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Light Sciences Oncology Announces Progress in Liver Cancer Trials

Posted on: Friday, 13 May 2005, 15:00 CDT

SEATTLE, May 13 /PRNewswire/ -- Light Sciences Oncology announced today that preliminary Phase 2 clinical study results using the Light Infusion Technology(TM) (Litx(TM)) treatment with the drug LS11 are to be published in the 2005 American Society of Clinical Oncology (ASCO) Annual Meeting Proceedings. Litx is the combination of a proprietary photoreactive agent (LS11) activated by a proprietary non-coherent light infusion device which is placed through the skin directly into the center of the tumor in an outpatient setting.

The objectives of the study were to determine the efficacy of Litx in terms of time to progression and tumor response over a 60 day evaluation period, as well as to verify the safety of the regimen in the liver, as has been reported previously with Litx in tumors in other locations throughout the body. In addition, the study was designed to determine whether concurrent chemotherapy presented any cumulative safety issues. A total of 27 patients with colorectal cancer metastatic to the liver were treated with Litx at 4 centers in the United States and 5 Centers in Europe. In 8 patients Litx was combined with the "gold standard" chemotherapy regimen in place at the institution where these patients were treated.

Phase 2 Trial Results

The observed occurrences of Litx treatment-related adverse events were minimal and no cutaneous phototoxicity was observed. The combination of Litx plus chemotherapy was found to be safe.

Overall tumor response rate, corroborated by independent radiologist reviews, was 24% in Litx treated tumors vs. 10% in untreated tumors utilizing standard RECIST tumor response criteria. The disease control rate, which includes tumors, which do not continue to grow, was 83% in Litx treated tumors.

Time to progression in tumors treated with Litx was 61 days -- the length of the study -- compared to 33 days for untreated lesions.

"We are hopeful that this work and the further development of Litx may one day allow solid tumor cancers to be treated as a chronic disease rather than an acute, life-threatening condition," said Llew Keltner, M.D., Ph.D. President and CEO of Light Sciences Oncology. "We are pleased that the safety data have been so uniformly positive and also with the initial indications of efficacy evident in the study results. We are encouraged that such favorable results may carry through to our future Phase 3 trials in primary hepatocellular carcinoma (hepatoma), metastatic colorectal cancer and other solid tumors."

The final report for this Phase 2 study was submitted to FDA in April 2005. The protocol for a US/European Phase 3 study in metastatic colorectal cancer will be submitted to FDA for final review in June 2005.

Additional and Upcoming Trials

Based on the results of the Phase 2 study of Litx in colorectal liver metastases, Light Sciences Oncology has initiated a short Phase 2 trial in hepatoma leading to a major Phase 3 pivotal trial later this year designed to provide data to support applications for regulatory approval. The Phase 3 trial, which will be conducted in Asia for approval for sale in the US, Taiwan, Singapore, and Hong Kong, is the subject of a Special Protocol Assessment submitted to the FDA in April 2005. Hepatoma is the deadliest cancer in the world; although the majority of cases are now in Asia, the rate of disease incidence in the US is rising at a dramatic rate. If successful, the Litx study will be the first demonstration in a controlled registration trial of increased survival for hepatoma patients as a result of any therapy other than surgery, which is only an option in a small minority of hepatoma patients. The Phase 2 Litx study is now open at 7 trial centers in Taiwan, Singapore and Hong Kong and first patients in the trial will be treated within a few weeks.

Light Sciences licensed LS11 from the Japanese company Meiji Seika Kaisha in early 2000. Meiji Seika received marketing approval from Japanese authorities in 2003 for the use of Laserphyrin (Meiji Seika's version of LS11) to cure early stage endobronchial lung cancer.

About Light Sciences Oncology

Light Sciences Oncology is a privately owned company formed in 2005 to develop and commercialize the Oncology assets of Light Sciences Corporation. Light Sciences Corporation was founded in 1995, and is also a privately financed company which developed Light Infusion Technology(TM) (Litx(TM)), a proprietary combination product containing a photoreactive agent (LS11) activated by non-coherent light infusion devices. In 2005, Light Sciences Corporation created three unique, subsidiary companies developing Litx(TM) for eye disease, cancer and cardiovascular disease respectively:

-- Visient Therapeutics, Inc.: Targeting age-related macular degeneration (AMD) and other eye diseases, Visient Therapeutics is recruiting patients for a Phase 1/2 clinical trial in patients with the wet form of AMD. Age-related macular degeneration is the leading cause of blindness in the population aged more than 50 years.

-- Light Sciences Oncology, Inc.: Targeting primary liver cancer, colorectal liver metastases and other solid tumors, Light Sciences Oncology has finished a global multi-center Phase 2 clinical trial treating patients with liver metastases due to colorectal cancer. Metastatic colorectal cancer is a leading cause of cancer death in the western world, with nearly 60,000 fatalities annually in the U.S. alone. The company plans to begin a Phase 2 trial of Litx in May 2005 in patients with hepatocellular carcinoma, which is among the most malignant of cancers and afflicts more than 1,000,000 people per year worldwide.

-- Vascular Reconditioning, Inc.: Targeting atherosclerosis, Vascular Reconditioning is developing a new treatment for interventional cardiologists to use against vulnerable plaque, the underlying disease trigger in over one million coronary attacks in Americans each year, from which around 40% will die.

NOTE: Light Sciences(R), Litx(TM) and Light Infusion Technology(TM) are registered or proprietary marks of Light Sciences Corporation.

CONTACT: Llew Keltner, M.D., Ph.D., President and CEO Light Sciences Oncology, 425-369-2800, or dr_llew@epistat.com.

Light Sciences Oncology

CONTACT: Llew Keltner, M.D., Ph.D., President and CEO Light SciencesOncology, +1-425-369-2800, or dr_llew@epistat.com

Web site: http://www.lightsciences.com/

Source: PRNewswire

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