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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 clinical trial of ADXS-HER2 (ADXS31-164) to treat patients with metastatic HER2 expressing solid tumors.
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In the first half of 2015, the company intends to start patient enrollment in the Phase I trial, which will be the first-in-human study of its lead Lm-LLO immunotherapy product for HER2 expressing cancers.
The trial will evaluate the safety and tolerability of ADXS-HER2 as a monotherapy in patients with metastatic HER2 expressing solid tumors such as breast, gastric, esophageal, and osteosarcoma.
The company said that results from the trial will be used to determine the future clinical development program of ADXS-HER2.
In May 2014, the company secured orphan drug designation from the FDA for ADXS-HER2 in osteosarcoma.
Advaxis president and chief executive officer Daniel O’Connor said: "We are very pleased to have received FDA acceptance for our ADXS-HER2 IND application and look forward to commencing the Phase 1 clinical study in HER2 expressing solid tumors.
"This trial will provide important insights about the potential of ADXS-HER2 in HER2 expressing cancers such as breast, gastric, esophageal and osteosarcoma."
Currently, the safety and efficacy of ADXS-HER2 is being evaluated in an ongoing Phase I/II veterinary clinical study in pet dogs with osteosarcoma, conducted by Nicola Mason of the University of Pennsylvania School of Veterinary Medicine.