The MPB-1523 MRI imaging agent developed by MegaPro Biomedical, a new biotech company from the Institute of Industrial Technology, has made rapid progress! Within three years of its establishment, it has passed the US Food and Drug Administration (FDA) Human Clinical Trial Examination (IND) and has been approved to proceed to the second phase of clinical trials. MegaPro Biomedical will first evaluate the imaging effect of liver cancer patients, and it is expected to complete this clinical evaluation within 2 years.
MRI imaging technology has become more and more popular in imaging diagnostic medicine, and it has been developing rapidly in recent years. In clinical practice, in order to increase the contrast of images, imaging agents are often used to improve the resolution of the images to detect subtle anatomical changes and detect tiny lesions. According to research reports, the global medical contrast media market is expected to increase to 4.2 billion US dollars at a rate of 4.2% annual compound growth rate (CAGR) by 2020, of which the proportion of MRI contrast media accounts for about 15-20% of all medical contrast media.
At present, most of the MRI imaging agents in clinical use are paramagnetic elements related to Gadolinium (Gd), but Gd ions have always been suspected of kidney toxicity and brain accumulation, which led to the EU's recommendation in July 2017 to stop using several related products. The MPB-1523 (IOP Injection) from MegaPro Biomedical is a polyethylene glycol modified product of iron oxide nanoparticles. Iron is a rich metal in the human body, so it is expected that it will be better than Gd type developers in terms of safety.
In addition, with the crystal form control and surface modification technology possessed by MegaPro Biomedical, MPB-1523 is high in nuclear magnetic relaxation and possesses high efficiency macrophage phagocytosis qualities. This feature can be used to visualize tissues and organs rich in reticuloendothelial cells, such as the liver, spleen, and lymph nodes for medical personnel to judge whether the patient is a benign or malignant tumor and whether lymphatic metastasis occurs.
Since its spinoff from the Institute of Industrial Technology and Research in 2015, after a year of efforts in drug manufacturing, non-clinical effectiveness and safety discussion and establishment of regulations, MegaPro Biomedical has made good progress in the first phase of clinical trials in 2015, and at the end of 2017 , it passed the US Food and Drug Administration (FDA) human clinical trial review (IND). The clinical phase two trial is expected to be conducted in 2018. The development effect of liver cancer patients will first be evaluated.
Contact person for press release: Dr. Jassy Wang, General Manager of MegaPro Biomedical
e-mail:
Phone:03-5910482