PAPZIMEOS (zopapogene imadenovec-drba) · Precigen, Inc.

No biodistribution and vector shedding studies have been conducted with PAPZIMEOS.

The efficacy of PAPZIMEOS was evaluated in an open-label, single-arm study in adults with recurrent respiratory papillomatosis (PRGN-2012-201; NCT04724980). The study enrolled adults who had histological and clinically diagnosed recurrent respiratory papillomatosis and had 3 or more debulking procedures to remove laryngotracheal papillomas in the 12 months prior to treatment with PAPZIMEOS. A total of 38 patients received subcutaneous injections of PAPZIMEOS on days 1, 15, 43, and 85. Prior to initiation of treatment with PAPZIMEOS (Day 1), patients underwent a standard-of-care surgical debulk...

The most common adverse reactions (incidence ≥5%) were injection site reactions, fatigue, chills, pyrexia, myalgia, nausea, headache, tachycardia, diarrhea, vomiting, and hyperhidrosis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Precigen Inc. at 855-743-6777 and [email protected] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical tria...

None. None. ( 4 )

Injection-site reactions: Injection-site reactions, have been observed. Monitor patients for local site reactions for at least 30 minutes after the initial treatment. ( 5.1 ) Thrombotic events: Thrombotic events may occur following administration of adenoviral vector-based therapies. Monitor patients for signs and symptoms of thrombotic events and treat events according to clinical practice. ( 5.2 ) 5.1 Injection-Site Reactions Injection-site reactions have occurred with PAPZIMEOS injection. Mon...