On May 5, 2020 NuCana plc (NASDAQ: NCNA) reported 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 (Press release, Nucana BioPharmaceuticals, MAY 5, 2020, View Source [SID1234557033]). 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.
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"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).