Advaxis To Start Phase 1/2 Trial For Cervical Cancer Drug
Clinical stage biotech firm Advaxis announced that it has received Institutional Review Board (IRB) approval from the Georgia Regents University (GRU) Cancer Center to start a Phase 1/2 trial investigating higher doses and repeat cycles of ADXS-HPV in patients with recurrent cervical cancer. ADXS-HPV is the company's lead Lm-LLO cancer immunotherapy product designed to target HPV-associated cancers.
The trial will assess the efficacy and immunological effect of the highest-tolerated dose of ADXS-HPV administered in repeat cycles of therapy to patients with cervical cancer who experienced disease recurrence after receiving one prior cytotoxic treatment regimen. An earlier Phase 2 clinical study of the drug showed that a single cycle treatment achieved complete and partial tumor responses as well as possible survival benefit.
Dr. Robert Petit, CEO of Advaxis, said, “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.”
The company said it believes repeat treatment cycles at higher doses may result in further improvement of positive clinical benefit observed in previous studies.
Recurrent cervical cancer remains a deadly disease and is known to be resistant to treatment. Patients need the strongest treatment available to prolong survival, said Dr. Petit. “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 Tcells.”
The Phase 1/2 trial will be conducted at the GRU Cancer Center under the leadership of Director Dr. Samir Khleif.