PLEASANTON, CA--(MARKET WIRE)--Oct 16, 2006 -- Lipid Sciences, Inc. (NASDAQ:LIPD) announced that a paper entitled "Delipidation of a Hepadnavirus: Viral Inactivation and Vaccine Development" by B.E. Cham*, K. Vickery et.al., appearing in the Journal of Virological Methods 137 (2006) 160-163, outlined a novel approach to the development of a vaccine against viral infection utilizing the process of viral delipidation. In this study, delipidated Hepatitis B virus was successfully used to vaccinate and protect young ducklings against a lethal challenge. The duck/duck hepatitis B model was chosen to demonstrate this principle because it has been used as a surrogate for Hepatitis B. The second aim of the study was to determine whether removing lipids from the envelope of DHBV (Duck Hepatitis B Virus) would preserve the viral proteins in their antigenic form -- which was successfully demonstrated. The results of this study support the premise that delipidation of lipid-enveloped viruses with specific organic solvent combinations has potential as a basis for the development of vaccines with a wide range of human and animal health animal applications.
Since the Viral Immunotherapy process makes the viral proteins more visible to the body's host-defense and antigen-presenting systems, Viral Immunotherapy may provide a basis for treating patients infected by lipid-enveloped viruses, including Hepatitis B and C, SARS, West Nile virus, influenza and others.
Various delipidated viruses have been shown in animal studies to provide cellular and/or antibody responses and even protection upon viral exposure. Viral Immunotherapy process has been shown to successfully delipidate the HIV particle and has the potential to be a therapeutic treatment for this disease. In vitro studies, including evaluation of viral particle morphology by electron microscopy, analysis of viral protein recovery and evaluation of post-delipidation viral infectivity, have been conducted at Johns Hopkins University. Studies in a mouse model at Emory University have been conducted to demonstrate both safety and immunogenicity.
During the year ended December 31, 2005, Lipid completed an exploratory investigation of the therapeutic effect of delipidated autologous virus in chronically SIV-infected non-human primates. The results of this study, conducted at the Yerkes National Primate Research Center at Emory University, demonstrated that the administration of autologous SIV viral antigen delipidated by Lipid delipidation process to chronically infected SIV-infected rhesus macaques led to an enhanced presentation of viral proteins by the animals' immune system, which was coincident with an improvement in the general indicators of overall health in these study animals. Statistical significance was reached both in the long-term survival of these animals compared to a retrospective, SIV-infected, non-immunized control group (p=0.0067), as well as a viral load reduction of approximately 90% (p=0.04), which was achieved for the nine months' duration of the study follow up period. With the successful completion of these studies, at December 31, 2005, the Company initiated a much larger, controlled non-human primate study to demonstrate both survival and viral load reduction in a statistically significant group of SIV-infected non-human primates. Lipid anticipates this study will last approximately 18 months. The study is designed to generate safety data and to demonstrate the efficacy of the proposed therapeutic treatment. gl