Litx™ Therapy

Development Pipeline

LSO is focusing on three cancers for the initial development of Litx™: Hepatoma, Metastatic Colorectal Cancer and Glioma.

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Current Clinical Trials

Phase III trials are underway in hepatocellular carcinoma and colorectal cancer metastatic to the liver.

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Litx uses light-emitting diodes (LEDs) to activate LS11 (talaporfin sodium), a light-activated, water-soluble drug. An LS11 molecule activated by the Litx system results in the production of singlet oxygen, which can kill target tissues with minimal side effects. Litx uses low-intensity light that causes vascular closure and apoptosis, or “programmed cell death.” Constant illumination with low-intensity light can activate each molecule of LS11 many times, resulting in a continuous supply of singlet oxygen molecules.

The Litx device contains a tiny array of LEDs at the end of a very narrow (only 1.2 mm wide) flexible coated micro-wire. Administering physicians insert the LED array into a tumor using a biopsy-like procedure, followed by intravenous injection of LS11. The device emits red light at a discrete frequency and intensity, for a fixed time period, to activate LS11 and create a “kill zone” around the LED array. Unlike radiation therapy, laser-based light-activated therapies, or thermal tissue destruction methods, Litx does not require expensive equipment.

There is no evidence that Litx causes the serious toxicities associated with traditional cancer treatments such as bone marrow suppression, immune system suppression, marked fatigue, mucositis, and hair loss.

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

Additionally, Litx may have a systemic effect on untreated tumors. In 2007, data from several published animal and human studies suggested that the production of large apoptotic masses in tumors using photodynamic therapy yields tumor-specific clones of CD8+ T-cells which infiltrate distant, untreated tumors and destroys them or reduces their size. LSO is currently sponsoring two animal studies to determine whether treating tumors with Litx produces a similar result.

LS11™

LS11™ (talaporfin sodium) is a pure, semi-synthetic compound developed in Japan by Meiji Seika and Eneos under the Laserphyrin® brand name. Laserphyrin® was approved for commercial use in Japan in October 2003 for the laser-activated treatment of early-stage bronchopulmonary lung cancer. LSO subsequently developed a proprietary synthetic method for the production of LS11, the drug component of Litx in which talaporfin sodium is the active ingredient. Preliminary clinical data shows, among other things, a lower risk of skin photosensitivity due to the shorter half-life and greater water solubility of LS11 compared to the light-activated drugs used in currently approved light-activated drug therapies.