Light Sciences Oncology, Inc. (LSO) today announced that it has begun treatment of patients with benign prostatic hyperplasia (BPH), or enlargement of the prostate, using Light Infusion Therapy(TM) (Litx(TM)), an innovative light-activated drug treatment under development. LSO plans to conduct a 12-patient, Phase I/I I dose-escalation study at four sites in the United States as well as a 40-patient, Phase IIa study in Australia, expected to begin during the current quarter.
“Treating patients with this serious quality-of-life problem is an important milestone for our Litx technology,” said Llew Keltner, M.D., Ph.D., President and Chief Executive Officer of LSO. “We plan to continue to demonstrate the broader applicability of Litx beyond oncology.” LSO currently is conducting Phase III clinical studies of Litx in patients with hepatoma (primary liver cancer) and metastatic colorectal cancer and expects to initiate a Phase III clinical study in glioma in the second half of 2008.
BPH is a common result of aging and is estimated to occur in more than 14 million American men. BPH rarely causes symptoms before age 40, but more than half of men in their sixties and as many as 90 percent in their seventies and eighties have some symptoms of BPH, which typically include painful and frequent urination caused by the enlarged prostate’s reduction of urine flow through the urethra. Early stage treatment is critical, because severe BPH can cause serious problems over time, such as urinary tract infections, bladder stones, incontinence, and eventually untreatable bladder or kidney damage.
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 proprietary 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. The short, single outpatient treatment is designed to effectively re-establish and maintain an unobstructed urine flow, relieving BPH symptoms.
Oncology, L. (2008, July 8). “Light Sciences Oncology Begins Clinical Trials Of Litx Therapy In Patients With Enlarged Prostate.” Medical News Today.