Advaxis announces master clinical trial agreement
PRINCETON, N.J.—Biotechnology company Advaxis Inc. has announced an expansion of its collaboration with the GRU Cancer Center at Georgia Regents University by way of a master clinical trial agreement to conduct four Phase 1/2 clinical trials. The trials will study ADXS-HPV for cervical cancer and ADXS-cHER2 for breast cancer, Advaxis’ two lead immunotherapies. The trials will evaluate ADXS-HPV in patients with surgically treatable cervical cancer prior to surgery, the optimal dose of ADXS-HPV and PD-1 antibody in patients with recurrent or refractory cervical cancer and high dose, repeating cycles of the drug in recurrent or refractory cervical cancer. The trials will also look at ADXS-cHER2 in women with Her2/neu over-expressing breast cancer with measurable disease who have progressed after prior standard therapy. Dr. Samir Khleif, director of GRU Cancer Center, will supervise the trials.