Outstanding performance from MegaPro Biomedical, the contrast agent has received approval by FDA for Phase II of clinical trial

 Home News Outstanding performance from MegaPro Biomedical, the contrast agent has received approval by FDA for Phase II of clinical trial

The MPB-1523 MRI contrast agent developed by “MegaPro Biomedical”, a start-up from ITRI, showed rapid progress! Despite having established for only 3 years, MegaPro Biomedical obtained the approval from the US Food and Drug Administration (FDA) to conduct Phase II of the clinical trial for its contrast agent. The contrast agent has passed the Investigational New Drug application and MegaPro Biomedical will first evaluate the effectiveness of the contrast agent in liver cancer patients. The company expects to complete this clinical evaluation within 2 years.

MRI imaging technology has been gaining popularity in diagnostic and medical imaging and has been rapidly growing recently. In order to increase the image contrast clinically, a contrast agent is often used to increase image resolution. This enables observation of subtle anatomical changes, hence detecting small lesion. The research report has pointed out that the global medical contrast agent market is expected to increase till 5.2 billion USD by 2020 at a compound annual growth rate (CAGR) of 4.2%, and the MRI contrast agent accounts for 15-20% of the medical contrast agents.

The current clinical MRT contrast agents are largely products based on the paramagnetic element Gadolinium (Gd). However, people always have doubts regarding the kidney toxicity and Gd ions deposit in the brain. As a result, EU suggested the termination of some relevant production in July 2017. The MPB-1523 (IOP Injection) from MegaPro Biomedical is a polyethylene glycol modified iron oxide nanoparticle. Since iron is an abundant metal in the human body, its safety is expected to be better than the Gd-based contrast agent.

In addition, with its own crystal form regulation and surface modification technology, MPB-1523 has high magnetic relaxation and high efficiency for macrophage phagocytosis. These properties can be applied to improve image contrast of organs and tissues rich in reticuloendothelial cells such as liver, spleen and lymph nodes, allowing medical personnel to decide whether the tumor is benign or malignant and whether lymphatic metastasis has occurred.

After its spin-off from ITRI in 2015, MegaPro Biomedical dedicate itself to the drug production, non-clinical effectiveness, and safety investigation as well as regulation establishment. After a year of hard work, good progress was achieved for Phase I of clinical trials in 2015 and the products passed the investigational new drug (IND) application from the US Food and Drug Administration (FDA) in 2017. MegaPro Biomedical expects to conduct Phase II of clinical trials in 2018 by evaluating the effectiveness of contrast agent in liver cancer patients, and this clinical evaluation is expected to complete within 2 years.

Contact person for the article: Jassy Wang, CEO of MegaPro Biomedical

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