Lutetium Dotatate LU-177

Phase I Study with Triapine + Lutetium Lu 177 Dotatate in patients with progressive well-differentiated gastroenteropancreatic neuroendocrine tumors (GEP-NETs) TRON Group Inc. (OTCMKTS:TGRP) ALACHUA, FL, UNITED STATES, September 10, 2025 / EINPresswire.com / -- Nanopharmaceutics, Inc., a clinical-stage pharmaceutical development company, today announced a presentation of the National Cancer Institute (NCI) sponsored Phase I Study 10388 (NCT04234568) “Testing the Addition of an Anti-cancer Drug, Triapine , to the Usual Radiation-Based Treatment (Lutetium Lu 177 Dotatate) for Neuroendocrine Tumors” in an oral presentation at the European Society for Medical Oncology (ESMO) Congress, held from October 17-21, 2025 in Berlin, Germany. The data will be presented on the October 20th Mini oral session: NETs and endocrine tumours “1709MO - Multi-center NCI-sponsored phase 1 study of triapine in combination with 177Lu-dotatate in patients with well-differentiated gastroenteropancreatic neuroendocrine tumours (GEP-NETs)” at the 2025 European Society of Medical Oncology (ESMO) Congress by Aman Chauhan, MD, Associate Professor of Medical Oncology, Leader of Neuroendocrine Tumor Program and Co-Director of Theranostics Program, University of Miami Sylvester Comprehensive Cancer Center. This study was sponsored by the National Cancer Institute (NCI), part of National Institutes of Health, and conducted by the NCI funded Experimental Therapeutics Clinical Trials Network (ECTCN). The end of patient recruitment was recently announced for a NCI-sponsored randomized phase 2 trial 10558 (NCT05724108) “Testing the Effectiveness of an Anti-cancer Drug, Triapine ® , When Used With Targeted Radiation-based Treatment (Lutetium Lu 177 Dotatate), Compared to Lutetium Lu 177 Dotatate Alone for Metastatic Neuroendocrine Tumors” currently underway at 14 sites across the United States. This 94 patient phase II trial recently passed the pre-planned interim safety review and interim futility assessment and is awaiting primary endpoint maturity. Both studies are being performed under a Cooperative Research and Development Agreement (CRADA) between NCI and Nanopharmaceutics and conducted by ECTCN. 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 Nanopharmaceutics, Inc. +1 386-401-6304 info@nanopharmaceutics.com 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.

CHENGDU, China, Sept. 10, 2025 /PRNewswire/ -- August 22, 2025, Mednovo Group Co., Ltd. ("Mednovo") announced that the first patient has been successfully dosed in its Phase III clinical trial of Lutetium [177Lu] Oxodotreotide Injection, a Class 3 targeted radiotherapeutic drug. As the exclusive clinical supply and manufacturing partner, C-Ray Therapeutics delivered end-to-end support for this milestone, including technology transfer, clinical batch production, quality release, and logistics. Leveraging China's first fully automated radiopharmaceutical production line built to global cGMP standards, C-Ray ensured the trial began on schedule. The company's philosophy—high quality, cost efficiency, and first-time-right production—underpinned its execution. Lutetium [177Lu] Oxodotreotide Injection targets somatostatin receptors and is primarily indicated for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Entering Phase III represents a pivotal step for the program, requiring production processes and quality controls that meet near-commercial standards. C-Ray's cGMP manufacturing capabilities and globally compliant quality system provided a solid foundation for reliable clinical supply. Since the project was accepted by China's Center for Drug Evaluation (CDE), C-Ray has worked closely with Mednovo's clinical schedule, efficiently completing raw material release, technology transfer, production, testing, and nationwide logistics to ensure timely first-patient dosing. Looking ahead, C-Ray will continue supporting Mednovo's multi-center trial with its patented, internationally compliant cold-chain packaging for radiopharmaceuticals and its integrated land-air logistics network. A Mednovo representative commented that C-Ray Therapeutics is a vital partner for their Lutetium [177Lu] Oxodotreotide Injection program. Their professional expertise, efficiency, and cGMP-compliant automated production line ensured the stable, high-quality supply of clinical materials for this Phase III trial. They look forward to advancing this program together. To date, C-Ray has successfully supported more than 50 CRDMO (Contract Research, Development, and Manufacturing Organization) projects across the full lifecycle—from early-stage R&D to clinical and commercial supply. With a 28,000 m² cGMP-compliant R&D and manufacturing base and a global radionuclide supply chain, C-Ray continues to deliver high-quality, efficient, and fully compliant solutions for pharmaceutical partners worldwide. About Mednovo Mednovo was established on January 1, 2011, as a diversified large-scale group company integrating R&D, production, sales, and investment& financing, with a dedicated focus on the healthcare industry. Since 2021, the group has adopted a strategy of "in-house R&D + acquisitions + equity investments" to establish multiple medical device projects, diversifying its portfolio and realizing its grand technological strategic vision for the industry. Starting with minimally invasive interventional sales, Mednovo has built a nationwide sales and service network. The group adheres to a dual approach of independent R&D and technology introduction, initially establishing an R&D, production, and operational system with internationally advanced standards. With a deep focus on global markets, the group actively seeks cutting-edge international technologies that address unmet market needs. Through an innovative industry collaboration model of "financial investment + sales partnership," Mednovo works hand-in-hand with leading players, using investment to drive projects and projects to fuel development. Currently, the group holds 39 medical device registration certificates, covering multiple specialized fields such as drug-coated balloon products, microwave ablation therapy products, cryoablation therapy products, tumor interventional embolization therapy products, neurointerventional products, and assisted reproductive consumables. Additionally, the group is expanding into the nuclear medicine sector, with several innovative nuclear medicine products under development. This has formed a dual-driven development strategy of "devices + nuclear medicine," dedicated to advancing the healthcare industry through innovative technologies. About C-Ray Therapeutics C-Ray Therapeutics is a leading radiopharmaceutical CRDMO in China, providing one-stop solutions from process development and IND application to clinical supply and commercial manufacturing. The company operates a 28,000 m² world-class cGMP production base and GLP-like pre-clinical research facilities. To date, C-Ray has delivered more than 50 CRDMO projects, among these, 6 projects are at the IND and IND-enabling stages, 7 have advanced to investigator-initiated trials (IIT), and 2 have entered the clinical supply phase. The company also plays an active role in developing and integrating the global radionuclide supply chain, including securing scarce isotopes such as Actinium-225. To date, C-Ray has successfully supported the development of 14 Ac-225–based labeling programs. Through its industry-academia-research-application platform, C-Ray aims to drive innovation, overcome technical barriers, and accelerate the clinical translation of diagnostic and therapeutic radiopharmaceutical solutions, positioning itself as a benchmark enterprise in global radiopharmaceutical development. SOURCE C Ray Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED