Triapine

Nanopharmaceutics Inc. Announces End of Patient Recruitment of NCI Phase II Clinical Study with Lutetium Lu 177 Dotatate +/- Triapine for Neuroendocrine Tumors TRON Group Inc (OTCMKTS:TGRP) ALACHUA, FL, UNITED STATES, July 18, 2025 / EINPresswire.com / -- ALACHUA, Fla., July 18, 2025 -- Nanopharmaceutics, Inc., a clinical-stage pharmaceutical development company, today announced completion of patient enrollment in the 94 patient Phase 2 clinical study “A Phase II Randomized Control Trial of Triapine Plus Lutetium Lu 177 Dotatate Versus Lutetium Lu 177 Dotatate Alone for Well-Differentiated Somatostatin Receptor-Positive Neuroendocrine Tumors”. The study (NCI protocol 10558, ClinicalTrials.gov Identifier: NCT05724108) is sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health, conducted by NCI funded Experimental Therapeutics Clinical Trials Network (ETCTN) with the Ohio State University Comprehensive Cancer Center as the lead institution. The randomized phase 2 trial is evaluating (PRIMARY OBJECTIVE) the overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of combination Triapine ® + lutetium Lu 177 dotatate (treatment arm 1) versus standard of care lutetium Lu 177 dotatate alone (treatment arm 2) and (SECONDARY OBJECTIVE) to evaluate progression-free survival (PFS) between the two treatment arms (combination arm 1 versus standard of care arm 2). This phase II trial compares the effect of adding Triapine ® to lutetium Lu 177 dotatate versus lutetium Lu 177 dotatate alone (standard therapy) in shrinking tumors or slowing tumor growth in patients with neuroendocrine tumors that have spread from where they first started (primary site) to other places in the body (metastatic). Triapine ® may stop the growth of tumor cells by blocking some of the enzymes needed for deoxyribonucleic acid synthesis and cell growth. Lutetium Lu 177 dotatate is a radioactive drug. It binds to a protein called somatostatin receptor, which is found on some neuroendocrine tumor cells. Lutetium Lu 177 dotatate builds up in these cells and gives off radiation that may kill them. It is a type of radioconjugate and a type of somatostatin analog. This study tests whether adding Triapine ® improves shrinking tumors or slowing tumor growth in patients with metastatic neuroendocrine tumors than the standard therapy of lutetium Lu 177 dotatate alone. 94 patients were enrolled in the study, which was performed under a Cooperative Research and Development Agreement (CRADA) between NCI and Nanopharmaceutics. The phase II trial passed the pre-planned interim safety review and interim futility assessment and is awaiting primary endpoint maturity. About Triapine ® Triapine ® is s synthetic heterocyclic carboxaldehyde thiosemicarbazone with potential antineoplastic activity being studied in the treatment of cancer. It is a type of ribonucleotide reductase inhibitor. Also called 3-aminopyridine-2-carboxaldehyde thiosemicarbazone and 3-AP, Triapine ® inhibits the enzyme ribonucleotide reductase, resulting in the inhibition of the conversion of ribonucleoside diphosphates to deoxyribonucleotides necessary for DNA synthesis. 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 is focused on formulation development aimed at improving drug absorption and stability. Nanopharmaceutics is a subsidiary of TRON Group Inc. (OTC:TGRP). James D. Talton, Ph.D. Nanopharmaceutics, Inc. +1 386-401-6304 email us here Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

ALACHUA, Fla. and CHICAGO, May 14, 2024 /PRNewswire/ -- Nanopharmaceutics, Inc. (OTC:TGRP), a clinical-stage pharmaceutical development company, announced the initiation of a Phase I clinical study with the Robert H. Lurie Comprehensive Cancer Center of Northwestern University "A Phase 1 Adaptive Dose Escalation With Dose Expansion Study of Triapine in Combination With Temozolomide (TMZ) for Patients With Recurrent Glioblastoma" (ClinicalTrials.gov Identifier: NCT06410248). The primary objective of this phase 1 study will be to determine the recommended phase 2 dose (RP2D) for Triapine® in combination with temozolomide (TMZ). Secondary objectives include evaluation of the safety profile of Triapine® in combination with temozolomide (TMZ), progression-free survival (PFS), overall survival (OS), overall response rate (ORR) per RANO criteria, and quality of life per FACT-Br. The study will recruit 40-45 patients with an established diagnosis of recurrent glioblastoma, and there will be an exploratory arm to investigate drug delivery into brain tumor tissue and target engagement in a cohort who are surgical candidates for re-resection of recurrent glioblastoma. Funding for the study is provided by BrainUp. Oral Triapine® has been shown to be safe, tolerable, and convenient in multiple clinical studies. Ribonucleotide Reductase (RNR) Regulatory Subunit 2 (RRM2) targeting with Triapine® may overcome chemoresistance and improve the clinical efficacy of TMZ therapy. Preliminary research from Dr. Atique Ahmed's lab at Northwestern University has uncovered a critical factor that helps glioblastoma, an aggressive brain cancer, resist chemotherapy treatment. About the Robert H. Lurie Comprehensive Cancer Center of Northwestern University The Robert H. Lurie Comprehensive Cancer Center of Northwestern University is a National Cancer Institute-designated Comprehensive Cancer Center located on Northwestern Memorial Hospital's downtown medical campus in the Streeterville neighborhood of Chicago, Illinois, United States. About BrainUp BrainUp is a nonprofit founded by Dan & Meg Kresach of Frankfort, Illinois. They founded BrainUp after their only child Olivia, was diagnosed 10 years ago with a Glioblastoma at the age of 22 years old. She died on April 19, 2014. The Kresachs formed BrainUp to fund brain cancer research. They have an annual run/walk to raise money for brain cancer research. They have funded over 1.2 million dollars supporting brain cancer research and trials at Chicago healthcare institutions. BrainUp is the financial supporter of Karan Dixit, M.D. (PI) and Atique Ahmed, Ph.D of Northwestern University Chicago, Illinois. To learn more about BrainUp, visit brainup.ngo 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. Leveraging its expertise in nanoparticle and fine-particle formulations, which can specifically be used to improve hard-to-deliver BCS category II and IV drugs, Nanopharmaceutics is focused on formulation development aimed at improving drug absorption and stability. Contact: Nanopharmaceutics, Inc. (OTC: TGRP) James D. Talton, Ph.D. President and Chief Executive Officer 386-401-6304 SOURCE Nanopharmaceutics, Inc.