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Resverlogix Corp. (RVXCF)

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Last Post: 11/19/2018 8:17:04 AM - Followers: 25 - Board type: Free - Posts Today: 0

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.



Apabetalone (RVX-208) is a first-in-class small molecule that inhibits BET bromodomain proteins. The Phase 3 clinical trial BETonMACE is advancing with a primary endpoint of time to first occurrence of Major Adverse Cardiac Events (MACE) in high-risk cardiovascular disease (CVD) patients with type 2 diabetes mellitus and low high-density lipoprotein (HDL).

 
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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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#659  Sticky Note Zack's report on RVX! cabel 09/10/18 05:21:56 PM
#527  Sticky Note Upcoming catalysts and inflection points: ledrog_krill 07/10/18 05:54:04 AM
#774   2 out of 3 noretreat 11/19/18 08:17:04 AM
#773   NR, So what do you think our chances are cabel 11/19/18 08:04:22 AM
#772   possibly. (it's not like I'm planning to noretreat 11/19/18 07:52:28 AM
#771   True but reaching the 250 MACE events signals Matagordaville 11/18/18 09:48:45 PM
#770   Both the 250 MACE and the 8th DSMB noretreat 11/18/18 03:55:31 PM
#769   I think a 8th DSMB report is possible.... ledrog_krill 11/18/18 12:12:50 AM
#768   They will PR when they reach the required Matagordaville 11/17/18 06:51:23 PM
#767   Unlikely to be big news here until the noretreat 11/17/18 06:32:27 PM
#766   November Corporate Slide Deck——> https://www.resverlogix.com/upload/media_eleme Matagordaville 11/14/18 08:09:19 PM
#765   https://www.resverlogix.com/upload/media_element/148/3cada052755f/aha-2018-vascu Matagordaville 11/14/18 08:02:57 PM
#764   Nice,... looking forward to December! cabel 11/13/18 10:21:00 AM
#763   US side RVXCF Matagordaville 11/13/18 10:17:45 AM
#762   On the bid on the CDN or US side,...? cabel 11/13/18 10:10:02 AM
#761   50,000 on the bid. Big PR after thanksgiving..? Matagordaville 11/13/18 09:47:24 AM
#760   Game changing technology. Impressive write up. Ready Matagordaville 11/03/18 05:44:26 PM
#759   Resverlogix Closes $13.5 Million Private Placement noretreat 11/03/18 05:29:04 PM
#758   I am hopeful. It would be nice noretreat 11/02/18 11:52:19 AM
#757   Time to break the usual trend? ledrog_krill 11/02/18 10:40:57 AM
#756   Time to get in or add, IMO. noretreat 11/02/18 07:33:40 AM
#755   It's Canadian dollar $30, not USD. lousy engineer 11/01/18 10:07:39 PM
#754   It is an absolute must read. Matagordaville 11/01/18 09:48:53 PM
#753   Totally,... alot of detail,... well explained,... goes into cabel 11/01/18 09:30:55 PM
#752   That is an incredible analysis on RVXCF Matagordaville 11/01/18 09:27:53 PM
#751   RVX potential buyout projectio $30 USD,.. cabel 11/01/18 07:27:59 PM
#750   I am not very good at trading,... i cabel 11/01/18 05:55:23 PM
#749   I think the pattern is being noticed by ledrog_krill 11/01/18 03:37:34 PM
#748   Then you could choose to add on the noretreat 11/01/18 02:52:52 PM
#747   That's the one i am talking about, .. cabel 11/01/18 02:17:46 PM
#746   watch the price on the higher volume TSX. noretreat 11/01/18 01:55:35 PM
#745   Everyday it trades lower on low volume,... almost cabel 11/01/18 10:18:13 AM
#744   I agree. NASDAQ listing is sorely needed... noretreat 10/31/18 02:13:06 PM
#743   Not having any impact.... ledrog_krill 10/31/18 01:57:33 PM
#742   Interesting. https://www.streetwisereports.com/article/2018/10/31/biotech-s-lea noretreat 10/31/18 12:46:10 PM
#741   New SA blog posting: ledrog_krill 10/30/18 04:24:22 AM
#740   Roth....Rothschild Wonder if there's any connection....has me wondering if ledrog_krill 10/30/18 01:06:18 AM
#739   “... C$10 price target” RVXCF getting ready Matagordaville 10/29/18 09:49:30 PM
#738   Resverlogix (TSX: RVX) has received a rating update noretreat 10/29/18 04:08:18 PM
#737   Roth analyst initiates with $10 CDN target: ledrog_krill 10/29/18 01:42:58 PM
#736   $5 is the Rubicon..... ledrog_krill 10/28/18 05:03:44 PM
#735   Third qtr institutional holdings data just came out noretreat 10/28/18 03:55:53 PM
#734   Once we make the move to the Nasdaq Matagordaville 10/28/18 10:10:27 AM
#733   I have a very jaded view of the market.... ledrog_krill 10/28/18 01:12:11 AM
#732   Excellent! 60+ days away, but I expect some Matagordaville 10/26/18 10:29:44 PM
#731   A bargain at twice the price.... noretreat 10/26/18 07:34:09 PM
#730   I grabbed 1,000 more yesterday.... ledrog_krill 10/26/18 06:51:29 PM
#729   I expect to meet with mgmt in early noretreat 10/26/18 07:49:27 AM
#728   “.. reach the 250 MACE events.” I think that Matagordaville 10/25/18 02:29:11 PM
#727   I might. watching closely. noretreat 10/23/18 04:05:38 PM
#726   I hope you got some near the low,.. cabel 10/23/18 04:05:30 PM
#725   I added today. Matagordaville 10/23/18 02:24:15 PM
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