Senhwa Biosciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to CX-4945 for the treatment of cholangiocarcinoma.
CX-4945 is a novel small molecule drug that inhibits protein kinase CK2, which plays an important role in the DNA damage repair mechanisms of cancer cells. The study drug has demonstrated favorable safety, pharmacokinetic and pharmacodynamic characteristics in the treatment of advanced cholangiocarcinoma, a disease for which there are limited effective therapies. This cancer is difficult to detect in its early stages, and the survival rate at 5 years is only around 20%.
Orphan Drug Designation is granted by the FDA to novel drugs or biologics that treat rare diseases or conditions affecting fewer than 200,000 patients in the U.S. In the US, orphan drug status carries with it 7 years of marketing exclusivity following FDA approval. This Orphan Drug Designation will expedite the development of CX-4945 in the treatment of cholangiocarcinoma.
"The Orphan Drug Designation represents an important milestone in the development and regulatory strategy for Senhwa's CX-4945 in providing a new treatment option for cholangiocarcinoma. We look forward to seeing the results from our ongoing phase II clinical trial," said Dr. Tai-Sen Soong, CEO of Senhwa Biosciences, Inc.