SciClone Pharmaceuticals, Inc. has submitted a regulatory application to the Chinese State Food and Drug Administration (SFDA) for approval to market the DC Bead, a product for the treatment of liver cancer.
"With the filing of this regulatory application in China, we have taken an important step to broaden our product portfolio for the Chinese market and further our leadership position in this rapidly growing pharmaceutical market," said Friedhelm Blobel, PhD, CEO of SciClone Pharmaceuticals, Inc. "We expect feedback from the SFDA within 90 days on this filing for DC Bead as an embolic agent, and concurrently we expect to initiate a clinical trial using DC Bead with doxorubicin, a specific chemotherapeutic agent to treat liver cancer, in the first half of 2007."
"We congratulate SciClone on the DC Bead regulatory submission," commented Crispin Simon, CEO of Biocompatibles International plc. "China is an important healthcare market and potentially the largest world market for products treating primary liver cancer."
The DC Bead is comprised of microscopic beads, which when administered by catheter into a blood vessel, block the supply of nutrients and blood to a tumour. While the blockage of the blood vessel itself can have an anti-tumour effect, chemotherapeutic agents can be added to the beads for a more targeted anti-tumour effect.
This controlled delivery of an anti-tumour drug concentrates the toxic effect of the drug directly on the tumour and minimizes side effects throughout the rest of the body.
SciClone Pharmaceuticals is a biopharmaceutical company engaged in the development of therapeutics to treat life-threatening diseases. SciClone's lead product Zadaxin is currently being evaluated in late-stage clinical trials for the treatment of malignant melanoma and hepatitis C.