Advaxis: FDA Accepts INDA To Begin Trials Of ADXS-PSA Along With KEYTRUDA

(RTTNews) - Advaxis, Inc. (ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, said the U.S. Food and Drug Administration has cleared its Investigational New Drug application to conduct a Phase 1/2 clinical study to evaluate the combination of ADXS-PSA (ADXS31-142) with KEYTRUDA (pembrolizumab), in patients with previously treated, metastatic castration-resistant prostate cancer.

The clinical trial, which will be the first-in-human study of Advaxis's lead Lm-LLO immunotherapy product candidate in prostate cancer, is expected to begin patient enrollment in the first quarter of 2015.

The open-label Phase 1/2 clinical trial is designed to evaluate the safety and efficacy of ADXS-PSA as a monotherapy and in combination with KEYTRUDA, the first anti-PD-1 therapy approved in the U.S. KEYTRUDA is developed and marketed by Merck.

The Phase 1 part of the study will be a dose-escalating study designed to establish the maximum tolerated dose of ADXS-PSA when used alone and in combination with KEYTRUDA.

The Phase 2 portion will assess the safety and efficacy of the combination immunotherapy regimen.

Advaxis and Merck will collaboratively oversee the conduct of the study and will use the results from the trial to determine the future clinical development program for the combination.

ADXS-PSA and KEYTRUDA are members of a new class of cancer treatments known as immunotherapies, which are designed to enhance the body's own defenses in fighting cancer.