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Resverlogix Corp T.RVX

Alternate Symbol(s):  RVXCF

Resverlogix Corp. is a Canada-based late-stage biotechnology company. The Company is engaged in epigenetics, with a focus on developing therapies for the benefit of patients with chronic diseases. Its epigenetic therapies are designed to regulate the expression of disease-causing genes. The Company's clinical program is focused on evaluating its lead candidate apabetalone (RVX-208) for the treatment of cardiovascular disease and associated comorbidities, and post-COVID-19 conditions. RVX-208 is a small molecule that is a selective bromodomain and extra-terminal (BET) inhibitor. BET bromodomain inhibition is an epigenetic mechanism that can regulate disease-causing genes. RVX-208 is a BET inhibitor selective for the second bromodomain (BD2) within the BET proteins. It partners with EVERSANA, to support the commercialization of RVX-208 for cardiovascular disease, post-COVID-19 conditions, and pulmonary arterial hypertension in Canada and the United States.


TSX:RVX - Post by User

Bullboard Posts
Post by funfinderon Jun 13, 2011 1:30pm
483 Views
Post# 18707945

News

News

Resverlogix Launches Phase IIb ASSURE Trial for RVX-208 Cholesterol Transport Drug, Safety Data Completed and Filed

Resverlogix Launches Phase IIb ASSURE Trial for RVX-208 Cholesterol Transport Drug, Safety Data Completed and Filed
TSX Exchange Symbol: RVX

CALGARY,June 13, 2011 /CNW/ - Resverlogix Corp. ("Resverlogix" or the"Company") (TSX:RVX) announced today that the Company has completed itschronic repeated-dose toxicology studies on its lead compound, RVX-208,indicated for the reduction and prevention of atherosclerosis. Thesechronic toxicology studies support the initiation of its longerduration, Phase IIb, clinical trial ASSURE. As a first-in-classcompound, RVX-208 underwent six and twelve month testing in rodents andnon-rodents, respectively, and the analysis, results and reporting ofthese studies to the appropriate regulatory authorities, have beencompleted.

With the safety studies complete, RVX-208 can nowadvance into trials of more than three months duration. The Phase IIbASSURE trial, in which Intra Vascular Ultra Sound (IVUS) technology willbe used to determine coronary arterial plaque regression, will have atreatment duration of six months. The IVUS measurement will be used asthe trial's primary endpoint.

Results from the recently completedASSERT trial strongly demonstrate that RVX-208 is efficacious inelevating new production of ApoA-1, the key protein in 'goodcholesterol', HDL cholesterol and HDL Alpha1 sub particles. None ofthese reverse cholesterol transport biomarkers appear to have reachedtheir plateaus at the completion of that 12 week trial. As a result,Resverlogix was required by the FDA rules to complete the safety studiesin order to progress to a six month human clinical study.

Resverlogixhas identified more than 60 clinical sites in eight countries that willparticipate in the ASSURE trial study. The Cleveland Clinic will serveas the trial co-manager and coordinate all data management and readoutsof the primary endpoint. Countries with secured trial sites are locatedin both Europe and South America. With the completion of these chronicrepeated-dose toxicology studies, Resverlogix has commenced the requirednational approval filings. Upon completion of regulatory filings ineach specific country, Resverlogix will then commence enrollment anddosing procedures.

"We are pleased to have completed and filedthe data associated with the repeated-dose toxicology studies and thatthe trial is progressing according to timelines that we had previouslydiscussed," said Donald J. McCaffrey, Resverlogix President and ChiefExecutive Officer.

The ASSURE trial is a placebo-controlled,double-blind intervention trial designed by Resverlogix in conjunctionwith the Cleveland Clinic and the Clinical Steering Committee,consisting of Drs. Steve Nissen, John Kastelein, Christie Ballantyne,Phil Barter, and principal investigator Dr. Stephen Nicholls. The trialpatient population will be selected from patients referred for coronaryangiography who meet selected angiographic criteria. Approximately 310patients will participate, of which 77 will receive placebo and 233 willreceive RVX-208 treatment. Clinical trial information will be postedon www.Clinicaltrials.gov prior to first dosing.

WebcastAnnouncement: In additional news Resverlogix Corp. will host a liveAnalyst teleconference and webcast on Tuesday, June 21st at 11:00amMountain time. The purpose of the teleconference is to provide a marketupdate from management regarding clinical trial developments. Thedial-in numbers for this event will be 1-800-319-4610 and international1-604-638-5340. A link for this webcast will be posted onto the homepageof Resverlogix' website and can be accessed from the following address
https://services.choruscall.com/links/resverlogix110613.html .

The webcast will be available on the Resverlogix website for a period of 45 days after the event.

About RVX-208

RVX-208,a novel small molecule therapeutic that facilitates endogenous ApoA-1production, is positioned to be one of the most promising emerging drugsin the treatment of atherosclerosis. To the Company's knowledge RVX-208is the only novel small molecule that is specifically designed toincrease ApoA-I production and thereby raise HDL levels thus enhancingHDL functionality to augment reverse cholesterol transport (RCT). RCT isa pathway by which accumulated cholesterol is transported from thearterial wall to the liver for excretion, thus reducing or preventingatherosclerosis.

About Resverlogix Corp.
Resverlogix Corp. is aleading biotechnology company engaged in the development of noveltherapies for important global medical markets with significant unmetmedical needs. The NexVas™ PR program is the Company's primary focuswhich is to develop novel small molecules that enhance ApoA-1production. These vital therapies are focused to address the burden ofatherosclerosis and other important diseases such as Acute CoronarySyndrome, Diabetes, Alzheimer's disease, Peripheral Artery Disease andother vascular disorders. Resverlogix Corp.'s common shares trade on theToronto Stock Exchange (TSX:RVX). For further information please visit www.resverlogix.com.

Thisnews release may contain certain forward-looking information as definedunder applicable Canadian securities legislation, including ourstatements with respect to research, development and commercializationof novel therapeutics that reduce the risk of cardiovascular disease,the conduct of the ASSURE trial and statements contained herein that arenot based on historical fact, including without limitation statementscontaining the words "believes", "anticipates", "plans", "intends","will", "should", "expects", "continue", "estimate", "forecasts" andother similar expressions. Our actual results, events or developmentscould be materially different from those expressed or implied by theseforward-looking statements. We can give no assurance that any of theevents or expectations will occur or be realized. By their nature,forward-looking statements are subject to numerous known and unknownrisks and uncertainties including but not limited to those risk factorsdiscussed in the Company's Annual Information Form and January 31, 2011MD&A which are incorporated herein by reference and other documentswe file from time to time with securities authorities, which areavailable through SEDAR at www.sedar.com.The forward-looking statements contained in this news release areexpressly qualified by this cautionary statement are made as of the datehereof. The Company disclaims any intention and has no obligation orresponsibility, except as required by law, to update or revise anyforward-looking statements, whether as a result of new information,future events or otherwise.

%SEDAR: 00019253E

For further information:

Company Contact
Donald J. McCaffrey
President & CEO
Resverlogix Corp.
Phone: 403-254-9252
Email: Don@resverlogix.com US Institutional Investors
Susan Noonan
Managing Partner
S.A. Noonan Communications, LLC
Phone: 212-966-3650
Email: Susan@sanoonan.com
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