Nanopharmaceutics Announces Initiation of Clinical Study of Oral Tetrathiomolybdate Capsules in Breast Cancer Patients
Nanopharmaceutics Announces Initiation of Phase 1b / 2 Clinical Study of Oral Tetrathiomolybdate Capsules in Triple Negative Breast Cancer Patients
TRON Pharmaceuticals, Inc. (OTCMKTS:TGRP)
ALACHUA, FL, UNITED STATES, October 11, 2024 /EINPresswire.com/ -- Nanopharmaceutics, Inc., a clinical-stage pharmaceutical development company, announced the initiation of a Phase 1b / 2 clinical study with Dartmouth Health’s Dartmouth Hitchcock Medical "Novel Targeting of the Microenvironment to Decrease Metastatic Recurrence of High-Risk TNBC: A Randomized Phase II Study of Tetrathiomolybdate (TM) plus capecitabine in patients with breast cancer at high risk of recurrence" (ClinicalTrials.gov Identifier: NCT06134375). The primary objective of the phase 1b study will be to establish the safety of the combination of adjuvant tetrathiomolybdate with capecitabine and pembrolizumab administered to patients with triple negative breast cancer after completion of neoadjuvant chemotherapy and with a non-pCR (RCB 2, 3) after standard surgery. The primary objective of the phase 2 study will be relapse-free survival (DRFS) between TM and capecitabine versus capecitabine +/- pembrolizumab. The Principal Investigator is Linda Vahdat, MD MBA, Chief of Medical Oncology and interim Chief of Hematology an Deputy Cancer Center Director at Dartmouth Cancer Center and the study will recruit 204 patients.Ammonium Tetrathiomolybdate (TM) lowers copper levels in the body. Tetrathiomolybdate has been tested in 22 clinical studies as ammonium tetrathiomolybdate and bis-choline tetrathiomolybdate. The pharmacological class for TM is that of an oral drug which lowers copper levels in the body. TM forms a tripartite complex with copper and protein, eventually cleared primarily by the liver with excretion into the bile. The target indication for usage of TM in this study is in cancer as an anti-metastasis agent. Robust pre-clinical and clinical data in breast cancer suggest that reprogramming of the tumor microenvironment leading to a non-permissive environment for metastases occurs.
About Nanopharmaceutics, Inc.
Nanopharmaceutics, Inc. is a clinical-stage specialty pharmaceutical company developing oral, topical, and injectable products for cancer, central nervous system (CNS) disorders, and infectious diseases. Nanopharmaceutics, Inc. is a wholly-owned subsidiary of TRON Pharmaceuticals, Inc. (OTC:TGRP)
About Dartmouth Hitchcock Medical Center
Dartmouth Hitchcock Medical Center is the state's only academic medical center and the only Level I Adult and Level II Pediatric Trauma Center in New Hampshire. The Dartmouth Cancer Center is 1 of 57 NCI designated Comprehensive Cancer Centers (CCC) and the only CCC in northern New England.
James D Talton
Nanopharmaceutics, Inc.
+1 386-401-6304
info@nanopharmaceutics.com
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