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Resverlogix Corp. (RVXCF)

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Last Post: 5/16/2019 10:40:09 PM - Followers: 29 - 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
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#889  Sticky Note IMPORTANT! Resverlogix’ BETonMACE Phase 3 Trial Successfully noretreat 04/18/19 10:55:42 AM
#659  Sticky Note Zack's report on RVX! cabel 09/10/18 05:21:56 PM
#527  Sticky Note Upcoming catalysts and inflection points: growacet 07/10/18 05:54:04 AM
#963   New SA Blog post on the drop.... growacet 05/16/19 10:40:09 PM
#962   Short update on Wednesday, my bad............ growacet 05/16/19 02:49:19 AM
#961   If we'd know the at market proposed offering growacet 05/15/19 11:34:45 PM
#960   big gap to fill...and they almost always do fill! noretreat 05/15/19 04:39:56 PM
#959   well the drop today put us back to noretreat 05/15/19 04:39:25 PM
#958   How much further do you anticipate this breakdown Phoenix300 05/15/19 04:20:25 PM
#957   offer will likely have to be pulled. noretreat 05/15/19 04:05:11 PM
#956   me too on the "could have played it noretreat 05/15/19 12:58:01 PM
#955   Down nearly 20% today but holding there. Phoenix300 05/15/19 12:35:44 PM
#954   New SA blog post on the "proposed" offering.... growacet 05/15/19 12:38:39 AM
#952   Meh.....could have played it better growacet 05/10/19 12:35:06 PM
#951   Nice move congrats Phoenix300 05/10/19 12:14:53 PM
#950   that was a wise decision! noretreat 05/10/19 09:49:37 AM
#949   Resverlogix Keeps Climbing - How High Can It Go? noretreat 05/09/19 08:41:45 AM
#948   New SA blog post on Resverlogix? growacet 05/09/19 01:18:11 AM
#947   I'm falling in love with biotech plays..... growacet 05/08/19 05:41:19 PM
#946   Cool. I'm pretty much a biotech investor. noretreat 05/08/19 03:56:01 PM
#945   Chickened out and bought them back.... growacet 05/08/19 03:38:17 PM
#944   I started buying in Jan 2014.... growacet 05/08/19 03:18:50 PM
#943   I bought most of my shares at 40-50cents us noretreat 05/08/19 03:13:39 PM
#942   What pushed me over..... growacet 05/08/19 03:01:33 PM
#941   I thought about it for a few minutes noretreat 05/08/19 02:41:43 PM
#940   I thought about it for a few minutes noretreat 05/08/19 02:41:42 PM
#939   I play the same way. No more noretreat 05/08/19 02:24:19 PM
#938   RSI is getting up there Phoenix300 05/08/19 02:09:54 PM
#937   $5 CDN and then fade? growacet 05/08/19 01:57:03 PM
#936   It will definitely look like a little rally noretreat 05/08/19 01:12:57 PM
#935   Calling this a "little rally" growacet 05/08/19 11:26:41 AM
#934   It’s showing some legs Phoenix300 05/08/19 10:00:15 AM
#933   This is a nice little rally anticipating results. noretreat 05/08/19 09:59:35 AM
#932   Indeed. Solid. Phoenix300 05/06/19 05:25:25 PM
#931   This is the kind of thing that IPIX noretreat 05/06/19 03:40:44 PM
#930   Resverlogix Announces Publication on Apabetalone in High-Impact American Phoenix300 05/06/19 08:50:55 AM
#929   Volume will tell the tale I believe.... growacet 05/03/19 09:20:17 AM
#928   I hope you are right about the run-up, noretreat 05/03/19 09:08:08 AM
#927   a substantial upside from the current share price growacet 05/03/19 07:51:31 AM
#926   "In determining the valuation of the Company, we noretreat 05/03/19 07:15:24 AM
#925   Third Eye has to be thrilled.... growacet 05/02/19 09:36:47 PM
#924   The reduced cash requirement is not surprising given noretreat 05/02/19 09:19:26 PM
#923   Kicking the can down the road. And noretreat 05/02/19 09:18:32 PM
#922   And the news is, loan extended 3 months.... growacet 05/02/19 05:20:33 PM
#921   Resverlogix Announces 3-Month Loan Extension CALGARY, Alberta, May 02, Phoenix300 05/02/19 05:15:50 PM
#920   History does tend to repeat. Tediously, perhaps, but noretreat 05/02/19 04:17:40 PM
#919   Back to watching the paint dry.... growacet 05/02/19 03:01:52 PM
#918   Coverage, today's date: growacet 05/01/19 03:23:18 PM
#917   Volume grinding to almost nothing.... growacet 04/30/19 10:00:01 AM
#916   I agree that as the price moves up cabel 04/30/19 08:10:16 AM
#915   There are probably many who, like you, look noretreat 04/30/19 07:50:30 AM
#914   NR, Preapare for the worst but hope for the cabel 04/30/19 07:09:55 AM
#913   I wasn't around for the Assure trial failure.... growacet 04/29/19 10:29:39 PM
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