Advaxis is entering into a clinical trial collaboration agreement with the Gynecologic Oncology Group (GOG) Foundation to evaluate safety and efficacy of the company’s lead cancer immunotherapy ADXS-HPV in a global Phase III trial to treat cervical cancer.

ADXS-HPV is an investigational Lm-LLO immunotherapy designed to generate an immune response to the HPV-associated tumour specific oncogene.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

Both parties will conduct an adequate and well-controlled Phase III clinical trial of concurrent chemotherapy and radiation therapy (CCRT) compared to CCRT combined with ADXS-HPV in women diagnosed with high-risk, locally advanced cervical cancer.

"ADXS-HPV is an investigational Lm-LLO immunotherapy designed to generate an immune response to the HPV-associated tumour specific oncogene."

Advaxis executive vice-president Dr David Mauro said: "By evaluating ADXS-HPV in this high-risk, locally advanced setting early in the onset of the disease, we believe there is a greater potential to impact the course of early stage cervical cancer and survival of the patient."

Before starting the trial, Advaxis will discuss the proposed Phase III programme with US Food and Drug Administration (FDA) and will update its investigational new drug (IND) submission.

The company also intends to request a special protocol assessment (SPA), a declaration from the FDA that a Phase III trial’s design, clinical endpoints and statistical analyses are supportive for FDA approval.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

GOG Foundation vice-president Larry Copeland said: "The opportunity to evaluate the ADXS-HPV immunotherapy in women with cervical cancer is compelling and the GOG Foundation is committed to bring forward novel therapies to gynaecologic cancer patients with unmet needs."

The GOG Foundation is focused on conducting clinical research for the prevention and treatment of all gynaecologic cancers, such as ovarian cancer, cervical cancer, endometrial cancer, vulvar cancer, and vaginal cancer.