Senhwa Biosciences CX-4945 receives orphan drug status in Cholangiocarcinoma

Release Date: 13-Jan-2017

Senhwa Biosciences Inc. recently declared that US Food and Drug Administration has granted it novel product CX-4945 orphan drug designation for the treatment of patients with 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%.
The FDA's designation of Orphan Status is granted to promote the development of new therapies for rare diseases and disorders. Orphan Status can be applied to products proven safe and effective in treating conditions that affect a relatively small number of patients, and the designation may entitle up to seven years of US marketing exclusivity upon regulatory approval. Companies whose drugs have an orphan designation also receive certain tax credits and are exempted from paying prescription drug user fees normally required of companies submitting products for approval.



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