Erimos has conducted multiple Phase I clinical trials with Terameprocol at various top tier institutions and clinical trial sites in the U.S. In collaboration with the Adult Brain Tumor Consortium, we are currently undertaking a phase I trial study in treating patients with high-grade glioma. Additionally, ongoing pre-clinical studies have also shown anti-viral effects. Erimos has evaluated the intravenous, intravaginal and intratumoral administration of terameprocal to patients with various forms of cancer.
Terameprocol - Oral Capsules
Currently ongoing is a Phase 1 clinical study of a new formulation of Terameprocol administered orally in soft gelatin capsules in patients with High Grade Glioma (Brain Cancer). It is being conducted at up to 8 centers of the Adult Brain Tumor Consortium.
This study will be conducted in 3 parts:
Part 1. To determine the maximum tolerated dose (MTD) level of oral Terameprocol that can be safely taken orally by patients with high grade glioma on a schedule of 5 consecutive days of dosing every 28 days (a maximum total of 36 patients)
Part 2. To determine the concentrations of Terameprocol in blood (plasma) compared to tumor tissue collected during planned surgical resection in (a total of 6 patients)
Part 3. To determine maximum duration of consecutive days (every 28 days) that the MTD dose level of Terameprocol can be safely taken orally (a maximum total of 24 patients)
Tumor response will also be evaluated as part of this study.
Terameprocol - Intravenous
Results from these Phase I intravenous trials are encouraging and Phase II studies are being planned.
Open-Label Phase I Dose Escalation Study of Intravenous Infusion of Tetra-o-Methyl Nordihydroguaiaretic Acid (EM-1421) in Subjects with Refractory Malignant Tumors. Results from this study were presented at the 2007 American Society of Clinical Oncology meeting and the 2007 American Association for Cancer Research meeting.
Open-Label Phase I/ Phase II Study of Intravenous Infusion of Tetra-o-Methyl Nordihydroguaiaretic Acid (EM-1421) in Subjects with Recurrent High Grade Glioma. This clinical trial was conducted in concert with the New Approaches to Brain Tumor Therapy Consortium (NABTT).
Phase I continuous intravenous infusion study of Terameprocol (EM-1421) in subjects with refractory solid tumors.
Phase I Study of Terameprocol (EM-1421), a Survivin and Cyclin-Dependent-Kinase-1 (Cdc2) Inhibitor, in Patients with Leukemia.
Terameprocol - Intravaginal
Terameprocol has also been evaluated in a Phase I/II clinical pilot study for use as an intravaginal therapy for the treatment of Cervical Intraepithelial Neoplasia (CIN), a viral-induced (human papilloma virus) pre-cancerous change in the cervix. The pilot clinical study demonstrated encouraging results for this indication
Terameprocol - Intratumoral
Erimos has additionally completed a Phase I study of intralesional terameprocol in refractory head and neck cancer.