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, which inhibit the secretion of gastric acid and reduce the acidity of the stomach. Patients that took PPI regularly during the trial showed an increased CRD5 efficacy with a mean HDL increase from baseline of 16% at 1 gram (n=4) and 14% at 3 grams (n=3).
"We are very encouraged by these results. We are seeing the best effect in patients that can most benefit from CRD5, at dose levels that are commercially viable," said Bill Dickie, President and CEO of Liponex. "These results, particularly the impact of PPI on CRD5 efficacy, support our ongoing preclinical studies and guide our strategy to optimize the formulation and dosing regimen for CRD5 clinical development."
The company believes that it can resolve CRD5 pH sensitivity and boost the efficacy of CRD5 with well-established enteric coating strategies. Preclinical experimental work is underway to confirm this view and then an additional clinical trial will be undertaken with results expected in the first quarter of 2008. The company has filed a novel formulation patent application to cover these initial findings and to further protect its competitive position.
About Liponex Liponex is a biopharmaceutical company specializing in developing products related to High Density Lipoprotein (HDL), often called "good cholesterol." Its drug candidates relate to the various roles of HDL as a transport vehicle, including removing excess cholesterol from the body, delivering molecules to cells and removing unwanted materials from the body. Liponex is listed on the TSX under the ticker "LPX". For more information on Liponex, visit www.liponex.ca.
Certain of the statements contained in this press release contain forward-looking statements which involve known and unknown risks, uncertainties and other important factors which may cause the actual results, performance or achievements of the Company, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements of "belief" with respect to reformulation, the undertaking of an additional clinical trial for CRD5 as well as CRD5's efficacy in raising HDL levels, are based primarily upon results derived to date from the Company's pre-clinical research and development and its results from completed Phase I and Phase I/II clinical trials. While the Company believes that it has reasonable scientific basis upon which to make such statements, it is not possible to predict whether a new therapeutic agent will be prove to be safe and/or effective in humans. The Company cannot guarantee that it actually will achieve the plans, intentions or expectations. and undue reliance should not be placed on those forward-looking statements. The Company does not expect to update forward-looking statements continually as conditions change. Investors are referred to the full discussion of risk factors associated with the Company's business contained in the Company's periodic regulatory filings, which can be found in the SEDAR database at www.sedar.com.
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