OTTAWA, Oct. 19 /PRNewswire/ -- Liponex Inc., a biopharmaceutical company specializing in the development of charge regulating drugs (CRD), today announced that it has been granted a U.S. patent allowance for its first product, CRD5, a novel drug in development for the treatment of cholesterol and atherosclerosis. The company also announced the results of Phase I human trials of CRD5.
The Phase I trials, conducted at the University of Ottawa Heart Institute on 56 volunteers over a two-week dosing period, were designed to test the safety of CRD5. No negative health effects were observed and the trial results confirmed that the drug is safe and well-tolerated.
The trials also showed significant preliminary efficacy results, indicating that CRD5 increased levels of HDL, or good, cholesterol by an average of 18% in the high dose group over the same two-week period. In addition, levels of LDL, or bad, cholesterol and triglyceride were seen to decline by as much as 15% and 60% respectively. Liponex will present the full results of the trials at the Canadian Lipoprotein Conference in Banff, Alberta on October 23, 2004.
“Even though these are very early stage trials, performed on a relatively small number of subjects, the data that we have collected is compelling,” said Dr. Daniel Sparks, founder and Chief Scientist, Liponex. “The trials confirm our laboratory studies showing that CRD5 has great potential for the treatment of heart disease, which, year after year, remains the number one cause of mortality in the developed world.”
When too much LDL cholesterol circulates in the blood, it can slowly build up in the inner walls of the arteries that feed the heart and brain and form a hard deposit that can clog those arteries. High triglyceride is an independent risk factor that also contributes to heart disease. HDL is considered good cholesterol by experts, as high levels of it appear to protect against heart disease. HDL is known to play a role in removing both LDL cholesterol and triglycerides from the bloodstream.
Studies have suggested that higher HDL levels reduce the occurrence of heart disease, with each 1% increase in HDL cholesterol correlating to a reduction of 3% in the incidence of heart disease.
“The treatment of high cholesterol by increasing HDL levels is a very promising area of development in today’s drug market,” said Dr John Kastelein, Chairman, Department of Vascular Medicine at the Academic Medical Center, Amsterdam. “The early results that Liponex has observed in the trials of CRD5 are extremely exciting and give added hope to the battle against heart disease.”
The technology behind CRD5 was initially discovered through research at the University of Ottawa Heart Institute (UOHI). In order to further develop and market the drug, the Heart Institute exclusively licensed the technology to Liponex Inc. and continues to support the company with its ongoing research in the field.
Phase II trials of CRD5, designed to show efficacy in patients with abnormal cholesterol levels, are planned for 2005.
About Liponex
Liponex Inc. is a biopharmaceutical company specializing in the development of charge regulating drugs (CRD), which are special charged therapeutic drugs for the natural elimination of harmful compounds. Liponex’s first product, CRD5, is designed to increase good cholesterol (HDL) levels. Other CRD products are being developed that promote viral clearance and the elimination of bacterial toxins. The company is also developing an HDL drug carrier technology that will enable a drug payload to be carried to specific target areas in the body, such as cancerous tissue. For more information, visit: http://www.liponex.ca/ .
Liponex inc.
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