MegaPro Biomedical MPB-1523 Clinical Phase II Trial Results Published in International Journals

MegaPro Biomedical MPB-1523 Clinical Phase II Trial Results Published in International Journals

MegaPro Biomedical Co., Ltd. (hereinafter referred to as “MegaPro”, Taiwan OT stock code: 6827) announced the results of the phase II clinical trial of the company’s self-developed MPB-1523 MRI contrast agent – hepatocellular carcinoma. On January 20th, verification has been completed by the Journal of Magnetic Resonance Imaging (abbreviation: JMRI), a prestigious medical journal of radiology, and was issued and published in a recent JMRI journal.

JMRI is one of the most authoritative medical journals in the world. Consequently, the  verification and publishing of the results of the phase II clinical trial of MPB-1523 MRI contrast agent – hepatocellular carcinoma by JMRI is a major milestone in the company’s R&D progress, and it is expected to have a considerable positive impact on the field of cancer treatment.

Dr. Jassy Wang, general manager of MegaPro Biomedical, states that the MPB-1523 nano-iron oxide MRI contrast agent developed by the company based on iron oxide nanoparticle (IOP) technology, can enable nano-iron oxide particles to be quickly consumed by immune cells, clearly marking malignant tumors through the regulation of the hydrophilic and hydrophobic properties of the surface without risking the cause of metal deposition or nephropathy on patients.  Compared with other contrast agents currently on the market, MPB-1523 is more beneficial for the diagnosis and treatment of patients.

According to the report of Global Industry Analysts, Inc., a professional research institution, the global developer market is approximately US$4.9 billion in 2020, with the compound annual growth rate from 2021 to 2027 to be CAGR3.9%. It is estimated that the global developer market will reach US$6.4 billion in 2027.  In MRI examinations, only Gadolinium (Gd) contrast agents can be used at present. Gadolinium is a heavy metal element of the lanthanide series, which may accumulate in the body after an extensive time. It is not recommended for patients with poor renal function (eGFR<30) to use gadolinium contrast agents because it may cause nephrogenic systemic fibrosis (NSF for short). NSF is a disease that causes skin sclerosis throughout the body. This will gradually cause joint contractures and could even lead to death. As there is currently no treatment for NSF,  Taiwan’s Ministry of Health and Welfare also requires that drug product leaflets containing this ingredient be added with a warning that “Administration of gadolinium-containing contrast agents may cause nephrogenic systemic fibrosis”.

MegaPro Biomedical states that a total of 52 subjects with suspected liver cancer cells were enrolled in the second clinical phase of MPB-1523.  In terms of safety tests, the results showed that no serious adverse reactions occurred after the subjects were injected with MPB-1523, as MPB-1523 is an iron-based product that will not cause NSF problems which result from heavy metal residues. In terms of imaging effects, the test results show that after the patient is injected with MPB-1523, the contrast ratio between the lesioned liver cancer cells and normal liver tissue has increased by 50% on the MRI image (T2).  The sensitivity of detecting liver cancer cells has also been significantly enhanced to a high standard of nearly 100%. In addition, the True steady-state Fast Precession Imaging (True FISP) in MRI can clearly detect the subtle vascular invasion in tumor liver cancer cells and provide more information for clinicians to formulate medical strategies. In summary, the results of the phase II clinical trial of MPB-1523 show that it is safe and effective as an MRI contrast agent in the diagnosis of liver cancer cells.

MegaPro further states that since there is currently no MRI contrast agent available for liver cancer patients with poor renal function, the company is currently planning to apply to the US FDA for orphan drug designation for MPB-1523 for liver cancer patients with poor renal function, simultaneously planning phase III clinical trials, and actively negotiating licensing matters with major domestic and international pharmaceutical companies at the same time.