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Resverlogix Corp. (RVXCF)

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Resverlogix Corp., a biotechnology company, engages in the development of novel therapies for cardiovascular disease (CVD), cancer, and fibrotic diseases. The company's development programs include NexVas Plaque Regression, a technology platform, which is in two Phase 2b clinical trials with RVX-208 for the development of drugs that increase ApoA-I to reduce the risk of CVD; and IL-6 and IL-17, which are cytokine mediators for the treatment of autoimmune diseases, as well as technology for the development of drugs in the areas of multiple sclerosis and rheumatoid arthritis. Its development programs also include NexVas Alzheimer's Disease that focuses on the effects of ApoA-I production on cognition; memory; and both plasma and cerebrospinal fluid biomarkers, such as Amyloid Beta 40, 42, tau, and P-tau; and ReVas, a research stage technology for the development of therapeutics to be used with medical devices for the treatment of cardiovascular diseases. The company is headquartered in Calgary, Canada.


CARDIOVASCULAR DISEASE & ATHEROSCLEROSIS
Atherosclerosis is the key underlying cause of cardiovascular disease (CVD) which is responsible for more than 18 million deaths per year worldwide. Atherosclerosis burden results from the accumulation of fat and cholesterol in the artery wall, leading to plaque that causes narrowing and hardening of the arteries, resulting in a loss of elasticity and function. The projected direct and indirect medical costs of CVD in the U.S. will grow from $500 billion in 2012 to $1.2 trillion by 2030 and the largest percentage of this cost is associated with the treatment of atherosclerosis.
The image below illustrates the progression of atherosclerosis in CVD patients. As the disease progresses, the patient develops more severe coronary artery disease (CAD) resulting in increased risk of morbidity and death.


APOA-I, HDL AND REVERSE CHOLESTEROL TRANSPORT

APOA-I AND HDL

Please mouse over the interactive image to learn about the ApoA-I/HDL Particle.
 

The most abundant protein in HDL is ApoA-I and it serves as the building block for high-density lipoprotein (HDL or the "good cholesterol") particles. Increased production of ApoA-I protein will result in the synthesis of new HDL particles. These newly synthesized HDL particles are more' functional' because of their ample capacity to remove cholesterol from atherosclerotic plaques. The efflux of cholesterol from the plaque to HDL is called reverse cholesterol transport (RCT). The goal of enhanced RCT with newly synthesized HDL is to remove cholesterol from plaque in the arteries, subsequently regressing atherosclerosis. ApoA-I production therapeutics are the only technologies to date to efficiently remove and regress atherosclerotic plaque in high risk CVD patients.

REVERSE CHOLESTEROL TRANSPORT

Reverse cholesterol transport (RCT) is the natural process within the body that describes how HDL removes cholesterol from atherosclerotic plaques found in the wall of arteries. Cholesterol removed from the plaque is transported on the HDL particle to the liver for excretion from the body in the bile. Newly synthesized HDL particles are flat and empty and thus have the most function in mediating RCT.



RVX-208 & MOA

RVX-208

RVX-208 is a first-in-class, small molecule that inhibits BET bromodomains. It is currently being evaluated in a phase 2b clinical trial for its ability to reverse and/or stabilize atherosclerotic disease. RVX-208 acts to increase the production of ApoA-I protein which in turn is used to make new high-density lipoprotein (HDL) particles. These functional HDL particles are flat and empty and can efficiently remove 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.

MECHANISM OF ACTION

RVX-208 acts via an epigenetic mechanism leading to enhanced activity of the ApoA-I gene resulting in increased production of the protein. RVX-208 works by binding to a target called a BET protein. Within the BET protein there are two specialized regions known as bromodomains. Each bromodomain can recognize and bind to an acetylated lysine. This modified amino acid is found in histones bound to DNA. When a BET protein, through the actions of a bromodomain, finds an acetylated lysine and binds to it, this epigenetic process is called 'reading'. When RVX-208 binds to the BET protein, it triggers a cascade of events leading to increased ApoA-I gene transcription and eventually production of the protein. RVX-208 is the first in this class of compounds to enter into clinical development. Clinical experience with RVX-208 demonstrates that BET inhibitors can be both safe and efficacious when given chronically.



CLINICAL DEVELOPMENT

RVX-208 has successfully completed a Phase 2b clinical trial 'SUSTAIN' and a second Phase 2b trial 'ASSURE' is ongoing.

SUSTAIN

In this Phase 2b clinical trial of 176 patients with established atherosclerotic CVD, RVX-208 significantly increased HDL-C, the primary endpoint. SUSTAIN also successfully met secondary endpoints, showed increases in levels of Apo-AI and large HDL particles, both believed to be important factors in enhancing reverse cholesterol transport activity. The SUSTAIN trial also showed that RVX-208 was safe when given daily for 6 months and increases in alanine aminotransferase (ALT) reported in previous trials were infrequent and transient with no new increases observed beyond week 12 of the 24-week trial.

ASSURE

ASSURE is a Phase 2b clinical trial that will evaluate the ability of RVX-208, to regress atherosclerotic disease versus placebo using intravascular ultrasound (IVUS) technology in patients with high-risk CVD. ASSURE is a 26-week, multi-center, double-blind, randomized, parallel group, placebo-controlled clinical trial. The primary trial endpoint will be the change in percent atheroma volume from baseline to 26 weeks measured by IVUS. Secondary objectives for ASSURE are evaluating the safety and tolerability of RVX-208 and effects of RVX-208 on HDL and non-HDL lipid parameters. IVUS technology will also be used to evaluate the changes in plaque stability, an important factor affecting risk of myocardial infarction. Over 310 patients have been enrolled of which 25% will receive placebo and 75% given 100 mg of RVX-208 twice daily.

ASSURE enrollment was completed September 2012. Data is expected in the first half of 2013.

All clinical trials are led by the Cleveland Clinic.

FUTURE DEVELOPMENT OF RVX-208

Following the phase 2b program, phase 3 clinical outcomes trials are planned. They will encompass high risk patients with coronary artery disease and with low baseline HDL. In addition, these patients will have at least one more risk factor such as diabetes, smoking or high blood pressure. These trials are often designed with a certain number of events to be observed such as cardiovascular death, non-fatal myocardial infarction, stroke or re-vascularization.

 
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RVXCF News: Resverlogix Officially Attains Phase 3 Status With a European Regulatory Authority 06/22/2015 07:30:00 AM
RVXCF News: Resverlogix and China-based Shenzhen Hepalink Pharmaceutical Co., Ltd. Announce a Combination Licensing and Equity Arrangemen... 04/27/2015 07:00:00 AM
RVXCF News: Week In Review: aTyr Pharma To Raise $86 Million In IPO 04/12/2015 06:07:02 AM
RVXCF News: Resverlogix Receives Two Patents for RVX-208 in China 04/07/2015 07:30:00 AM
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#527  Sticky Note Upcoming catalysts and inflection points: ledrog_krill 07/10/18 05:54:04 AM
#535   https://investingnews.com/daily/life-science-investing/biotech-investing/new-fin Matagordaville 07/20/18 02:16:40 PM
#534   Added a few today. Ready for news Matagordaville 07/19/18 12:30:16 PM
#533   Resverlogix Announces Upcoming Presentations at Clinical Trials in noretreat 07/17/18 07:49:46 AM
#532   June 2018 Corporate Update https://www.resverlogix.com/upload/media_element/123/ Matagordaville 07/11/18 08:36:17 AM
#531   Sample Size Recalculation Analysis.... ledrog_krill 07/11/18 08:07:04 AM
#530   SSRA means what, can't find it with google. Thanks! cabel 07/11/18 07:00:21 AM
#529   Bought some today and this puppy wanted to Matagordaville 07/10/18 10:43:02 PM
#528   Excellent post. This should be a sticky for Matagordaville 07/10/18 10:40:17 PM
#527   Upcoming catalysts and inflection points: ledrog_krill 07/10/18 05:54:04 AM
#526   This is going to 10 bucks with decent noretreat 07/09/18 04:43:07 PM
#525   Interesting day here. Will the shorts appear? Matagordaville 07/09/18 03:24:25 PM
#524   RVX.TO had its Golden Cross already..... ledrog_krill 07/09/18 12:29:47 PM
#523   52 week high today $2.06 $RVXCF Matagordaville 07/09/18 09:54:53 AM
#522   Golden Cross time, 50/200 DMAs trending higher: ledrog_krill 07/05/18 08:28:28 PM
#521   All eyes on Canada for the 4th of July..... ledrog_krill 07/04/18 04:16:29 AM
#520   Thanks. Informative noretreat 07/03/18 10:41:21 AM
#519   Sat on the 1.67-1.68 bid for a few Matagordaville 07/02/18 02:33:50 PM
#518   I don't have much faith in L-II quotes.... ledrog_krill 06/29/18 02:27:34 AM
#517   I don't have much faith in L-II quotes.... ledrog_krill 06/29/18 02:27:11 AM
#516   June 14, 2018 RESVERLOGIX ANNOUNCES FDA CONFIRMATION REGARDING FILING Matagordaville 06/28/18 01:59:01 PM
#515   If the 20,000 on the ask at 1.86 Matagordaville 06/28/18 01:27:00 PM
#514   Its like the damn has to burst one ledrog_krill 06/27/18 10:39:48 AM
#513   this is one of those that will soon noretreat 06/27/18 07:42:07 AM
#512   I put an order in at the Ask Matagordaville 06/26/18 03:58:51 PM
#511   I grabbed some today. Would be nice Matagordaville 06/26/18 03:37:17 PM
#510   Volume uptick today. Matagordaville 06/26/18 11:33:59 AM
#509   Good on ya for that...I saw your posts ledrog_krill 06/24/18 09:52:02 PM
#508   I’m with you. I used the run up noretreat 06/24/18 09:17:58 PM
#507   I like the chances for a big move ledrog_krill 06/24/18 08:02:48 PM
#506   Motley Fool - Resverlogix one of three biotechs noretreat 06/24/18 04:49:15 PM
#505   Looks great Top Stock Picks 06/23/18 09:03:13 AM
#504   Motley Fool Exposure.... ledrog_krill 06/23/18 04:55:58 AM
#503   Thumbs up. I wonder when this will Matagordaville 06/21/18 04:14:24 PM
#502   i finished my flip yesterday. Will buy noretreat 06/21/18 04:09:38 PM
#501   Hard to know if they would give someone Matagordaville 06/21/18 04:05:15 PM
#500   shades of nerby??? I dunno, what do noretreat 06/21/18 04:00:38 PM
#499   Is now the time to be adding here? Matagordaville 06/21/18 01:47:51 PM
#498   Posted on another board this morning. If noretreat 06/21/18 09:01:48 AM
#497   Excellent.....trying to be patient. Matagordaville 06/19/18 09:30:12 PM
#496   Got almost 40 cents on the flip. Lowered noretreat 06/19/18 08:03:12 PM
#495   From 2.00 down to the 1.50’s this puppy Matagordaville 06/19/18 01:50:39 PM
#494   sold 25% near 2 bucks...should be able to noretreat 06/19/18 12:54:27 PM
#493   not to my knowledge. the focus is noretreat 06/18/18 04:31:29 PM
#492   Does management have a plan in place to Matagordaville 06/18/18 01:50:45 PM
#491   Someone had around 70k on the ask earlier ..... Matagordaville 06/18/18 01:30:37 PM
#490   lol at the other board... noretreat 06/17/18 06:05:11 PM
#489   Analysis Focus: RVXCF noretreat 06/16/18 11:39:34 AM
#488   Naked short selling can pummel a stock.... ledrog_krill 06/16/18 06:54:46 AM
#487   Buy the dips strategy continues to work spectacularly here. noretreat 06/15/18 10:49:45 AM
#486   Down the tubes lately. Any rumors? noretreat 06/01/18 08:06:45 AM
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