RVX-208 Exploratory Study Illustrates Early Potential for Alzheimer's Disease
First in class drug illustrates early signal of transport of key amyloid marker from brain TSX Exchange Symbol: RVX
CALGARY, November 10, 2008 /PRNewswire-FirstCall/ - Resverlogix Corp. ("Resverlogix") announced today that treatment with its lead drug RVX-208, a first in class ApoA-I/Prebeta-HDL elevating drug, in a post-hoc analysis from the Phase 1a clinical trial found that treatment with RVX-208 resulted in a positive trend on an important marker of cognitive function and Alzheimer's disease, Amyloid-beta40 is an important constituent of amyloid plaques in the brains of Alzheimer's patients. The analysis of the plasma markers for Alzheimer's disease was performed by Dr. D. Larry Sparks, Senior Scientist and Head of the Roberts Laboratory for Neurodegenerative Disease Research at Sun Health Research Institute in Sun City, Arizona.
The Phase 1a trial, a double-blind, dose-escalation, placebo-controlled trial enrolled 24 subjects in three separate dosing cohorts for a period of one week: 6 received placebo, and 6 received 2mg/kg per day, 6 received 3mg/kg per day and 6 received 8 mg/kg per day of RVX-208. Plasma levels of A-beta (A-beta40) were measured on day 1 and 7. A 12-14 percent increase in plasma A-beta40 levels was observed at the highest dose of RVX-208 after 7 days of dosing. Based on the study hypothesis these results trended towards significance versus placebo, even with the minimal number of study subjects.
Emerging evidence from large epidemiology studies such as the Harvard Women's Study, the Honolulu-Asia Aging Study and the Whitehall II study continue to build support for the relationship between poor HDL and ApoA-I levels and decreased cognitive function and Alzheimer's disease. Dr. Sparks's investigation of elective statin use and fractionated cholesterol levels in the ADAPT cohort has identified a significant relationship between elevated HDL levels and better performance on the Mini Mental State Examination (MMSE), and a significant inverse relationship between increased total and LDL cholesterol and learning and memory. Elevated cholesterol levels are thought to increase the production and accumulation of the putative AD neurotoxin, amyloid-beta (A-beta). The A-beta peptide is produced by aberrant cleavage of a larger precursor protein resulting in two lengths, either 42 or 40 amino acids long.
"Stemming from RVX-208's effects on ApoA-I, Prebeta-HDL production and the facilitation of reverse cholesterol transport, we hypothesized that RVX-208 might increase circulating A-beta40 levels through its effects on functional HDL, which can act as a sponge to draw A-beta40 from the brain to the circulation, for enhanced clearance from the body," stated Dr. Sparks. "Although it was a pilot study, with minimal subjects, we were pleased to find a positive signal and look forward to performing further research on RVX-208 in this critical area of unmet medical need," Dr. Sparks added.
"We are pleased and cautious about these early results," stated Kenneth Lebioda, Senior Vice President of Business and Corporate Development of Resverlogix. "This data provides important evidence solidifying our strategy to continue research efforts in this important disease area. We have always maintained a strategic life cycle management strategy that ensures the pursuit of important research in areas of critical unmet need. Our progress in Alzheimer's disease research illustrates our commitment to build a broad portfolio of opportunities in areas of unmet need for our lead drug and our NexVas(TM) platform technology. We look forward to continue our research collaboration with Dr. Sparks in this important medical area."
RVX-208, a first in class novel small molecule therapeutic that facilitates endogenous Apolipoprotein A-I (ApoA-I) production, is positioned to be one of the most promising emerging drugs in the treatment of atherosclerosis and vascular disorders such as Alzheimer's disease, vascular dementia, stroke, and Peripheral Artery Disease (PAD). ApoA-I, the critical cardioprotective protein of high-density lipoprotein (HDL) represent the bodies natural defense system against atherosclerosis by mediating reverse cholesterol transport (RCT), the transport of peripheral cholesterol including that of the vessel wall to the liver for processing. To the Company's knowledge RVX-208 is the only novel small molecule that is specifically designed to increase ApoA-I production and thereby raise Prebeta-HDL levels thus enhancing HDL functionality to augment reverse cholesterol transport (RCT) from vascular beds.
About Alzheimer's Disease
Every 71 seconds, someone in America develops Alzheimer's disease (AD) and it is estimated that by mid-century, someone will develop Alzheimer's every 33 seconds. Neurodegenerative diseases such as Alzheimer's are one of the most debilitating in the developed world with an estimated prevalence in the United States which is expected to grow to 15 million people by 2050. In a report commissioned by the Alzheimer's Association, caregiver costs in the United States are estimated at US$36.5 billion which includes loss of productivity, absenteeism and worker replacement. The indirect costs of AD would also be greatly reduced; it is estimated that one-half to two-thirds of the cost of AD care stems from unpaid caregivers (often family members), who spend 16-35 hours per week looking after a person with AD. These figures underscore the importance of developing new therapies to aide in the socioeconomic burden of AD.
About Sun Health Research Institute
For 21 years, Sun Health Research Institute, part of nonprofit Banner Health, has been a leader nationally and internationally in the effort to find answers to disorders of aging including Alzheimer's disease, Parkinson's disease, arthritis and prostate cancer. The institute, together with its Arizona Alzheimer's Consortium partners, has been designated by the National Institutes of Health as one of just 31 Alzheimer's disease Centers in the nation.
About Resverlogix Corp.
Resverlogix Corp. is a leading biotechnology company engaged in the development of novel therapies for important global medical markets with significant unmet needs. The NexVas(TM) PR program is the Company's primary focus which is to develop novel small molecules that enhance ApoA-I. These vital therapies address the grievous burden of atherosclerosis and other important diseases such as acute coronary syndrome, diabetes, Alzheimer's disease, Peripheral Artery Disease and other vascular disorders. The Company's secondary focus is TGF-Beta Shield(TM), a program that aims to address burgeoning grievous diseases, such as cancer and fibrosis. Resverlogix Corp. trades on the Toronto Stock Exchange . For further information please visit www.resverlogix.com.
This news release may contain certain forward-looking statements that reflect the current views and/or expectations of Resverlogix Corp. with respect to its performance, business and future events. Such statements are subject to a number of risks, uncertainties and assumptions. Actual results and events may vary significantly. The TSX Exchange does not accept responsibility for the adequacy or accuracy of this news release.
CONTACT: Theresa Kennedy, VP, Corporate Communications, Resverlogix Corp.,Phone: (604) 538-7072, Fax: (403) 256-8495, Email: ;Sarah Zapotichny, Manager, Investor Relations, Resverlogix Corp., Phone:(403) 254-9252, Fax: (403) 256-8495, Email: Theresa@resverlogix.com Sarah@resverlogix.com
Ticker Symbol: (Toronto:RVX)
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Posted: November 2008