Advaxis Initiates A Phase 1/2 Trial Evaluating Higher Doses And Repeat Cycles Of Cervical Cancer Drug

Advaxis Inc., a biotechnology company that focuses on developing immunotherapies to treat cancer, has announced that the Georgia Regents University Cancer Center has received approval from the Institutional Review Board to begin Phase ½ trials for the ADXS-HPV treatment. ADXS-HPV is an immunotherapy which works to fight against cervical cancer. In particular, the Phase ½ trials will be evaluating higher doses of the treatment as well as repeat cycles of ADXS-HPV patients that have recurrent cervical cancer. The trials will be completed at Georgia Regents University, and will be led by Dr. Samir Khleif, who is also the director of the university’s cancer center. ADXS-HPV is currently Advaxis’s leading cancer immunotherapy drug candidate.

Dr. Robert Petit, who works as the chief scientific officer at Advaxis, commented on the new clinical trials. “We have already seen safety and efficacy data from a single cycle of ADXS-HPV at the low dose of 1x109 CFU. We hope to improve on the clinical outcomes seen in our Phase 2 trial by using a higher dose and repeat cycles of treatment. This high-dose Phase 1/2 clinical study will run in parallel with our planned pivotal Phase 3 registration program for ADXS-HPV in patients with cervical cancer,” he said. “The 100-1000 fold greater attenuation of the Advaxis vector coupled with the higher secretion of the tumor antigen per CFU, should pair together to significantly amplify signaling of the immune system and result in a greater number of cancer fighting T cells. Recurrent cervical cancer is a fatal disease and is resistant to treatment. These women deserve the strongest treatment effect we can generate, in an attempt to prolong their survival.”

Previous studies of the ADXS-HPV immunotherapy have found that the drug is well tolerated in women with recurrent cervical cancer under a single cycle. It also showed partial tumor responses and an apparent survival benefit.