NuCana's Biliary Tract Cancer Candidate Gets Orphan Drug Tag
Zacks Investment Research | Jun 12, 2019 10:26PM ET
NuCana plc (NASDAQ:NCNA) announced that the FDA has granted an orphan drug designation to its pipeline candidate, Acelarin, for the treatment of patients with biliary tract cancer, better known as cholangiocarcinoma.
A phase Ib study is evaluating Acelarin in combination with chemotherapy drug, cisplatin, compared with the combination of Eli Lilly’s (NYSE:LLY) Gemzar (gemcitabine) plus cisplatin, which is the current standard of care treatment. Data from this study showed that the combo of Acelarin + cisplatin nearly doubled the expected response rate as compared to the standard of care. Moreover, several patients in the Acelarin + cisplatin arm achieved significant reductions in the volume of their tumor as well as experienced tumor shrinkage over time.
Per the company, the Acelarin combo is a notable advancement for treating patients with biliary tract cancer, a disease with an unmet medical need. NuCana plans to begin a global phase III study later in 2019 on the Acelarin combo as a front-line treatment for patients with advanced biliary tract cancer.
Notably, the orphan drug designation is granted to drugs capable of treating rare diseases that affect less than 200,000 people in the United States. This designation also makes the company entitled to certain other benefits including the tax credits related to clinical trial expenses and an exemption from the FDA user fee.
Shares NuCana have declined 18.1% so far this year against the Original post
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