NuCana Announces Re-Opening of Global Phase III Study of Acelarin Plus Cisplatin in Patients with Biliary Tract Cancer (NuTide:121)

EDINBURGH, U.K., May 05, 2020 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ: NCNA) announced it has re-commenced enrollment of new patients in NuTide:121, its ongoing global Phase III study of Acelarin (NUC-1031) plus cisplatin in patients with biliary tract cancer. The re-opening of NuTide:121 has begun in certain geographies, including Australia, Canada, South Korea, Taiwan, Ukraine and the United Kingdom.  NuCana will work closely with the clinicians involved in NuTide:121 to re-open all of the clinical sites to new patient enrollment as soon as practicable.

“We will continue to monitor the impact of the COVID-19 pandemic, but re-opening this study is important for patients with biliary tract cancer who need treatment,” said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer.  Mr. Griffith added “The COVID-19 pandemic has had a dramatic impact on the global healthcare delivery system and on cancer patient care, and it is vital that the development of new cancer treatments, such as Acelarin, is resumed as quickly as possible.”

NuTide:121 is a global, multi-center, randomized Phase III study of Acelarin, NuCana’s ProTide transformation of gemcitabine, that will enroll up to 828 patients in approximately 120 sites across North America, Europe, Asia and Australia. Patients are being randomized 1:1 and treated with either a combination of Acelarin (725 mg/m²) plus cisplatin (25 mg/m²) or the current standard of care regimen, gemcitabine (1,000 mg/m²) plus cisplatin (25 mg/m²).

About NuCana plc

NuCana is a clinical-stage biopharmaceutical company focused on significantly improving treatment outcomes for cancer patients by applying our ProTide technology to transform some of the most widely prescribed chemotherapy agents, nucleoside analogs, into more effective and safer medicines. While these conventional agents remain part of the standard of care for the treatment of many solid and hematological tumors, their efficacy is limited by cancer cell resistance mechanisms and they are often poorly tolerated. Utilizing our proprietary technology, we are developing new medicines, ProTides, designed to overcome key cancer resistance mechanisms and generate much higher concentrations of anti-cancer metabolites in cancer cells. Our most advanced ProTide candidates, Acelarin and NUC-3373, are new chemical entities derived from the nucleoside analogs gemcitabine and 5-fluorouracil, respectively, two widely used chemotherapy agents. Acelarin is currently being evaluated in four clinical studies, including a Phase III study for patients with biliary tract cancer, a Phase Ib study for patients with biliary tract cancer, a Phase II study for patients with platinum-resistant ovarian cancer and a Phase III study for patients with metastatic pancreatic cancer for which enrollment has been suspended. NUC-3373 is currently in a Phase I study for the potential treatment of a wide range of advanced solid tumors and a Phase Ib study for patients with previously treated metastatic colorectal cancer. Our third ProTide, NUC-7738, is a transformation of a novel nucleoside analog (3’-deoxyadenosine) and is in a Phase I study for patients with advanced solid tumors.