Re: INFO RE FDA MEANS? SORRY OLD STUFF.
noretreat Saturday, 06/16/18 11:39:34 AM
Re: None 0
Post # of 989
Analysis Focus: RVXCF
Resverlogix (OTCPK:RVXCF) recently announced that the FDA has accepted the statistical analysis plan and endpoints for the large-scale Phase 3 trial of assessment of cardiovascular benefits of its lead candidate apabetalone. The projected endpoint of the study is the reduction of major adverse cardiovascular events (MACE) in a high cardiovascular risk in type 2 diabetes population. The same population often also displayed low levels of high density lipoproteins (HDL). FDA acceptance of these endpoint and plan of analysis of the impact on specific indication now takes the drug closer to NDA filing and approval.
In recent times there has been a lot of discussion on pros and cons of gene therapy techniques like CaS9. That technology is considered very effective for diseases caused by genetic disorders. True, there are close to 10K diseases which are caused by genetic disorders, but many times diseases are caused by a scenario when a perfectly healthy gene (which is uniformly present in all our body cells) starts behaving in disorderly ways because of external factors. This situation is called an epigenetic modification.
In particular, apabetalone (which was previously known as RVX-208) blocks one such epigenetic trigger in diseased cells called Bromodomain Extra-Terminal domain (BET) proteins. By blocking such a group of proteins which causes genetically healthy cells to behave as a diseased cell, apabetalone can thwart a lot of serious clinical conditions. A list of peer-reviewed scientific literature on various possibilities of such an epigenetic inhibitor can be found in this analysis. Some of the names of the diseases that stand out of the list include atherosclerosis, myocardial infarction, diabetic kidney disease, and rheumatoid arthritis.
However the clinical trials of apabetalone were primarily concerned with the capacity of BET inhibitors of improving the condition of high-risk cardiovascular disease patients. It has concluded all the three phases of clinical trial without any report of major adverse cardiovascular events (MACE). Current standard of care (SOC) for patients with high-risk cardiovascular diseases and low HDL is statin administration. Statins are around for a long time and in spite of their high reliability they can address ~30% of such CV events.