
WINNIPEG, MANITOBA -- (Marketwire) -- 02/12/13 -- Miraculins Inc. (TSX VENTURE: MOM), a medical diagnostic company focused on acquiring, developing and commercializing diagnostic tests and risk assessment technologies for unmet clinical needs, announces today the start of a pilot study to measure skin cholesterol levels in patients beginning statin therapy. The pilot study, sponsored by Miraculins, is being conducted at the Winnipeg Clinic and will measure skin cholesterol levels using the second format of Miraculins' PreVu® Non-Invasive Skin Cholesterol Test technology - The PreVu Lab Processed (LP) Test. The study is designed to assess the degree of correlation between changes in skin cholesterol and serum cholesterol during statin treatment, and how statin treatment impacts skin cholesterol levels based on measurements taken at multiple time points over a six-month period.
Statins are a class of lipid lowering drugs that inhibit cholesterol biosynthesis in the liver. They have emerged as one of the best-selling medication classes and are the most widely prescribed lipid lowering medication in the world. In 2011, over 20 million Americans were taking some type of statin.
"This pilot study, in a small number of patients, is meant to establish a clearer signal for the behavior of skin cholesterol in response to therapy. Although a great deal of clinical evidence exists establishing the utility of measuring skin cholesterol as a risk factor for coronary artery disease, limited scientific data has been developed to understand the behavior of this novel biomarker over multiple time points, particularly in response to the administration of therapy such as statins," commented Dr. Michael J. Evelegh, Vice President, Product Development of Miraculins Inc. and co-author of numerous publications on skin cholesterol.
"Statins are one of the most frequently prescribed drugs and patients taking these medications must periodically provide blood samples for testing, which can be unpleasant and inconvenient. Additionally, statins are one of the most patient-neglected medications prescribed, with significant numbers of patients failing to maintain their medication regimens. Should skin cholesterol ultimately be shown to correlate with response to therapy, this non-invasive skin cholesterol test might prove in the future to be a more convenient drug therapy monitoring method," continued Dr. Evelegh.
"We are active in advancing our PreVu LP Test and supporting the scientific development and awareness of skin cholesterol as an emerging biomarker in the fight against coronary artery disease," said Christopher J. Moreau, President and CEO of Miraculins Inc. "This pilot study is consistent with our stated plans and goals for 2013, which include exploring additional test utilities. Based on a promising result the Company will be in a better position to consider alternatives for a larger study and for potential additional commercial opportunities that could result."
The PreVu LP Test, Miraculins' second testing format for skin cholesterol is being developed with Gamma-Dynacare Medical Laboratories, the Company's exclusive Canadian PreVu LP Testing partner. The PreVu LP Test non-invasively measures the amount of cholesterol that has been deposited in skin tissues by painlessly and rapidly collecting skin cells from the palm of the hand using a proprietary medical adhesive collection device, which is then sent to a central reference laboratory for processing and results reporting.
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Miraculins Initiates Pilot Study to Measure Skin Cholesterol Levels in Patients Beginning Statin Therapy
Feb 12 2013 12:00AM
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