BoomRay's Radioactive Diagnostic New Drug [18F]BF3-BPA Injection Completes First Subject Enrollment in Phase I Clinical Trial
22 Apr 2024
Phase 1
On April 20, 2024, BoomRay Pharmaceutical Co., Ltd. (“BoomRay”) announced that the phase I clinical trial of its positron emission tomography (PET) tracer [18F]BF3-BPA injection for the diagnosis of primary and metastatic brain tumors has completed the enrollment of the first subject.
The phase I clinical trial is conducted by the Department of Nuclear Medicine, Zhongshan Hospital, Fudan University. The principal investigators are Dr. Hongcheng Shi, Chief Physician of Nuclear Medicine, and Dr. Xuening Li, Chief Pharmacist of Phase I Pharmacology Lab. The main objective of this clinical trial is to evaluate the pharmacokinetic characteristics, biodistribution, and safety of [18F]BF3-BPA injection in the human body. It is expected to enroll 10 subjects.
[18F]BF3-BPA is a novel amino acid analog molecule designed for PET imaging to diagnose primary and metastatic brain tumors. [18F]BF3-BPA specifically accumulates in tumor tissues with low uptake in normal brain tissues. The significant contrast between tumor lesions and normal brain tissues gives [18F]BF3-BPA a high tumor-to-brain ratio (T/B). It is superior in diagnosing brain tumors compared to the currently used glucose PET tracers.
"The completion of first subject enrollment indicates this program is progressing as planned,” said Longbin Ye, Senior Clinical Medical Director of BoomRay. "Our team will continue working closely together and strictly follow the trial protocol and GCP requirements to obtain high-quality, reliable clinical data that can lay a solid foundation for the further R&D of this innovative PET tracer."
“The kickoff of this phase I trial is an important milestone for BoomRay's R&D pipeline,” said Dr. Bo Shan, CEO of BoomRay. "The company will continue to focus on innovation and develop more safe and effective radioactive targeted drugs to serve clinical needs. The approval of this product following successful clinical trials will bring new diagnostic and therapeutic options to brain tumor patients. "
About BoomRay
BoomRay Pharmaceuticals Co., Ltd. is a clinical-stage biotech focusing on delivering innovative radioactive targeted drugs (RTDs) for precise tumor diagnosis and treatment. Currently, BoomRay has multiple clinical-stage RTD products. In 2022, BoomRay completed nearly RMB300 million in Series A financing. At present, BoomRay has a number of proprietary diagnostic and therapeutic radionuclide drugs under research, with independent intellectual property rights. Headquartered in Suzhou, BoomRay has also established business departments for new drug discovery, clinical translations, and registration in Beijing and Shanghai. The company has a management team led by overseas high-pro with rich backgrounds in the nuclear medicine industry and experience in drug design and translation. Relying on the technology platforms and basic research infrastructures of Peking University, and cooperating with many hospitals, BoomRay is committed to building itself into a first-class nuclear medicine company with original innovation and highly efficient industrial translation capabilities.
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