CURRENT THERAPIES: MANAGING PERSISTENT DETERIORATION OF KIDNEY DISEASE WITHOUT HOPE
Current CKD treatment options are limited to supportive care with medications. The most commonly prescribed medications to treat CKD patients include Vitamin D, blood pressure, phosphorus-lowering, and anti-anemia medications. When patients descend into ESRD, dialysis or kidney transplantation become the only available treatment options. For nearly 65% of dialysis patients, life expectancy is estimated at no longer than 5 years. While kidney transplantation provides better outcomes, it is severely limited not only by the shortage of organs, but also by very high morbidity and complications in the first six months post transplantation.
The magnitude of CKD prevalence and the costs of ESRD treatment demand an innovative response. KidneyCure is developing novel approach to delay the deterioration of CKD towards ESRD by integrating revitalized renal epithelial cells into the patient’s kidney to improve its function.
3DAN™ – THREE DIMENSIONAL ADULT NEPHROFORMS APPROACH
The company’s lead product, 3DAN™-001, is based on autologous, three-dimensional renal epithelial adult cell-forms suspended in a proprietary formulation adapted for delivery into the kidney. The breakthrough research, which served as the scientific basis for KidneyCure’s innovative therapy, has been conducted by Prof. Dekel at the Sheba Medical Centre in Israel, rated recently as one of the ten best hospitals in the world by the Newsweek magazine.
KidneyCure is also working on developing its second product – 3DAN™-002, based on urine-derived renal cells. 3DAN™-002 will allow collecting renal cells from the urine of CKD patients in vast quantity while obviating the need for biopsy.
3DAN™: STRONG INTELLECTUAL PROPERTY AND EXPEDIENT REGULATORY PLAN
Given the tremendous unmet medical need, lack of optimal therapies and rapidly growing number of CKD patients, KidneyCure is evaluating the opportunity for obtaining conditional regulatory approval. Under a conditional approval pathway, promising therapies can be authorized following phase II trials, provided they demonstrate safety and probable efficacy results. This novel regulatory approach could facilitate earlier patient access to life-saving therapies and accelerated market entry.
The Company has developed a robust IP estate comprising three families of patents associated with (i) the 3DAN-001 lead product, (ii) products relating to genetically reprogrammed kidney cells and (iii) products relating to fetal renal cells.