FDA Approves Energex Systems' Pilot Study of Experimental Non-Pharmicalogical Treatment for Hepatitis C

Business Wire, June 14, 2004

Business Editors/Health/Medical Writers

BIOWIRE2K

EMERSON, N.J.--(BUSINESS WIRE)--June 14, 2004

Energex Systems, Inc. announced today that it has been granted conditional approval from the Federal Food and Drug Administration (FDA) to utilize its experimental, Hemo-Modulator technology in a clinical trial of patients suffering from Hepatitis C (HCV). The initial trial of 10 subjects, that have failed all other conventional therapies, will be conducted at Eisenhower Medical Center in Rancho Mirage, CA.

Hepatitis C is a viral infection of the liver and a major cause of acute hepatitis and chronic liver disease, including cirrhosis and liver cancer, and is now recognized as the leading cause of liver transplantation in the United States. HCV is spread primarily by direct contact with human blood. The World Health Organization estimates that about 170 million people are infected with HCV, about 3% of the world's population. Approximately 5 million Americans are infected with HCV, and there are 8,000-10,000 such deaths each year in the United States.

There is no vaccine against HCV and no completely effective treatment. Antiviral drugs such as Interferon (Hoffmann-La Roche, Schering-Plough, Intermune) taken alone or in combination with Ribavirin, (ICN Pharmaceuticals) can be used for the treatment of persons with HCV, but the cost of treatment is very high with numerous side effects. When combined, it is estimated that these drugs are effective in 30% to 50% of patients.

The experimental treatment involves exposing a very small amount of an infected subjects blood (3-4%) to a very precise amount of ultra-violet light in the C band (UVC), for a very precise amount of time, explained Thomas Petrie, the developer of the technology and Director of Engineering at Energex Systems. "During treatment, a percentage of any pathogen in the blood that is exposed to the UVC energy is inactivated. After exposure, the blood carrying the inactive pathogen is returned to the patient through the same portal it was drawn from. The result, we believe, is a stimulation of the immune system. If we can safely inactivate a virus and return it to the patient it came from, the theory of a vaccine suggests that this therapy should be effective in managing these deadly diseases", said Petrie. "We didn't develop UVC nor were we the first to theorize that it destroys viruses. What we did, we believe, was develop a process to safely expose infected blood to UVC and proved a common theory that it destroys pathogens", said Petrie. The process takes 20-30 minutes.

"We are obviously very pleased with the FDA's decision to grant us approval to begin this very important clinical trial, and equally excited about the potential that the technology has to manage this hard-to-treat disease, to reduce the cost of care, and to provide a better quality of life for the millions that suffer from it", said Thomas J. Fagan, President of the company. "We are committed to expending whatever resources are necessary to see that this technology continues through the research and approval processes, and that it is accepted by the medical community as the treatment of choice for this potentially life threatening disease". "This clinical trial will be the first step in doing that", said Mr. Fagan.

Energex Systems is dedicated to developing medical technologies and therapies with an emphasis on the treatment of conditions unmet by present day therapies and reducing the cost of care.