THERAPY DOSSIER · th-260b6f67f27c

HemaMax (recombinant human interleukin-12) and m-HemaMax (recombinant murine interleukin-12)

Biologic

Evidence & regulatory context

Mechanism: Not recorded
Target: Not recorded
Injury models: Radiation
Reported indication: Not recorded
First approval: Not recorded
Development stage: In trials, not approved
ChEMBL record: CHEMBL5095343 ↗
ChEMBL max phase: 2 / 4 (development scale, not regulatory approval)
Synonyms: HemaMax; NM-IL-12; Recombinant human interleukin-12; rhIL-12
Note: Not recorded

Clinical trials 9

1 linked trials carry an injury-indication flag. These flags support record-level exploration and sit alongside the stringent aggregate counts described in Methods.

NCT00054405 ↗Injury indicationPHASE1terminated

Phase I IL-12/pulse IL-2 in children with refractory neuroblastoma

Recurrent Neuroblastoma

Enrolment: 40 · Results not recorded

NCT00003149 ↗PHASE2completed

Phase II of Interleukin-12 for Plateau Phase Multiple Myeloma

Multiple Myeloma and Plasma Cell Neoplasm

Enrolment: 40 · Results not recorded

NCT00003210 ↗PHASE2completed

Phase II recombinant human IL-12 for relapsed lymphoma and Hodgkin's disease

Lymphoma · Hodgkin Disease

Enrolment: 105 · Results not recorded

NCT00052377 ↗PHASE1/PHASE2terminated

Phase I/II recombinant human IL-12 (+IL-2) in mycosis fungoides

Cutaneous T-cell Non-Hodgkin Lymphoma · Mycosis Fungoides

Enrolment: 46 · Results not recorded

NCT01468896 ↗PHASE1/PHASE2active not recruiting

Cetuximab plus IL-12 (edodekin alfa) in recurrent/unresectable HNSCC

Head and Neck Squamous Cell Carcinoma

Enrolment: 23 · Results not recorded

NCT00003439 ↗PHASE1completed

Phase I intraperitoneal rhIL-12 in refractory advanced ovarian cancer

Cancer

Enrolment: 36 · Results not recorded

NCT00005604 ↗PHASE1completed

Phase I IV IL-12 plus low-dose IL-2 in advanced malignancies

Solid Tumor

Enrolment: 25 · Results not recorded

NCT00001906 ↗PHASE1completed

Cutaneous leishmaniasis vaccine using rhIL-12 as adjuvant

Cutaneous Leishmaniasis

Enrolment: 50 · Results not recorded

NCT00001128 ↗NAterminated

rhIL-12 with paromomycin/azithromycin for cryptosporidiosis in AIDS

Cryptosporidiosis · HIV Infections

Enrolment: 16 · Results not recorded

Preclinical evidence 1

1 studies reported at therapy level; 1 evidence entries itemised.

PMID 22383962 ↗2012Mixed findings

HemaMax, a recombinant human interleukin-12, is a potent mitigator of acute radiation injury in mice and non-human primates.

MixedRadiationC57BL/6 mice; rhesus monkeysFemale and male mice; male rhesus monkeysn = Mouse survival n=10 per group; monkey survival five groups…SubcutaneousMice approximately 20 ng per mouse as the optimal dose, wit…24 h after total body irradiation; some groups also dosed at 48 h, 72 h or 7 da…

Model: Total body irradiation (mice 8.6-9.0 Gy; rhesus monkeys 6.7 Gy, LD50/30) with no supportive care

A single low dose of interleukin-12 given 24 h after irradiation increased survival in mice and monkeys with improved blood counts, but the highest mouse dose worsened jejunal injury.

Extraction: extract · Supplied extraction confidence: 0.85. Machine-extracted fields require source verification.

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