Supporting the developing immune response

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IRX-2 Clinical Results

Data collected in a phase 2a trial of patients with squamous cell carcinoma of the head and neck (SCCHN) demonstrated that neoadjuvant IRX-2 stimulated lymphocyte infiltration (LI) into the tumors and that greater LI was associated with longer survival. The overall 5-year survival rate was 65{991a4518005c0acae110dc2957c3093c53aab3e18df24b42d60853d4cdca3513} (17/26), and in patients with a large change in LI after treatment, there was a greater than 80{991a4518005c0acae110dc2957c3093c53aab3e18df24b42d60853d4cdca3513} probability of survival at 5 years (LIavg vs survival, P<0.05).1 Of the 27 patients evaluable for safety, 85.2{991a4518005c0acae110dc2957c3093c53aab3e18df24b42d60853d4cdca3513} experienced at least one treatment-emergent adverse event (TEAE). The most common (>10{991a4518005c0acae110dc2957c3093c53aab3e18df24b42d60853d4cdca3513}) study drug-related TEAEs included nausea, injection site pain, headache, and dizziness. There were no drug-related deaths reported.2

Adapted from Wolf GT et al. Head Neck. 2011;33(12):1666-1674.

LIavg, average lymphocytic infiltration on visual analog scale; OS, overall survival.

References:

  1. Berinstein NL et al. Cancer Immunol Immunother. 2012;61(6):771-782.
  2. Wolf GT et al. Head Neck. 2011;33(12):1666-1674.