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Resverlogix Corp. (RVXCF)

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Last Post: 9/17/2017 12:18:12 PM - Followers: 20 - 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.

 
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PostSubject
#416   Blog post about Biopharm America Attendance ledrog_krill 09/17/17 12:18:11 PM
#415   The deal for all or most of RVX noretreat 09/07/17 11:58:15 AM
#414   There had to be some sort of offset noretreat 08/28/17 09:42:48 AM
#413   Good news,.. liked the part about a possible cabel 08/28/17 08:58:00 AM
#412   Resverlogix Announces Extension of Maturity Date of Loan noretreat 08/28/17 07:24:38 AM
#411   Never all in. on anything. thinking noretreat 08/25/17 12:49:35 PM
#410   So are you all in or all out cabel 08/24/17 01:37:08 PM
#409   loan goes default on Monday without intervention. noretreat 08/24/17 01:32:00 PM
#408   10 days until the loan is due. noretreat 08/18/17 04:17:32 PM
#407   zzzzzzzzz....waiting for word on the loan. noretreat 08/07/17 04:11:35 PM
#406   Great news! someconcerns 07/25/17 09:27:27 AM
#405   Important! NEWS noretreat 07/25/17 09:02:31 AM
#404   Trading halt this morning. My guess is noretreat 07/25/17 08:53:57 AM
#403   It has to be resolved...one way or t'other ledrog_krill 07/24/17 03:15:00 PM
#402   The suspense over the big loan coming due noretreat 07/23/17 09:00:28 PM
#401   With the current financial burn does the company big orange 06/15/17 04:57:02 PM
#400   Futility analysis is due approximately in August. The noretreat 06/13/17 08:46:36 PM
#399   When is the interim data to be published big orange 06/13/17 04:45:26 PM
#398   Thoughts on the fly by night financing? scottsmith 06/11/17 09:43:14 AM
#397   overnight financing. raised up to 10 million. noretreat 06/09/17 04:27:46 PM
#396   What happened to the price this morning,..? cabel 06/09/17 01:44:52 PM
#395   New Blog Post Up at ATB ledrog_krill 05/28/17 08:32:06 PM
#394   Agreed. Not some interested in their SP calls, MrW 05/03/17 05:49:25 PM
#393   I don't take any advice from any website. noretreat 05/03/17 05:39:17 PM
#392   It's the first time I had seen it MrW 05/03/17 05:31:31 PM
#391   No. What do you think of them? noretreat 05/03/17 05:30:26 PM
#390   Thanks for the link, NR. Are you a MrW 05/03/17 05:16:38 PM
#389   Here's something: $1.44 to 10 bucks plus?? noretreat 05/02/17 06:05:30 AM
#388   I expect soft share price here until the noretreat 04/24/17 09:12:18 PM
#387   The futility analysis is "due" in early summer. noretreat 04/07/17 08:34:22 AM
#386   When is the interim data for the phase big orange 04/06/17 11:23:43 AM
#385   Don't forget to vote again today... ledrog_krill 04/05/17 11:02:47 AM
#384   Done! cabel 04/04/17 06:21:49 PM
#383   Up for "Pipelines of Promise" Award...based on votes ledrog_krill 04/04/17 06:09:31 PM
#382   http://adpd2017.kenes.com/scientific-information/interactive-program-2#.WNvqFVUr Bandage 03/29/17 01:12:12 PM
#381   NR, Nice movement again today,... are you hearing anything,..? Thanks cabel 03/16/17 05:35:35 PM
#380   News Release Issued: Mar 15, 2017 (5:00am MDT) noretreat 03/15/17 08:45:01 AM
#379   This is one of my larger positions, especially noretreat 03/10/17 12:40:30 PM
#378   NR, Just curious,... do you have more here that cabel 03/10/17 11:18:53 AM
#377   Increased my position today,... looks like it wants cabel 03/01/17 03:50:54 PM
#376   My understanding is that they are in many noretreat 03/01/17 03:39:21 PM
#375   I have seen the presentations and the talks Bandage 03/01/17 01:37:56 PM
#374   This one is about to blow up. Phase /// lyn_cominser 02/28/17 11:10:55 PM
#373   BETonMACE is recruiting at over 20 sites in noretreat 02/28/17 04:41:42 PM
#372   Is the current RVX-208 Phase III trial only Bandage 02/28/17 02:15:02 PM
#371   New article...Please read this! noretreat 02/27/17 12:25:10 PM
#370   Reservologix met with the FDA to redesign the bbhuey 02/24/17 12:04:33 PM
#369   Apabetalone May Repress Toxic Gene in Rare Muscular noretreat 02/20/17 11:28:49 AM
#368   With all the indications that this drug seems bbhuey 02/16/17 07:27:22 AM
#367   Resverlogix Highlights Unique Properties of Apabetalone in Both noretreat 02/13/17 07:43:53 AM
PostSubject