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Resverlogix Corp. (RVXCF)

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Last Post: 1/11/2019 9:29:15 PM - 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: growacet 07/10/18 05:54:04 AM
#832   There is nothing more I can say at noretreat 01/11/19 09:29:15 PM
#831   NR, Did you have a chance to talk to cabel 01/11/19 11:38:50 AM
#830   NR, Did you have a chance to talke to cabel 01/11/19 11:38:49 AM
#829   The only other comment I have for now noretreat 01/08/19 06:55:30 PM
#828   Was there alot in attendance at their presentation,... cabel 01/08/19 12:23:54 PM
#827   Any tidbit on financing,..? cabel 01/08/19 12:01:40 PM
#826   After the topline. Second half would be my guess. noretreat 01/08/19 11:04:48 AM
#825   Thanks,... any word on how they will get cabel 01/08/19 10:46:38 AM
#824   The longer it takes the lower the rate noretreat 01/08/19 10:42:12 AM
#823   The presentation is there but very little has cabel 01/08/19 10:21:11 AM
#822   Indeed, new Corporate Presentation Jan-2019 https://www.resverlogix.com/upload/e Matagordaville 01/08/19 10:19:01 AM
#821   I bet it is on their web site. noretreat 01/08/19 10:13:50 AM
#820   “BetOnMace seems a good bet based on the Matagordaville 01/08/19 10:03:31 AM
#819   Yes, it would be great to hear the cabel 01/08/19 08:57:17 AM
#818   Enjoy the morning coffee and keep the updates coming. Matagordaville 01/08/19 08:45:14 AM
#817   :) eeeeexcellent!!!! $$$ Matagordaville 01/07/19 09:06:05 PM
#816   Yes. noretreat 01/07/19 09:05:04 PM
#815   Can you share some of the things you cabel 01/07/19 08:50:39 PM
#814   You spoke with them today a little with Matagordaville 01/07/19 08:30:55 PM
#813   Can’t say for sure..... noretreat 01/07/19 08:29:39 PM
#812   BetOnMace seems a good bet based on the noretreat 01/07/19 08:18:13 PM
#811   The most important question: lousy engineer 01/07/19 07:44:43 PM
#810   Buyers were lurking and grabbing shares today. Matagordaville 01/07/19 07:32:18 PM
#809   Late day presentation 4 pm. I don’t noretreat 01/07/19 05:28:32 PM
#808   Also questions about their plans to uplist with cabel 01/07/19 04:57:13 PM
#807   NR, cabel 01/07/19 04:51:07 PM
#806   Impending announcement of going on NASDAQ soon? Matagordaville 01/07/19 04:40:26 PM
#805   Which questions? noretreat 01/07/19 04:39:33 PM
#804   Any chance to ask the questions to RVX cabel 01/07/19 04:27:58 PM
#803   Very good. When do you bump into Matagordaville 01/07/19 01:29:54 PM
#802   Nothing on RVX. Some interesting other opportunities noretreat 01/07/19 01:28:48 PM
#801   Is your radio working? Anything new on Matagordaville 01/07/19 01:22:17 PM
#800   Shares on the ASK are slowly being consumed. Matagordaville 01/07/19 11:17:12 AM
#799   There has been some buying at the ASK today. Matagordaville 01/07/19 11:13:29 AM
#798   RVX up nicely this morning,... $3.43 cabel 01/07/19 10:02:58 AM
#797   New RVXCF tweet Starting off 2019 with a new Matagordaville 01/07/19 09:30:48 AM
#796   Excellent. Special Agent NR is on the ground!!! Matagordaville 01/06/19 03:46:17 PM
#795   I’m there. Off to a productive start noretreat 01/06/19 11:09:22 AM
#794   Look forward to your report from the Biotech Showcase. Matagordaville 01/06/19 10:48:47 AM
#793   No problem. Lots of reversals this week. Things noretreat 01/04/19 06:36:52 PM
#792   noretreat, Looking forward to the questions you ask and cabel 01/04/19 06:33:32 PM
#791   RVXCF looking up again Matagordaville 01/04/19 06:31:49 PM
#790   I saw that....thanks. Stock is holding up noretreat 12/20/18 02:36:02 PM
#789   NR, Here are some questions that BearDownAZ posted on cabel 12/20/18 12:35:50 PM
#788   Sooner than I was thinking....all good growacet 12/19/18 09:16:46 PM
#787   “... Resverlogix has engaged Rothschild & Co. as Matagordaville 12/19/18 01:28:01 PM
#786   taking forever to get the needed MACE events. noretreat 12/19/18 10:22:00 AM
#785   "Following review of data from all 2,425 patients Matagordaville 12/19/18 08:55:35 AM
#784   Resverlogix Announces Eighth Positive Data Safety Monitoring Board Matagordaville 12/19/18 08:41:51 AM
#783   It was when you wrote that.... growacet 12/13/18 02:48:38 PM
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