PIPELINE
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:
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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)
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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)
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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)
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Tumor response will also be evaluated as part of this study.
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Terameprocol - Intravenous
Results from these Phase I intravenous trials are encouraging and Phase II studies are being planned.
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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.
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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).
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EM-1421 #104
Phase I continuous intravenous infusion study of Terameprocol (EM-1421) in subjects with refractory solid tumors.
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EM1421 #105
Phase I Study of Terameprocol (EM-1421), a Survivin and Cyclin-Dependent-Kinase-1 (Cdc2) Inhibitor, in Patients with Leukemia.
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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.
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