Lipid Sciences' selective delipidation process demonstrates enhanced ability in removing cholesterol from cells

Nov 8 2004

Lipid Sciences announced today that researchers have successfully used the Company's proprietary "selective delipidation" process to create a modified form of HDL ("good cholesterol") that is known to be more effective in reverse cholesterol transport, the body's natural process for removing lipids from arterial plaque.

The results of the proof of concept study were presented yesterday by Frank M. Sacks, M.D., Professor of Cardiovascular Disease, Harvard School of Public Health, and a member of Lipid Sciences' Scientific Advisory Board, at a Scientific Session of the annual meeting of the American Heart Association in New Orleans, Louisiana.

In the selective delipidation process, researchers demonstrated the ability of Lipid Sciences' device and LSI-S955 selective delipidation agent to remove lipids from the naturally-occurring HDL found in human plasma. The process successfully transformed the more common alpha HDL into a form known as pre-beta HDL that is significantly more effective in helping the body collect and remove cholesterol found in arterial plaque that is associated with atherosclerosis.

Dr. Sacks noted, "The key finding in this study is that we can now enhance the patient's own plasma by creating a high concentration of the pre-beta form of HDL that is known to be most effective in helping to reverse the build-up of arterial plaque. This finding could have a profound impact on the success of Lipid Sciences' HDL Therapy in treating atherosclerosis in the years ahead."

Using Lipid Sciences' proprietary selective delipidation process, researchers were able, for the first time ever, to remove lipids from only the targeted HDL without significantly affecting or altering LDL or any other plasma lipoproteins. Historically, other methods used to remove lipids from plasma also removed lipids from both HDL and LDL as well as other plasma lipoproteins.

"One of the great challenges in this research was the need to remove lipids from HDL without significantly altering the other important lipoproteins found in human plasma. With this new and novel process we can now target the specific lipids necessary to transform alpha HDL into pre-beta HDL with no significant impact on other lipoproteins' composition or metabolism," Dr. Sacks added.

HDL Therapy involves treating a patient's plasma with Lipid Sciences' proprietary selective delipidation process. The delipidated HDL particles created have been shown to be approximately 20 times more effective in cholesterol efflux, the process where cholesterol is removed from cells. Delipidated plasma administered into mice, pigs, and monkeys has shown no adverse biochemical or physiological side effects.

Dr. S. Lewis Meyer, President and CEO of Lipid Sciences, Inc., said, "The results of this breakthrough science are very encouraging and confirm that we can use our proprietary selective delipidation system to create a highly- concentrated population of pre-beta HDL particles that have been shown to be more effective in cholesterol efflux. We are working aggressively to continue and expand the scope of both our research and system development. We anticipate holding a pre-Investigational Device Exemption (IDE) meeting with the United States Food and Drug Administration (FDA) around the end of this year. We then plan to file an IDE with the FDA in mid-2005 and initiate the process of a human trial around the fourth quarter of 2005."

In September 2004 Lipid Sciences announced the initiation of a non-human primate study that is being conducted at the Wake Forest University Baptist Medical Center under the direction of Dr. Lawrence L. Rudel. This pre-clinical animal study is designed to demonstrate the safety and efficacy of the Company's HDL Therapy process in a relevant human-like model. The successful conclusion of this innovative study will provide a potentially new therapeutic approach in the treatment of cardiovascular diseases, such as heart attacks and strokes, in the high-risk patient.

The study subjects are African green monkeys that are a widely-accepted model for human atherosclerosis. These study subjects are surveyed with intravascular ultrasound (IVUS) to determine the presence and composition of arterial plaque. The endpoint of this study will be the measurement of arterial plaque regression as determined by comparing plaque volume by IVUS at the beginning and at the end of the treatment cycle. Analysis of this data will occur under the direction of Dr. Steven E. Nissen at the Cleveland Clinic Foundation.