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Resverlogix Corp. (RVXCF)

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Last Post: 11/23/2016 1:53:39 PM - Followers: 22 - 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
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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
#338   Right...no definite time to completion. noretreat 11/23/16 01:53:39 PM
#337   Right...no definite time to completion. noretreat 11/23/16 01:53:38 PM
#336   The trial is events based..... ledrog_krill 11/23/16 11:27:58 AM
#335   The AGM is December 15th. Look for noretreat 11/23/16 11:25:38 AM
#334   NR, When do you think the next big update cabel 11/23/16 09:55:43 AM
#333   The studies referenced here suggest to me that noretreat 11/22/16 04:25:36 PM
#332   Things look delayed re the added partnership. noretreat 11/19/16 12:57:07 PM
#331   That would not sit well with me...... ledrog_krill 11/15/16 01:15:05 AM
#330   Further delay is a distinct possibility as well. noretreat 11/14/16 06:25:25 PM
#329   One day more.... ledrog_krill 11/14/16 02:02:14 PM
#328   What you said is all too true. someconcerns 11/14/16 12:19:51 PM
#327   There's a lot of manipulation out there...... ledrog_krill 11/13/16 09:32:31 PM
#326   I'm constantly amazed at the variety of places someconcerns 11/13/16 09:22:36 PM
#325   Some discussion at Agora and here.... ledrog_krill 11/13/16 09:18:08 PM
#324   And I guess I can confirm that investors someconcerns 11/13/16 08:49:18 PM
#323   Who knows what will happen? I can noretreat 11/13/16 08:20:15 PM
#322   My crystal ball is cloudy. Onlytime will someconcerns 11/13/16 07:10:26 PM
#321   I doubt they'd acquire Reserlogix... ledrog_krill 11/13/16 07:01:39 PM
#320   Well, as the Novo video stated they would someconcerns 11/13/16 06:32:42 PM
#319   Agoracom.com is the most active RVX forum.... ledrog_krill 11/13/16 06:18:01 PM
#318   Will check it out. Agoracom ihub page? someconcerns 11/13/16 02:16:14 PM
#317   Have you heard the NovoNordisk rumors? (agoracom thread) noretreat 11/13/16 02:03:44 PM
#316   Good note on your blog. Thanks to someconcerns 11/12/16 04:57:49 PM
#315   The good news is coming and when the noretreat 11/12/16 08:01:48 AM
#314   I was out today...... ledrog_krill 11/11/16 11:01:33 PM
#313   I bought some more today noretreat 11/11/16 07:08:29 PM
#312   Thanks for sharing it noretreat.... ledrog_krill 11/11/16 04:41:46 PM
#311   Everyone here may be interested in your new noretreat 11/11/16 08:30:13 AM
#310   Much better humor really everywhere other than the noretreat 11/05/16 02:54:44 PM
#309   The standards for sense of humor may be scottsmith 11/03/16 03:53:08 PM
#308   It WAS a joke. Really it is someconcerns 11/03/16 03:42:06 PM
#307   My what? ledrog_krill 11/03/16 03:38:35 PM
#306   You could use your extensive connections over there someconcerns 11/03/16 03:36:33 PM
#305   Still waiting to find out........... ledrog_krill 11/03/16 01:42:18 PM
#304   I'll go with imminent.... and hope that's the case. someconcerns 11/03/16 11:48:03 AM
#303   2nd partner announcement is either imminent or past noretreat 11/02/16 09:28:32 AM
#302   Thanks. incubus-now 10/18/16 10:17:57 PM
#301   Resverlogix update: someconcerns 10/18/16 07:55:21 PM
#300   I agree. Same with all small caps incubus-now 10/12/16 04:22:03 PM
#299   to your pm I agree. tiny volumes noretreat 10/12/16 04:16:32 PM
#298   Mid to Late 2017 should be a pivotal noretreat 10/10/16 04:35:54 PM
#297   Early negotiations for a partnership or buyout could someconcerns 10/07/16 01:28:08 PM
#296   Well, that's one less concern :-) ledrog_krill 10/07/16 12:50:36 AM
#295   TORONTO, Oct. 6, 2016 /CNW/ - Resverlogix Corp. someconcerns 10/06/16 06:33:27 PM
#294   The futility analysis is huge imo ledrog_krill 10/06/16 01:47:47 PM
#293   I buy on the OTC. You are noretreat 10/06/16 08:56:15 AM
#292   Are you using the OTC or TSX? ledrog_krill 10/05/16 08:51:21 PM
#291   3 bucks Canadian is just a starting point noretreat 10/05/16 03:26:57 PM
#290   ..and the run resumes nicely after my reload. noretreat 10/05/16 03:22:47 PM
#289   And a Golden Cross to boot.... ledrog_krill 10/04/16 07:45:21 PM
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