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news.Irx Therapeutics has announced encouraging preliminary findings from its Phase II clinical trial of IRX-2, its investigational immunotherapy for head and neck cancer.
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The preliminary results of the study suggest that IRX-2 is safe and well tolerated and survival data show promising results when compared to historical controls.
In this multi-center study, 27 newly diagnosed head and neck cancer patients were treated with the IRX-2 regimen as a neoadjuvant therapy prior to curative cancer surgery.
The vast majority of patients had locally advanced disease, stage III or IVa. The preoperative IRX-2 regimen was associated with significant changes in immune cells consistent with an anti-tumor immune response, with some patients showing tumor shrinkage after treatment.
At 18 months of follow-up in the stage IVa cohort, 13 of 16 patients, 81%, of IRX-2 treated patients were alive. The IRX-2 regimen was well tolerated by all patients and had a good safety profile.
John Hadden II, president and CEO of Irx, said: “We are encouraged by the Phase II study results and, consequently, are busy preparing to launch the Inspire trial, our pivotal Phase III study.”