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NUC-3373 (fosifloxuridine nafalbenamide), a new chemical entity derived from the nucleoside analog 5-fluorouracil, continues rapid development with multiple data readouts and dosing of first patients in Phase 3 colorectal cancer study.
Lead Product(s): Fosifloxuridine Nafalbenamide,Calcium Folinate
Therapeutic Area: Oncology Product Name: NUC-3373
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 02, 2022
Details:
10 patient out of 37 case studies highlighted NUC-3373’s ability to stabilize disease and achieve prolonged durations of progression-free survival. Many patients achieved longer progression-free survival on NUC-3373 than they had on their prior line of therapy.
Lead Product(s): Fosifloxuridine Nafalbenamide,Calcium Folinate
Therapeutic Area: Oncology Product Name: NUC-3373
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 15, 2021
Details:
Encouraging interim data had previously been reported and the final data confirm the high objective response rate and favorable safety profile of Acelarin plus cisplatin in this patient population.
Lead Product(s): Acelarin,Cisplatin
Therapeutic Area: Oncology Product Name: NUC-1031
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 30, 2020
Details:
NuTide:121 is a global randomized Phase III study of Acelarin that will enroll up to 828 patients in approximately 120 sites across North America, Europe, Asia and Australia.
Lead Product(s): Acelarin,Cisplatin
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 05, 2020
Details:
The study compared a 500mg/m2 dose of Acelarin versus a 750mg/m2 dose of Acelarin in patients who were heavily pre-treated (at least 3 prior lines of chemotherapy).
Lead Product(s): Acelarin
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 10, 2020
Details:
Acelarin, in combination with cisplatin, is currently being evaluated in a global Phase III study (NuTide:121) for the first-line treatment of patients with biliary tract cancer.
Lead Product(s): Acelarin
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 05, 2020
Details:
The enrollment of patients in NuTide:121 follows U.S. Food and Drug Administration (FDA) clearance of the company's investigational new drug application (IND) for Acelarin.
Lead Product(s): Acelarin,Cisplatin
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 27, 2020
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