MegaPro MPB-1523, a MRI contrast agent for focal liver lesion, just completed its End of Phase 2 (EOP2) meeting with U.S. FDA and will aim to the IND of Phase III clinical trials. MegaPro Biomedical Co., Ltd. (hereinafter referred to as "MegaPro", Taiwan OTC Stock Code: 6827) announced January 2024 that the company's nano medicine, MPB-1523, a nano-iron oxide MRI contrast agent has completed the end-of-phase 2 meeting of the U.S. FDA and received the official meeting minutes, according to which the company will submit IND filing to FDA for its phase 3 clinical trials of focal liver lesion the Q2/2024. MegaPro has fully discussed and exchanged opinions with the US FDA on clinical, preclinical, pharmaco-dynamic and chemical manufacturing control (CMC) issues at the EOP2 meeting at December/ 2023. The clinical trial protocol will be modified with additional materials/data will be submitted based on the clinical design recommendations provided by the US FDA. Applications to the FDA for global phase III clinical trials are expected to take place in the second quarter of 2024. Megapro states that the diagnosis of focal liver lesion by contrast-enhanced MRI remained an important clinical needs globally. The incidence rate of focal liver lesion is continuously increasing, not only due to liver cirrhosis and hepatitis, but also due to alcohol consumption, metabolic syndromes and colorectal cancer. Contrast enhanced MRI is the gold standard, after B-mode ultrasound (US) and computed tomography (CT), because of its highest sensitivity. If doubt remains, the options are biopsy or surgical excision. Therefore, MegaPro plans to further develop the MPB1523, nano-iron oxide MRI contrast agent, for its phase 3 study. The company will submit the phase 3 study to FDA and plan a multiple region clinical trial (MRCT, USA, China and Taiwan) to accelerate the launch of MPB1523 products, which will benefit the clinical needs of focal liver lesion patient population. MegaPro possess a unique nanoparticle technology platform and has developed more than 5 product pipelines accordingly, MPB1523 is the first and most advanced product pipeline to its phase 3 . Through the exclusive patented surface modification of nanoparticles, the hydrophilic and hydrophobic surface coating properties are well balanced. It allowed MPB1523 can be well phygocytosed by immune cells, and quickly enter into liver. Therefore MPB1523 can provide a better contrast enhancement thus to clearly mark malignant tumors. Compared with other MRI contrast agents containg heavy metal Gd, heavy metal deposition and nephropathy are very common concerns especially for the kidney impairment patients. MPB1523 provides high sensitivity and better safety profile among the diagnosis tools for focal liver lesion patients. MPB1523, a MRI contrast agent for focal liver lesion, is making the fastest progress among the company's product pipeline in clinical trials stage, having completed the FDA's EOP2 meeting. The proposed Phase III clinical trial design, in addition to primarily targeting hepatocellular carcinoma, will also extend the indications to the diagnosis of metastatic liver malignant tumors. It is expected that a safer and more sensitive contrast agent for malignant liver tumor is very needed for those patient population. The results of the Phase II clinical trial of MPB1523 were published in the Journal of Magnetic Resonance Imaging (JMRI). The contents in the published data includes: (1) In terms of safety monitoring, no serious adverse reactions occurred and AE percentage are very low; (2) In terms of imaging contrasteffect, the clinical results show that the sensitivity of detecting liver cancer cells can be significantly enhanced to reach a high level of 96%. Phase 2 clinical trial of MPB1523 show that it is safe and effective as an MRI contrast agent in the diagnosis of liver cancer cells.
File: MegaPro MPB-1523, a MRI contrast agent for focal liver lesion, just completed its End of Phase 2 (EOP2) meeting with U.S. FDA and will aim to the IND of Phase III clinical trials. 17/01/2024 Dissemination of a Financial Press Release, transmitted by EQS News. |
