Resverlogix Initiates Phase 2 Clinical Trial of RVX-208 in Patients with Pre-Diabetes Mellitus
TSX Exchange Symbol: RVX
CALGARY, Oct. 16, 2012 /PRNewswire/ - Resverlogix Corp. (TSX:RVX) today announced that it has initiated an exploratory Phase 2 clinical trial in patients with pre-diabetes mellitus to examine the effects of RVX-208 and ApoA-I production on glucose metabolism. The trial is conducted in collaboration with Baker IDI Heart & Diabetes Institute in Melbourne, Australia, and it will examine insulin secretion, insulin sensitivity and other parameters of importance in individuals with pre-diabetes mellitus. Twenty patients will be enrolled in Australia, with data expected in the first half of 2014.
The foundation of this trial builds upon the actions of RVX-208 and the knowledge that this compound triggers a key epigenetic pathway resulting in enhanced ApoA-I protein production to raise the body's level of functional HDL particles. The effect of newly created ApoA-I/HDL may help to preserve pancreatic cells that make and secrete insulin. Increased abundance of insulin in subjects with pre-diabetes mellitus may prevent or substantially delay the progression towards diabetes mellitus. The estimated trial expense will be less than $1MM CDN with an approximate split in costs of 50/50 between Resverlogix and the Baker IDI Heart & Diabetes Institute.
"Diabetes mellitus is the most common endocrine disease in the world," said Dr. Norman Wong, Chief Scientific Officer, Resverlogix. "The prevalence of this disease is rising at epidemic rates. A primary defect in diabetes mellitus is that the patient's pancreas cannot provide enough insulin for the body, thus leading to increased blood glucose levels. Diabetes mellitus can lead to severe sequelae such as kidney disease, heart disease, disorders of the nerves and blindness. Altering the natural course of the disease could be of great benefit to patients.
"This planned exploratory trial is an important prerequisite to potentially expand the indications for RVX-208 to type 2 diabetes mellitus."
RVX-208 is a first-in-class, small molecule that inhibits BET bromodomains. It is currently in clinical study for the treatment of atherosclerosis. RVX-208 functions by removing atherosclerotic plaque via reverse cholesterol transport (RCT), the natural process through which atherosclerotic plaque is transported out of the arteries and removed from the body by the liver. RVX-208 increases production of ApoA-I, the key building block of functional high-density lipoprotein (HDL) particles and the type required for RCT. These newly produced functional HDL particles are flat and empty and can efficiently remove plaque and stabilize or reverse atherosclerotic disease. RVX-208 is currently being evaluated in phase 2b studies for its ability to reverse and/or stabilize atherosclerotic disease. The drug candidate also has the potential to treat other indications, including neurodegenerative disorders and diabetes mellitus.
Resverlogix Corp. (TSX: RVX) is a clinical stage cardiovascular company with an epigenetic platform technology that modulates protein production. Resverlogix is developing RVX-208, a first-in-class small molecule for the treatment of atherosclerosis. RVX-208 is the first BET bromodomain inhibitor in clinical trials. New compounds arising from Resverlogix's epigenetic drug discovery platform function by inhibiting BET bromodomains and have the potential to impact multiple diseases including autoimmune diseases, cancer, neurodegenerative diseases and diabetes mellitus. Resverlogix's common shares trade on the Toronto Stock Exchange (TSX: RVX). For further information please visit www.resverlogix.com.
This news release may contain certain forward-looking information as defined under applicable Canadian securities legislation, that are not based on historical fact, including without limitation statements containing the words "believes", "anticipates", "plans", "intends", "will", "should", "expects", "continue", "estimate", "forecasts" and other similar expressions. In particular, this news release includes forward looking information relating to research and development activities and the potential role of RVX-208 in the treatment of atherosclerosis. Our actual results, events or developments could be materially different from those expressed or implied by these forward-looking statements. We can give no assurance that any of the events or expectations will occur or be realized. By their nature, forward-looking statements are subject to numerous assumptions and risk factors including but not limited to those associated with the success of research and development programs, clinical trial programs including possible delays in patient recruitment, the regulatory approval process, competition, securing and maintaining corporate alliances, market acceptance of the Company's products, the availability of government and insurance reimbursements for the Company's products, the strength of intellectual property, financing capability, the potential dilutive effects of any financing, reliance on subcontractors and key personnel and additional assumptions and risk factors discussed in our Annual Information Form and most recent MD&A which are incorporated herein by reference and are available through SEDAR at www.sedar.com. The forward-looking statements contained in this news release are expressly qualified by this cautionary statement and are made as of the date hereof. The Company disclaims any intention and has no obligation or responsibility, except as required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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SOURCE Resverlogix Corp.