well as it moves through additional clinical trials. If it can be used to safely and successfully treat cervical dysplasia caused by HPV, it will help millions of women avoid the potential risks of having a LEEP, potentially preventing them from developing an incompetent cervix and dealing with the pain of a stillborn or premature baby.

It’s important to note that this live bacteria vaccine is different than the vaccine GARDASIL, which has been marketed by MERK with the “One Less” campaign. That vaccine is designed to prevent infection with HPV types 16 and 18, two of the most common HPV types found in cervical cancer patients. GARDASIL does not treat cervical cancer.

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