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news.The US Food and Drug Administration (FDA) has cleared Advaxis' investigational new drug (IND) application to conduct a Phase I/II clinical trial of its Lm-LLO immunotherapy ADXS-PSA (ADXS31-142) to treat patients with previously treated, metastatic castration-resistant prostate cancer (mCRPC).
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The trial is designed to evaluate the safety and efficacy of ADXS-PSA as a monotherapy and in combination with Merck’s Keytruda, the first anti-PD-1 (programmed death receptor-1) therapy approved in the US.
The companies intend to start patient enrolment in the open-label Phase I/II clinical trial in the first quarter of 2015.
The trial will be the first-in-human study of Advaxis’s lead Lm-LLO immunotherapy product candidate in prostate cancer.
The dose-escalating Phase I part of the trial is designed to establish the maximum tolerated dose of ADXS-PSA when used alone and in combination with Keytruda, while the Phase II portion will evaluate the safety and efficacy of the combination immunotherapy regimen.
Advaxis president and chief executive officer Daniel O’Connor said: "Combinations of immunotherapies are the future of cancer research.
"This open-label study will provide Advaxis clinical data by which we can evaluate the potential of our proprietary Lm-LLO immunotherapy technology to enhance the activity of an anti-PD-1 antibody.
"During preclinical studies, our immunotherapies demonstrated a synergistic anti-tumor immune response when combined with a PD-1 inhibitor."
Both the firms will jointly oversee the conduct of the trial and will use the results to determine the future clinical development program for the combination.