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NuCana's Biliary Tract Cancer Candidate Gets Orphan Drug Tag

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NuCana plc (NCNA - Free Report) 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 (LLY - Free Report) 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 industry’s increase of 1.2%.

Acelarin is the most advanced product candidate in NuCana’s portfolio. It is a ProTide transformation of Gemzar. The ProTide technology is a prodrug approach used in molecular biology and drug design.

Apart from this combination study, Acelarin is being evaluated in a phase II program for treating patients with platinum-resistant ovarian cancer. The company plans to report interim results from the study, later in 2019. The candidate is also being investigated in a phase III analysis for pancreatic cancer.

Zacks Rank & Stocks to Consider

NuCana currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the healthcare sector include Acorda Therapeutics, Inc. (ACOR - Free Report) and Repligen Corporation (RGEN - Free Report) , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Acorda’s loss per share estimates have been narrowed 6.5% for 2019 and 6.9% for 2020 over the past 60 days.

Repligen’s earnings estimates have been revised 12% upward for 2019 and 12% for 2020 over the past 60 days. The stock has surged 44.3% year to date.

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