The CAVADEX® molecule
CAVADEX® is a form of Hydroxypropyl beta cyclodextrin (HPßCD) that is comprised of seven sugar molecules bound together in a ring (cyclic oligosaccharide).
The ring-shaped, three-dimensional structure has a hydrophobic cavity in its center, which is capable of trapping cholesterol and lipids. It has been used extensively as an excipient in the food, deodorant, and drug industry for the past century, and it is generally recognized as safe (GRAS).
As an active ingredient, CAVADEX® entraps and removes intracellular cholesterol and lipids that can cause injury to the kidneys and other organs, including the brain and liver.
Source: Lopez CA, de Vries AH, Marrink SJ (2011) Molecular Mechanism of Cyclodextrin Mediated Cholesterol Extraction. PLoS Comput Biol 7(3): e1002020. doi:10.1371/journal.pcbi.1002020.
Cholrem® has shown promising pre-clinical results in kidney disease. Progression of kidney disease was prevented in mouse models of focal segmental glomerulosclerosis (FSGS) and Alport Syndrome (AS), and diabetic kidney disease was prevented or partially prevented in two pre-clinical studies3.
Promising pre-clinical results have also been demonstrated in non-renal indications, including Alzheimer’s disease, atherosclerosis, non-alcoholic fatty liver disease, and Stargardt’s disease. A successful Phase 1 trial has been completed with HPßCD in patients with Niemann Pick, Type C1, an orphan condition associated with lipid accumulation in the brain and liver.
Cholrem® has successfully been administered to patients with advanced atherosclerosis and has shown to substantially reduce arterial plaque buildup in as little as 4 weeks of treatment.
Cholrem® is not orally bioavailable due to its high molecular weight and resistance to digestive enzymes, and therefore must be administered intravenously or as an enema. Once administered, Cholrem® is distributed to various tissues, with most accumulating in the kidney for excretion into the urine.
Our first patient results after 4 weeks of CAVADEX treatment
CAVADEX® melts away plaque
Our first patient had 12 intravenous CAVADEX® treatments over 4 weeks. The before and after angiogram images show CAVADEX® has removed a substantial amount of the patients plaque from his arteries allowing increased blood flow to the heart.
CAVADEX melts away plaque and cholesterol
plaque reduced in just 4 weeks
A recent study by the University Hospital in Bonn, Germany discovered that cyclodextrin melts away cholesterol crystals (the main cause of arterial plaque that clogs arteries) and reduced existing plaque within just 4 weeks. The cyclodextrin bound to and dissolved the cholesterol crystals from the plaque of mice, leading to transport of the dissolved cholesterol away from the plaques. The same effects were seen in human plaque samples treated with cyclodextrin.
Improve Liver function
Another study by the University of Texas Southwestern Medical Center, Dallas, Texas, shows the treatment of Npc1-deficient mice slows cholesterol sequestration in major organs and improves liver function. This study shows that cyclodextrin is effective in mobilizing entrapped cholesterol in late stage NPC disease leading to improved liver function.