Uro Pipeline: Bladder Ca drug-device combination begins second phase Ib trial
Bladder Ca drug-device combination begins second phase Ib trial
TARIS Biomedical has announced the initiation of a second phase Ib clinical trial of its drug-device combination product, TAR-200 (GemRIS [Gemcitabine Releasing Intravesical System]). The trial will focus on patients with nonmuscle-invasive bladder cancer (NMIBC). Researchers will assess whether continuous, local exposure to gemcitabine via TAR-200 is safe and tolerable in patients with intermediate-risk NMIBC. TAR-200 is designed to release gemcitabine continuously into the bladder over 7 days. The open-label study will be conducted at multiple sites in Europe and expects to enroll up to 30 patients who have been diagnosed with NMIBC but have not yet had transurethral resection of bladder tumors.
Injectable agent ablates tumor cells in localized prostate Ca study
Sophiris Bio Inc. recently announced successful biopsy results from all 18 patients enrolled in the phase IIa proof-of-concept study of topsalysin (PRX302) in localized prostate cancer. Topsalysin, an inactivated pore-forming protein that is injected into the prostate, showed the ability to ablate tumor cells in 50% of the patients tested 6 months after treatment. Topsalysin was administered once locally to patients, with no serious adverse effects and no new safety signals reported. The phase IIa study was an open-label study at the University College London. Results of this stage support advancing topsalysin into a phase II study to optimize delivery and confirm dosage, Sophiris Bio said.