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Light Sciences Oncology Initiates Phase III Trial of Its Light Infusion Therapy (Litx(TM)) in Patients With Metastatic Colorectal Cancer

Posted on: Tuesday, 17 July 2007, 09:03 CDT

Light Sciences Oncology, Inc. (LSO) today announced the treatment of the first patient in its Phase III trial of Litx for colorectal cancer metastatic to the liver (MCRC). The pivotal Phase III trial is the final trial required before Litx can be submitted to the U.S. Food and Drug Administration (FDA) for marketing approval. Initiation of the study follows an agreement reached in January 2007 with the FDA on a Special Protocol Assessment (SPA).

In a two-arm controlled randomized study expected to involve approximately 450 colorectal cancer patients with liver metastases, the trial is designed to demonstrate the superiority of Litx treatment in combination with standard chemotherapy compared with standard chemotherapy alone. Treatment efficacy will be measured with progression-free survival (PFS), as well as overall survival. LSO has arranged with Ergomed Research Ltd., a clinical development company based in Frankfurt, Germany, and its U.K. subsidiary Ergomed Clinical Research Ltd., to assist with conduct of the Litx MCRC Phase III trials in Europe, Eastern Europe, and the United States.

"With the treatment of our first patient in the Phase III trial in MCRC, we have reached another important milestone in our development of Litx," said Llew Keltner, M.D., Ph.D., President and CEO of Light Sciences Oncology. "Together with our current Phase III study in hepatoma and Phase II study in glioma, the MCRC trial shows our determination to provide safer and more effective treatment to cancer patients."

Despite decades of research targeting solid tumors, those cancers continue to confound the best efforts at treatment. The worldwide incidence of colorectal cancer is approximately one million cases per year. The National Cancer Institute reports that approximately 50% of patients diagnosed with colorectal cancer will suffer from advanced disease that has metastasized to other parts of the body, most commonly to the liver. Only about one in 10 MCRC patients survive beyond five years.

Litx uses light-emitting diodes (LEDs) to activate LS11 (talaporfin sodium). An activated LS11 molecule results in the production of singlet oxygen which can kill target tissues with minimal side effects through vascular closure and apoptosis, or "programmed cell death." Constant illumination can activate each molecule of LS11 many times, resulting in a continuous supply of singlet oxygen molecules. The palm-sized, single-use, disposable Litx device contains a tiny array of LEDs at the end of a very narrow (1.2 mm wide) flexible catheter-like conductor. Administering physicians insert the LED array into a tumor using a biopsy-like procedure requiring only a local anesthetic followed by intravenous injection of LS11. Emitting red light at a discrete frequency, intensity, and time period, the device activates LS11 in a predictable "kill zone" around the LED array. Unlike laser-based light-activated therapies, Litx does not require expensive equipment.

Litx may avoid the serious toxicities associated with traditional treatments. It attacks tumors from the inside-out, rather than outside-in, the method used in many standard treatments. Litx kills all tumor cells in the kill zone, rather than only the minority of cells undergoing rapid division. The Litx treatment may also close tumor blood supply vessels, starving remaining cancer cells of oxygen and nutrients. The use of multiple light sources and multiple treatments is feasible and can be tailored based on the size, shape, and location of the target tumors.

ABOUT LIGHT SCIENCES ONCOLOGY

Light Sciences Oncology, Inc. (LSO) is developing Light Infusion Therapy (Litx™) to provide safer and more effective treatment to cancer patients. In addition to the Phase III trials in hepatocellular carcinoma and colorectal cancer metastatic to the liver, the Company is conducting a Phase II clinical trial of Litx in glioma. In December 2006, LSO purchased the assets of its former parent company Light Sciences Corporation (LSC), securing all Litx intellectual property and widening its scope of potential therapeutic applications to include benign neoplasms such as benign prostatic hyperplasia (BPH) and uterine fibroids, as well as vascular disease, dermatology, and all other applications of the versatile Litx platform. The Company has positioned itself for growth with a strong portfolio of intellectual property, innovative applications in development, and an exceptionally talented team.

Light Infusion Therapy™ and Litx™ are trademarks of Light Sciences Oncology, Inc.

Source: Business Wire

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