THE TWO IRX-2 REGIMENS

IRX-2 is not given alone. Instead, it is given as part of regimens containing additional pharmacologic agents that can support the promotion of an anticancer immune response. One regimen (the IRX-2 Neoadjuvant Regimen) is given before curative surgery, another (the IRX-2 Booster Regimen) is given after surgery.
The components of each regimen are the same, except for differences in administration timing and location, as well as treatment duration.

COMPONENTS OF THE IRX-2 REGIMENS

IRX-2 NEOADJUVANT REGIMEN

The IRX-2 neoadjuvant regimen is administered over a 21-day period prior to curative surgery and is followed by radiation therapy and chemotherapy as indicated. In the INSPIRE study, the IRX-2 biologic is not included in the neoadjuvant regimen given to patients in the control arm.

IRX-2 BOOSTER REGIMEN

Following neoadjuvant treatment and curative surgery, patients receive 4 additional treatments with an abbreviated IRX-2 Booster Regimen given 3, 6, 9, and 12 months after surgical resection. (The “3-month” booster regimen may be initiated before or after completion of radiation or chemoradiation adjuvant therapy.)

The IRX-2 Booster Regimen is administered over 10 days, during which it is injected bilaterally into the deltoid region for 5 days. The booster regimen comprises:

  • IRX-2 subcutaneously given any 5 days between days 3 and 10 to patients in the investigational arm only
  • Low-dose cyclophosphamide intravenously on day 1
  • Indomethacin, zinc-containing multivitamins and omeprazole orally on days 1-10

During the IRX-2 Booster Regimen, agents are administered at the same daily doses as in the IRX-2 Neoadjuvant Regimen.

© 2016 IRX Therapeutics