Advaxis will host a research reception at the Society of Gynecologic Oncology’s 48th Annual Meeting on Women’s Cancer to provide an overview and updates of its cervical cancer clinical trial program.
According to a press release, the reception will be held at the Gaylord Convention Center in National Harbor, Maryland, from 5:30 to 7 p.m. on Monday, March 13.
During the reception, event speakers will provide an overview of Advaxis’s cervical cancer clinical trial program of Axal (axalimogene filolisbac), a new vaccine approach that uses live attenuated bacteria and is being investigated for the treatment of women with advanced cervical cancer.
Advaxis scientists genetically altered Listeria monocytogenes to present the HPV-16 protein at the surface of cancer cells. Cancer-fighting T-cells recognize the protein, then go after HPV-positive cancer cells.
Advaxis will provide an update of the AIM2CERV Phase 3 clinical trial (NCT02853604) designed to compare the disease-free survival of Axal to a placebo, administered following concurrent chemotherapy and radiotherapy (CCRT), as adjuvant treatment for high-risk locally advanced cervical cancer with curative intent.
The AIM2CERV trial, authorized under the U.S. Food and Drug Administration’s (FDA) Special Protocol Assessment (SPA) process, is being conducted in collaboration with the Gynecologic Oncology Group (GOG) Foundation.
In the trial, the secondary, or adjuvant, therapy is being given to 450 women with locally advanced carcinoma of the cervix who have had concurrent chemotherapy and radiation treatments.
In addition to evaluating whether Axal can increase patients’ disease-free survival rate, the study will assess its impact on overall survival rate, safety and tolerability.
A previous Phase 2 clinical trial in recurrent/refractory cervical cancer revealed that Axal led to a 50 percent increase in patients’ 12-month overall survival rate, and a manageable safety profile either when used alone, or in combination with chemotherapy.
The FDA granted Orphan Drug and Fast Track designation to Axal as an adjuvant treatment for high-risk locally advanced carcinoma of the cervix, as well as Orphan Drug status for stage 2-4 cervical cancer.
More information on the event, and an online registration form, can be found by visiting the Advaxis website at http://www.advaxis.com/sgo2017.