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Subject ViroMed receives approval for Phase III of VM501 by China FDA
Writer ViroMed
Date 2012/03/30


SEOUL, KOREA, Apr. 2 – ViroMed Co., Ltd. (KOSDAQ: 084990:KS) today announced that it has received an approval from the China State Food and Drug Administration for a Phase III clinical trial of its product VM501, a protein-based therapeutic for chemotherapy-induced thrombocytopenia (CIT)

Granted of the Phase III approval, ViroMed is now one step closer to finding a safe and effective cure for CIT. Successful completion of this Phase III trial will ensure VM501’s safe landing in China, a country expected to be the world’s second largest pharmaceutical market in near future.

It is forecast that there will exist 4.3 million cancer patients and 660,000 thrombocytopenia patients in 2014. Based on these figures, it is estimated that the size of thrombocytopenia market in China would reach approximately $ 441 million USD, and it will continue to grow along with $ 3.1 billion-sized anticancer medicine market.

“This Phase III trial on VM501 will enroll 360 patients at 15 hospitals, and it will be a comparison test between VM501 and Neumega, a pre-existing drug from Wyeth,” said Jong-Mook Kim, the director of Clinical Development Dept. and Strategic Business Dept. of ViroMed. “Collaborations with marketing partners are also in plan for successful commercialization of this product.”

About Chemotherapy-Induced Thrombocytopenia
Patients undergoing chemotherapy often experience thrombocytopenia, a decrease in the number of platelets in the blood. Chemotherapy or radiation treatment destroys not only harmful cancer cells but also the body’s white blood cells, red blood cells, and platelets. While effective treatments for the recovery of white blood cells (Epogen, Aranesp, Procrit) and red blood cells (Neupogen, Neulasta) are available, there is no effective treatment available for the recovery of platelets.

Neumega is the only approved drug for CIT; however, it is limited by its severe side effects. The only other options for cancer patients are also limited – platelet transfusion, which is ineffective after multiple doses and can expose patients to infectious disease, and delaying or reducing the chemotherapy regimen, which may allow the cancer to grow and spread. As such, there is an unmet need for a safe and effective treatment for CIT.

About VM501
VM501 is a reengineered form of the interleukin-11 (IL-11) protein that has been shown to promote the production of platelets in patients affected by CIT. In the Phase II trial held at fourteen hospitals in China, VM501 was compared to Neumega. VM501’s toxicity was shown to be much lower, while its effectiveness was confirmed at only 1/3 the comparable dosage.

About ViroMed
ViroMed Co., Ltd. is a leading biotechnology company located in Seoul, Korea (US office: VM BioPharma). The company has two main areas of focus: DNA/protein-based biopharmaceuticals and phytotherapeutics (botanical drugs/nutraceuticals). ViroMed now has five main products in its pipeline targeting cardiovascular disease: cancer, and immune-related disorder, with clinical trials in the US, Korea, and China. To learn more about the company and its products, visit www.viromed21.com.