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Resverlogix Corp. (RVXCF)

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Last Post: 10/12/2019 1:32:12 PM - Followers: 28 - 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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PostSubject
#1050   And the FDA did agree to the protocol. noretreat 10/12/19 01:32:12 PM
#1049   Don't know what the protocol was for what big orange 10/12/19 01:08:52 PM
#1048   not making any big bets on it, but noretreat 10/10/19 04:03:01 PM
#1047   Hope you are right big orange 10/10/19 09:23:35 AM
#1046   Not necessarily as it is one of the noretreat 10/10/19 08:36:29 AM
#1045   Would require a stage three clinical trial before big orange 10/09/19 09:52:49 AM
#1044   May work better with Crestor than Lipitor. That noretreat 10/08/19 09:01:45 PM
#1043   Maybe to discuss the potential for this compound. big orange 10/07/19 11:06:11 PM
#1042   The 64k question is, why would AHA put biopa 10/05/19 12:55:58 AM
#1041   OTOH, there is much more information to come noretreat 10/03/19 10:28:43 AM
#1040   The facts are easy. It missed its primary noretreat 10/03/19 09:53:29 AM
#1039   What facts and rumors? big orange 10/02/19 09:50:12 PM
#1038   Endpoint not met. Very little cash. Facts. Rumors abound noretreat 10/02/19 07:46:20 PM
#1037   Why coming back so strong? Thought that big orange 10/02/19 06:30:06 PM
#1036   Fun times. Almost halfway back noretreat 10/02/19 06:10:36 PM
#1035   Why the pop in price? big orange 10/02/19 04:46:01 PM
#1034   Good point. Phoenix300 09/30/19 08:44:13 PM
#1033   short covering? possibly to be followed by noretreat 09/30/19 07:37:06 PM
#1032   “The market knew what was coming ...” It seemed Phoenix300 09/30/19 01:59:32 PM
#1031   Yes it’s too bad it wasn’t a success Phoenix300 09/30/19 01:58:26 PM
#1030   Realistically...the company has little chance of being able noretreat 09/30/19 10:38:07 AM
#1029   sucks big time. noretreat 09/30/19 10:35:25 AM
#1028   On your mark, get set, GO! Phoenix300 09/30/19 09:21:03 AM
#1027   BETonMACE did not meet the primary endpoint Apabetalone Phoenix300 09/30/19 07:46:20 AM
#1026   Resverlogix Announces Topline Results in BETonMACE Phase 3 Phoenix300 09/30/19 07:45:04 AM
#1025   Of course. Big flops are sometimes buried in noretreat 09/27/19 02:56:17 PM
#1024   Common sense. Data release just before conference big orange 09/27/19 12:38:00 PM
#1023   Common sense. Data release just before conference big orange 09/27/19 12:38:00 PM
#1022   hope it is not at 4:01 this afternoon.... noretreat 09/27/19 12:12:00 PM
#1021   the data release should come first. but noretreat 09/27/19 12:11:34 PM
#1020   The conference call is not the data release Phoenix300 09/27/19 08:48:12 AM
#1019   Here we go.... hope I have the noretreat 09/26/19 07:43:16 PM
#1018   Resverlogix to Host BETonMACE Webcast and Conference Call noretreat 09/26/19 07:42:33 PM
#1017   Yikes. I didn’t see this coming, Phoenix300 09/25/19 08:48:44 PM
#1016   Shouldn’t be. But who knows. Volume popped today noretreat 09/24/19 09:51:48 PM
#1015   Leak? Phoenix300 09/24/19 09:48:48 PM
#1014   I added a bit today noretreat 09/24/19 09:48:01 PM
#1013   Nosedive. Into data. Accelerating after database noretreat 09/24/19 09:47:33 PM
#1012   Getting close to the buy zone. Phoenix300 09/24/19 08:51:30 AM
#1011   Sure. Why not? The length of the noretreat 09/17/19 08:46:13 PM
#1010   Are we bullish on Sept 30th's results? jstiltz22 09/17/19 10:19:47 AM
#1009   Resverlogix Provides Update on BETonMACE Phase 3 Trial Top-line Phoenix300 09/16/19 08:36:10 AM
#1008   It could be a pivotal week for RVX. noretreat 09/15/19 01:45:33 PM
#1007   There's no volume.... growacet 08/12/19 11:00:10 AM
#1006   I agree. RVX to this point has noretreat 08/12/19 10:52:01 AM
#1005   Just using AMRN as a guide..... growacet 08/12/19 10:24:38 AM
#1004   This would be a good week to start noretreat 08/11/19 04:32:41 PM
#1003   FYI. There was too much fine print noretreat 08/09/19 07:17:42 PM
#1002   The 531K short figure.... growacet 08/09/19 04:34:37 PM
#1001   I noticed there are ~531K shares short as ramspower 08/09/19 04:28:49 PM
PostSubject