TAIPEI, Taiwan and SAN DIEGO, Jan. 4, 2017 /PRNewswire/ -- Senhwa Biosciences, Inc. announced today 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.
About Senhwa Biosciences
Senhwa Biosciences identifies and develops innovative therapies that have the potential to fundamentally change the way patients are treated. Our central philosophy is to unearth validated targets or therapies that could significantly improve treatment, but have not yet been properly exploited. As a value-added development company, Senhwa aims to take innovative therapies that could impact the current standard of care and drive them through clinical Proof-of-Concept.
Senhwa has a strong Management Team with proven track records in developing new drugs and targeted agents. Headquartered in Taiwan, but with a vital operational base in San Diego, California, the Senhwa Team is well positioned to oversee the development of their compounds by collaborating with a diverse range of global Investigators and service providers. Clinical trials are ongoing or planned for Australia and the US, and service providers work from their bases in North America, Asia, Australia and Europe. For more information on Senhwa and its programs, please visit www.senhwabio.com.
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SOURCE Senhwa Biosciences, Inc.