Last updated on April 20, 2014 at 13:20 EDT

Irx Reports Positive Results From Phase II Head and Neck Cancer Trial

July 23, 2008

Irx Therapeutics has announced encouraging preliminary findings from its Phase II clinical trial of IRX-2, its investigational immunotherapy for head and neck cancer.

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.”