Light Sciences Oncology, Inc. (LSO) today announced the treatment of the first patients in a Phase 2 clinical trial of its innovative targeted drug treatment Aptocine(TM) (talaporfin sodium) in Benign Prostatic Hyperplasia (BPH). The Phase 2 trial expands the Aptocine BPH development program on the basis of a Phase 1 study at escalating light doses. In the open-label Phase 2 trial, Aptocine is being tested for safety and efficacy in 40 patients with lower urinary tract symptoms (LUTS) due to BPH. Aptocine is also in two Phase 3 clinical trials for solid tumors in the liver as well as preclinical development for prostate cancer.
"Beyond Aptocine's late-stage development as a revolutionary treatment for solid tumors, we believe Aptocine also presents a new paradigm in treating benign neoplasms such as BPH," said LSO's President and CEO, Llew Keltner, M.D., Ph.D. "The Phase 2 BPH trial greatly widens the potential of Aptocine as a uniquely safe and effective targeted therapy."
Benign prostatic hyperplasia (BPH) is a nonmalignant enlargement of the prostate. The most common clinical manifestation of BPH is lower urinary tract symptoms, including urinary frequency, urgency, nocturia, decreased and intermittent force of urine stream and sensation of incomplete bladder emptying. BPH is a disease of the aging male population with a dramatic increase in incidence after the age of 50 years. The American Urological Association estimates that BPH will affect approximately 50 percent of men between the ages of 51 and 60 and up to 90 percent of men over the age of 80.
The primary outcome measures of the Aptocine Phase 2 BPH trial are safety, according to number and severity of adverse events, and preliminary effectiveness, according to evaluation using the International Prostate Symptom Score (IPSS) and Bother Score (BS). Complete information on study protocol, investigators, and sites is available at ClinicalTrials.gov with the identifier: NCT00918034 (http://clinicaltrials.gov/ct2/show/NCT00918034).
About Aptocine
Aptocine is a water-soluble drug targeted inside a tumor or other tissue by a small, single-use, disposable drug activator included with the drug. The drug activator contains a tiny array of LEDs that emits red light at a discrete frequency and intensity, for a fixed time period, to activate Aptocine and create a "treatment region" around the LED array. Constant illumination with the LEDs' low-intensity light can activate each molecule of Aptocine many times, resulting in a continuous supply of singlet oxygen molecules that can kill target tissues with minimal side effects through vascular closure and apoptosis. The Aptocine drug activator used in BPH is a linear LED array inside a standard catheter, providing a simple, easy-to-administer outpatient treatment. Administering physicians insert the catheter with LED array into the urethra, inject Aptocine intravenously, and then energize the drug activator. Aptocine advantages over existing therapies for BPH may include minimal side effects, safety, and repeatability.
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