• It has no long-term side effects when used properly.
• It is less invasive than surgery.
• It can be targeted very precisely.
• Unlike radiation, it can be repeated many times at the same site if needed. There is little or no scarring after the site heals.

A Phase I/II project sponsored by Light Sciences Oncology (Bellvue, WA), the study aims to determine safety and efficacy of the photodynamic therapy approach to this common cause of urinary obstruction in aging men.   A related device is currently available commercially in Asia for treatment of liver tumors.

In July, the first patients were treated in a Phase I/II dose-escalation study to take place at four sites in the United States, including USRF. A follow-on 40-patient study (Phase IIa) will begin in Australia later this year.

Litx uses light-emitting diodes (LEDs) to activate LS11 (talaporfin sodium) molecules. Once activated, these molecules cause the production of singlet oxygen, which can kill target tissues with minimal side effects through vascular closure and apoptosis, or "programmed cell death." The single-use, disposable Litx device contains a tiny array of LEDs.

In the Litx BPH application, a modified standard urethral catheter positions the light-emitting LED array precisely within the prostate. After systemic injection of LS11, the LEDs are turned on, and activation of the drug occurs locally within the prostate. When the short treatment is complete, the LED-containing catheter is removed and thrown away. The goal of the therapy is to kill prostate tissue via apoptosis within a highly localized zone in the prostate, without causing inflammation, and to re-establish and maintain an unobstructed urine flow, relieving BPH symptoms.

The mechanism of action of photodynamic therapy is shown in this video.

This trial is registered at ClinicalTrials.gov, a service of the National Institutes of Health.

For further information about this trial, please contact:
Malu Macairan, M.D.
p: 310-838-6347
mmacairan@usrf.org