FDAnews
www.fdanews.com/articles/108374-clinical-trial-kicks-off-for-litx-therapy

Clinical Trial Kicks Off for Litx Therapy

July 8, 2008

Light Sciences Oncology has begun treating patients with benign prostatic hyperplasia, or enlargement of the prostate, using Light Infusion Therapy (Litx), a light-activated drug treatment.

The system uses light-emitting diodes to activate injected LS11 (talaporfin sodium) molecules. Once activated, these molecules produce oxygen, which can kill targeted prostate tissues with minimal side effects through vascular closure and apoptosis, or “programmed cell death,” according to Light Sciences.

The company said it plans to conduct a 12-patient, Phase I/II dose-escalation study at four sites in the U.S. as well as a 40-patient, Phase IIa study in Australia this quarter.