We have completed a Phase I clinical trial of IGF-methotrexate (IGF-MTX) in patients with mixed solid tumors and lymphoma at the University of Illinois Chicago: https://clinicaltrials.gov/ct2/show/NCT02045368
The results in that clinical trial show:
- Effective at a surprisingly low dose, about 12 times lower dose than the minimum dose methotrexate is usually used at.
- One Hodgkins lymphoma patient whose cancer progressed on standard drugs is now cancer free after treatment with IGF-MTX.
- Efficacy in three other solid tumor patients.
- ZERO decrease in blood cell counts, the most important side effect of standard chemotherapy.
We are currently conducting a Phase 1a/2b clinical trial of IGF-MTX in myelodysplastic syndrome at the Mayo Clinic: https://clinicaltrials.gov/ct2/show/NCT03175978
- Opened a Phase 1b/2a clinical trial at Mayo Clinic in the blood cancer myelodysplastic syndrome (MDS) January 2018.
- MDS is a deadly blood cancer with no very effective treatments.
- Only two currently approved drugs for MDS, and they don’t work very well.
- IGF-MTX kills MDS cells in the laboratory and is synergistic with the most commonly used of two approved drugs.
- IGF receptors are overexpressed on MDS disease cells.
- IGF-MTX is well suited for this disease because the patients cannot tolerate any decrease in blood cells, and unlike all other cancer chemotherapy, IGF-MTX does not cause any decrease in blood cells.
We plan to open a Phase I clinical trial of a different agent to treat ovarian cancer.