RSI/Pharmaceuticals - Unraveling The Mystery Of Diabetes
RSI/Pharmaceuticals is developing a new investigational drug technology (code-named INS2) that is presenting the ability to dramatically reduce the amount of insulin required by the human body to function in a normal, healthy manner. This includes the disease states of type 1 and type 2 diabetes, pre-diabetes, PCOS (polycystic ovarian syndrome), as well as other insulin resistant issues.
In limited human testing INS2 indicates a reduction in the amount of insulin needed to maintain healthy blood sugar levels ranging from 25 to 50 percent. The efficacy presents itself in a matter of a few days increasing steadily over two weeks to reach peak levels. It is believed that excess amounts of endogenous and exogenous insulin in the body down-regulate the insulin receptors - making them less sensitive to insulin. Insulin Sensitivity is now widely believed to be the major causal factor in Type 2 Diabetes.
In addition, INS2 may also reduce, or replace the amount of the sulfonylurea class of drugs widely used in treatment for Type 2 diabetes. These drugs enhance the beta cells in the pancreas to produce higher levels of insulin and thus lower blood glucose levels.
In the long run, however, these drugs cause the pancreatic beta cells to produce less insulin in what has been termed “beta cell burnout”. Aside from the hyperinsulinemia previously discussed in our section under Insulin Resistance, another downside is oftentimes referred to as “beta cell burnout” wherein the pancreas reduces or stops manufacturing insulin.
This demands that physicians prescribe insulin injections, the single-most dreaded event by patients here-to-fore using oral medications alone.
In addition, in recently released studies, these drugs have now been linked to cardiovascular events.
We believe that our investigational INS2 product will dramatically decrease the use of these drugs by improving cellular insulin receptor sensitivity. The only product with a similar action on the market today is GlaxoSmithKline’s Avandia®. This drug belongs to a class of drugs known as thiazolidinediones. Avandia appears to improve beta cell function. At this time we have not conducted such an analysis (beta cell function) of INS2, however, the improvement in insulin resistance achieved with INS2 increases the possibility that we will encounter similar results.
Most recently the FDA has issued additional labeling requirements for Avandia. In a recent article issued by the Cleveland Clinic, and reported in major medical journals, Avandia has proven to produce cardiovascular complications at an alarming rate. We are very confident that INS2 will be completely free of any and all complications.
The exact pharmacological action of the INS2 technology is unknown and under study at this time. A 100-patient double blind, placebo-controlled clinical trial, to be conducted at a major USA medical school, is scheduled to begin in 2009. We anticipate the clinical trial to be completed, the data analyzed, and the results submitted to FDA, as well as to the leading medical journals, by the end of 2009.
The protocol for the aforementioned clinical trial is being designed to measure the changes both in glycated hemoglobin, blood insulin levels, and insulin receptor function.
*Avandia® is a registered trademark belonging exclusively to GlaxoSmithKline.
