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Resverlogix Corp. (RVXCF)

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Last Post: 9/24/2016 12:06:44 PM - Followers: 23 - 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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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
PostSubject
#284   It sure does. Or even just regular scottsmith 09/24/16 12:06:44 PM
#283   The final numbers on TMX came back up incubus-now 09/24/16 11:46:32 AM
#282   Opened Mon Sept 19th at $1.15.... ledrog_krill 09/24/16 05:07:03 AM
#281   I guess the stock took a long weekend off. someconcerns 09/23/16 08:16:18 PM
#280   Nothing wrong with that. TMX now shows incubus-now 09/23/16 03:47:31 PM
#279   that was me just now with the 5k. noretreat 09/23/16 03:43:46 PM
#278   Looking at TMX, we should be at 1.39. incubus-now 09/23/16 03:35:23 PM
#277   Interesting to see the 0.06+ drop on one, incubus-now 09/23/16 02:57:11 PM
#276   This action is just manipulation. Low volume noretreat 09/23/16 02:42:01 PM
#275   Hopefully it will take off right after that,... cabel 09/23/16 02:39:41 PM
#274   The first gap just filled...I think there are noretreat 09/23/16 02:24:00 PM
#273   What I like are the international ties that incubus-now 09/23/16 12:33:32 PM
#272   Thanks for your help. cabel 09/23/16 08:31:18 AM
#271   The RSI wont hold this level. Would noretreat 09/23/16 08:28:54 AM
#270   I guess you have or are getting ready cabel 09/23/16 08:24:45 AM
#269   Great results indeed. Is it overbought? noretreat 09/23/16 08:23:04 AM
#268   Not bad. Good September. incubus-now 09/22/16 03:28:35 PM
#267   167k us shares so far today, by far noretreat 09/22/16 02:07:59 PM
#266   Clearly this RSI (85!) will not be sustained...it noretreat 09/22/16 02:00:12 PM
#265   That's crazy. My wife is from Edmonton. incubus-now 09/22/16 01:33:37 PM
#264   This country is nuts sometimes.... ledrog_krill 09/22/16 01:23:12 PM
#263   That's true. My wife is Canadian and incubus-now 09/22/16 12:52:06 PM
#262   I show volume at over 160,000.... ledrog_krill 09/22/16 12:42:27 PM
#261   2.16 - 81,163 at this point. On incubus-now 09/22/16 12:39:38 PM
#260   Yesterday at lunch time.... ledrog_krill 09/22/16 11:48:16 AM
#259   deal coming imo noretreat 09/22/16 10:35:57 AM
#258   Thought the phase 3 status in Europe was incubus-now 09/22/16 10:20:01 AM
#257   not here. noretreat 09/22/16 08:10:09 AM
#256   You taking some profits here,...? cabel 09/21/16 04:52:44 PM
#255   Nice! scottsmith 09/21/16 04:19:12 PM
#254   67% on my giant pile of shares. Hmmmm.... noretreat 09/21/16 04:16:05 PM
#253   Its been in beast mode since the 9th.... ledrog_krill 09/21/16 10:44:29 AM
#252   Looks very interesting. But would hate to scottsmith 09/21/16 09:45:55 AM
#251   RVX chart is looking very strong. Some noretreat 09/21/16 05:22:53 AM
#250   New Blog posting.... ledrog_krill 09/15/16 11:39:56 PM
#249   Grossly undervalued? ledrog_krill 09/15/16 03:12:15 PM
#248   Quoted from the R&R presentation: Best noretreat 09/14/16 08:36:15 PM
#247   volume picking up along with price...two signs of life. noretreat 09/14/16 08:28:23 PM
#246   88,400 traded in Canada.... ledrog_krill 09/14/16 05:22:12 PM
#245   moving up a bit more today, this time noretreat 09/14/16 04:24:44 PM
#244   bit of a move up here ... on noretreat 09/13/16 08:13:55 PM
#243   good question...perhaps by year-end. noretreat 06/20/16 04:21:56 PM
#242   when is the interim data to be release? big orange 06/20/16 10:08:25 AM
#241   Resverlogix Announces Corporate Update Webcast someconcerns 06/09/16 03:32:44 PM
#240   When is the interim data to be released big orange 06/07/16 05:47:45 PM
#239   Thanks for the notes, NR someconcerns 05/07/16 02:30:23 PM
#238   repost from elsewhere: noretreat 05/02/16 06:57:03 AM
#237   Still a good price but there is a incubus-now 05/01/16 04:05:14 AM
#236   Hey Incubus-see previous post. IDK why things noretreat 04/30/16 12:59:47 PM
#235   tip toeing up on tiny volume. done noretreat 04/30/16 12:55:30 PM
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