Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IRX-2 · 2 trials · 2 indications
EFS is defined as the time from randomization until progression after surgery, or at surgery, if failure to resect gross disease, or at time of death from any cause after randomization.
EFS is defined as the time from randomization until progression after surgery, or at surgery, if failure to resect gross disease, or at time of death from any cause after randomization. Assessment of progression/disease recurrence occurred by physical exam and annual imaging for the duration of the follow up portion of the study. Median EFS was estimated using the Kaplan-Meier method.
The frequency of all Adverse Events (greater than 5%) is reported. All Serious Adverse Events were described.
| Arm | Type | Description |
|---|---|---|
| Regimen 1 | EXPERIMENTAL | IRX Regimen with IRX-2, cyclophosphamide, indomethacin, zinc-containing multivitamin, and omeprazole as neoadjuvant and adjuvant therapy. |
| Regimen 2 | ACTIVE_COMPARATOR | Regimen 1 but without IRX-2 |
| IRX-2 Regimen | EXPERIMENTAL | The IRX-2 regimen is the combination of a 2-week course of IRX-2 itself, an initial dose of cyclophosphamide, and a 3-week course of indomethacin, zinc supplementation, and omeprazole. |
| Name | Type | Description |
|---|---|---|
| IRX-2 | BIOLOGICAL | Method of Administration: Administered for 10 days as subcutaneous bilateral injections in the upper neck. |
| Cyclophosphamide | DRUG | Method of Administration: Cyclophosphamide is administered once by IV |
| Indomethacin | DRUG | Method of Administration: Indomethacin is administered orally for 21 days. |
| Zinc-containing multivitamin | DIETARY_SUPPLEMENT | Method of Administration: Zinc-containing multivitamin is administered orally for 21 days. |
| Omeprazole | DRUG | Method of Administration: Omeprazole is administered orally for 21 days |
| Zinc | DRUG | 21 days of zinc gluconate (65 mg) as part of an oral multivitamin |
Inclusion Criteria: 1. Pathologically confirmed (histology or cytology) clinical Stage II, III, or IVA squamous cell cancer of the oral cavity (excluding lip). Subjects must be staged using AJCC Cancer Staging Manual Edition 7.0 (appendices 1 and 2). 2. Disease surgically resectable with curative i...
IRX-2 is an investigational monoclonal antibody being developed for the treatment of squamous cell carcinoma of the head and neck and squamous cell carcinoma of the oral cavity. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
IRX-2 is being developed by Ernexa Therapeutics Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol ERNA. The company is conducting clinical trials to evaluate the safety and efficacy of IRX-2 in patients with certain types of cancer.
IRX-2 is in Phase 2 clinical development. It has completed two Phase 2 trials, one in squamous cell carcinoma of the head and neck and another in squamous cell carcinoma of the oral cavity. IRX-2 remains investigational and has not received FDA approval.
IRX-2 has been studied in two completed Phase 2 clinical trials. The first, NCT00210470, enrolled 27 patients with operable head and neck cancer. The second, NCT02609386, enrolled 105 patients with newly diagnosed stage II, III, or IVA squamous cell carcinoma of the oral cavity.
IRX-2 is the primary name for this investigational drug. No alternative names have been reported for IRX-2 in clinical trial registries or company communications. It is a distinct monoclonal antibody being developed by Ernexa Therapeutics Inc.