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Liponex Inc. Reports Further Analysis of CRD5 Phase I/II Clinical,Trial Data

OTTAWA, April 11 /CNW/ - Liponex Inc. (TSX:LPX), a biopharmaceutical company specializing in developing advanced products related to High Density Lipoprotein (HDL), often called "good cholesterol," today announced information from further analysis of the Phase I/II Clinical Trial of its lead product, CRD5. CRD5 is being developed for the treatment of dyslipidemia and heart disease.

A detailed review of patient information indicated that all blood chemistry and blood pressure measurements were within the normal or expected ranges. CRD5 was shown to be safe in dyslipidemic patients. In addition, the drug was well-tolerated in the patient group, with the exception of the reported GI adverse events that led to the cessation of the 5 gram dosing phase.

As previously reported, the overall mean HDL increase was 5% at both the 1g (n=50) and 3g (n=40) dosing levels but the patient to patient variation was high. While some patients had a negative response, over 20% of patients achieved more than a 10% rise in HDL at the lower dose levels.

The patient information was reviewed to determine if there were any patient characteristics that had an impact on the efficacy of CRD5. Some patients were taking other medications during the trial that may have had lipid altering effects and these subjects appeared to have reduced response to CRD5. Data from these subjects were removed and the trial results were reanalyzed. CRD5 appeared to be more effective in patients with baseline plasma HDL-cholesterol levels of less than 0.9 mM. This level of HDL is considered to be abnormal and is associated with elevated risk of developing heart disease. Those patients (n=17) with starting HDL levels below 0.9 mM averaged an 11% increase in HDL levels from baseline at the 3 gram CRD5 dosing level.

Of note, several patients were identified to have taken proton pump inhibitors (PPI), such as ranitidine and lansoprazole,
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