A Multicenter Phase II Study on Photodynamic Therapy Using Talaporfin Sodium (ME2906) and a Semiconductor Laser (PNL6405CIN) for Intraepithelial Tumors of the Cervix.

ABSTRACT:

Purpose

Conization for high-grade cervical intraepithelial neoplasia (CIN2-3) often harms obstetric outcomes. Photodynamic therapy (PDT) with talaporfin sodium provides a cervix-sparing alternative with short photosensitivity. We investigated the efficacy and safety of talaporfin-PDT for CIN2-3.

Methods

We conducted a prospective, multicenter, single-arm phase II trial (jRCT2041190087) in women ≥ 20 years with biopsy-proven CIN2-3. Patients received talaporfin sodium (40 mg/m²) and 664-nm laser irradiation. Efficacy was evaluated by cytology/histology from weeks 12 to 24; the primary endpoint was complete response (CR) versus an 85% threshold. Safety, HPV status, cervical length, and reproductive outcomes were monitored.

Results

Of 88 enrolled, 79 were trea

SUBMITTER: Murakami H 

PROVIDER: S-EPMC12665164 | biostudies-literature | 2025 Jan-Dec

REPOSITORIES: biostudies-literature