Press release content from Globe Newswire. The AP news staff was not involved in its creation.
Steba Biotech Treats First Patient in Pivotal ENLIGHTED Study of Padeliporfin ImPACT in Low .
Steba biotechApril 20, 2021 GMT
Pivotal Phase 3 trial recruiting 100 patients, and examining complete response of tumors as the primary endpoint.
Consists of induction and maintenance phases, with follow up 12 months post treatment
The activation of ENLIGHTED marks a significant milestone for Steba’s ambitious development program
LUXEMBOURG, April 20, 2021 (GLOBE NEWSWIRE) Steba Biotech, the pioneering Immune Photo Activate Cancer Treatment (ImPACT) specialist, today announces the treatment of the first patient in ENLIGHTED, its pivotal Phase 3 trial of Padeliporfin ImPACT for the treatment of Low Grade Upper Tract Urothelial Cancer (UTUC).
Press release content from Globe Newswire. The AP news staff was not involved in its creation.
Steba Biotech receives FDA Orphan Drug Designation for Padeliporfin ImPACT in Upper Tract .
Steba biotechMarch 8, 2021 GMT
Designation confers advantages including marketing exclusivity and tax credits
Padeliporfin ImPACT pivotal Phase 3 trial in UTUC to start end Q1 2021
LUXEMBOURG, March 08, 2021 (GLOBE NEWSWIRE) Steba Biotech, the IMmune Photo Activate Cancer Treatment (IMPACT) specialist today announces the U.S. Food and Drug Administration granted Orphan Drug Designation (ODD) to Padeliporfin ImPACT for the treatment of adult patients with Upper Tract Urothelial Cancer (UTUC).
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The FDA has already given the green light to the Investigational New Drug (IND) application, allowing initiation of the pivotal Phase 3 clinical trial of Padeliporfin ImPACT in patients with low-grade UTUC, which is expected to begin enrollment later this month. Padeliporfin ImPACT has