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FDA grants orphan drug designation to protein kinase CK2 inhibitor for cholangiocarcinoma

The FDA has issued orphan drug designation to CX-4945 for the treatment of cholangiocarcinoma, which will expedite its development, the manufacturer announced.

CX-4945 (Senhwa Biosciences) is a novel, small molecule, protein kinase CK2 inhibitor that “plays an important role in the DNA damage repair mechanisms of cancer cells,” according to a press release. Studies have shown the drug has favorable safety, pharmacokinetic and pharmacodynamic profiles in the treatment of advanced cholangiocarcinoma, for which early detection is difficult. The 5-year survival rate is about 20% and there are limited treatment options.

“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,” Tai-Sen Soong, PhD, CEO of Senhwa Biosciences, said in the press release. “We look forward to seeing the results from our ongoing phase II clinical trial.”

Disclosures: Soong is employed by Senhwa Biosciences.