Approval Probability
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Adjusted LOA
ML Risk
EC Aspirin · 1 trial · 10 indications
This will be assessed by the increase in the total number of tumor infiltrating CD8+ T cells in the radical prostatectomy specimen (measured as cell density of CD8+ cell by immunohistochemistry), comparing Arm A versus Arm B versus Arm C. Will be natural log transformed prior to analysis. The primary analysis will consist of testing the single degree of freedom planned contrast at alpha = .10 that the 3 treatment means are in the ratio of 3:2:1 (contrast coefficients 3, -2, -1) for groups A, B and C, respectively groups. If this test rejects the null hypothesis of no group differences, will proceed to estimate group means and pairwise differences between groups with 90% confidence intervals. Non-overlapping confidence intervals will serve as evidence of differential treatment effects.
| Arm | Type | Description |
|---|---|---|
| Arm I (EC aspirin, interferon alpha, rintatolimod, surgery) | EXPERIMENTAL | Patients receive aspirin PO BID on days -7 to 7. Patients also receive recombinant interferon alfa-2b IV over 20 minutes and rintatolimod IV over 2 hours on days 1-3 and 8-10 in the absence of disease progression or unacceptable toxicity. Patients then undergo radical prostatectomy on or between day 17-24.. |
| Arm II (EC aspirin, rintatolimod, surgery) | EXPERIMENTAL | Patients receive aspirin PO BID on days -7 to 7 and rintatolimod IV over 2 hours on days 1-3,and 8-10 in the absence of disease progression or unacceptable toxicity. Patients then undergo radical prostatectomy on or between day 17-24. |
| Arm III (radical prostatectomy) | ACTIVE_COMPARATOR | Patients undergo radical prostatectomy about 4 weeks after enrollment. |
| Name | Type | Description |
|---|---|---|
| EC Aspirin | DRUG | Given PO |
| Radical Prostatectomy | PROCEDURE | Undergo radical prostatectomy |
| Recombinant Interferon Alfa-2b | BIOLOGICAL | Given IV |
| Rintatolimod | DRUG | Given IV |
Inclusion Criteria: * Histologically confirmed, localized prostate adenocarcinoma patients who are planning to have a radical prostatectomy. * Diagnostic prostate biopsy must have been obtained within 6 months patients who had biopsies at outside facilities may be eligible if tissue availability an...
EC Aspirin is being studied as a treatment for prostate adenocarcinoma, specifically in patients with Stage I to Stage IIIC prostate cancer. It is being evaluated in a Phase 2 clinical trial in combination with rintatolimod, with or without interferon-alpha 2b, given before surgery. The trial is active but not recruiting.
EC Aspirin is being developed by AIM ImmunoTech Inc., a biopharmaceutical company traded on the NYSE American under the ticker symbol AIM. The company is conducting a Phase 2 clinical trial of EC Aspirin in prostate adenocarcinoma.
EC Aspirin is in Phase 2 clinical development. It is an investigational drug being studied in a Phase 2 trial for prostate adenocarcinoma. The drug is not approved by the FDA and remains in clinical testing.
EC Aspirin is being studied in one active Phase 2 clinical trial, NCT03899987, titled "Aspirin and Rintatolimod With or Without Interferon-alpha 2b in Treating Patients With Prostate Cancer Before Surgery." The trial is enrolling 12 male patients aged 18 years and older in the United States.
EC Aspirin is a small molecule being studied in combination with rintatolimod and optionally interferon-alpha 2b for prostate adenocarcinoma. The trial is active-controlled and randomized, but not double-blinded. The specific molecular target of EC Aspirin has not been disclosed.