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) that 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.
Erimos has conducted multiple phase I clinical trials with terameprocol at various top tier institutions and clinical trial sites in the U.S. Erimos’ primary clinical focus has been the evaluation of terameprocol administered intravenously to patients with various forms of cancer. These trials include:
EM-1421 #101: 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.
EM-1421 #104: Phase I continuous intravenous infusion study of Terameprocol (EM-1421) in subjects with refractory solid tumors.
EM-1421 #105: Phase I Study of Terameprocol (EM-1421), a Survivin and Cyclin-Dependent-Kinase-1 (Cdc2) Inhibitor, in Patients with Leukemia.
EM-1421 #103: 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).
Results from these Phase I intravenous trials are encouraging and Phase II studies are being planned.
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.
Erimos has additionally completed a Phase I study of intralesional terameprocol in refractory head and neck cancer.
Additional information about these trials can be found at www.clinicaltrials.gov. Please use the search term “EM-1421”, or just click here to go straight to the EM-1421 search results.