(NASDAQ: CYTX) received US Patent No. 8,404,229 (the ‘229 patent) for methods of treating renal diseases using adipose-derived regenerative cells (ADRCs). The ‘229 patent covers treatment of a broad range of renal disorders, including acute kidney disease (AKD) and chronic kidney disease (CKD). The ‘229 patent also covers multiple means of delivering the ADRCs, including to the kidney directly, to the renal vasculature or to the renal parenchyma.
The ‘229 patent complements Cytori’s previously issued European Patent No. 1 778 834 (the ‘834 patent) directed to the treatment of renal disorders. Similar to the ‘229 US patent, the ‘834 European patent covers treatment of a broad range of renal disorders, including AKD and CKD. The ‘834 patent is effective in the United Kingdom, Germany, France, Netherlands, Spain, Belgium, Sweden, and select other European countries. Cytori now has 60 issued patents and more than 75 active patent applications worldwide.
“The renal patents are an important addition to our growing portfolio of ADRC patents,” said Chris Calhoun, Chief Executive Officer of Cytori. “CKD is an important co-morbidity of cardiovascular disease, Cytori’s core focus. Our platform technology and recent European approval of Intravase® for intravascular delivery allows us to explore related indications without compromising our focus on the core indications. Potentially, we would partner this indication to expedite bringing this therapy to market.”
Cytori’s renal patents reflect the Company’s previously
published preclinical data
showing that ADRCs improve renal function and reduce mortality in acute kidney injury (AKI). AKI represents a major clinical problem with high mortality and limited causal treatments. In the study, animals received either ADRCs or control after a renal injury was induced. Specific markers for kidney function and survival were assessed daily for seven days. Survival in the ADRC treated group was 100% and a statistically significant outcome compared to only 57% survival in the control group (p<0.005). Statistically significant functional and histologic improvements were also shown in serum creatinine (p<0.0001), blood urea nitrogen (p<0.0001) and renal cell necrosis (p<0.0001). This study provides substantial evidence of the potential of ADRC therapy for treating acute kidney injury.
Center for Disease Control
estimates that more than 10% of Americans, or 20 million people, suffer from chronic kidney disease (CKD). In addition, rates of acute kidney disease (AKD) are on the rise in the United States. According to a
University of California, San Francisco study
published in December 2012, on average, the incidence of AKD increased by 10% per year for the past decade. In 2010, the US renal market was estimated to be worth $21.7 billion, based a 2011 report from GBI Research.
About Adipose Tissue and ADRCs
Adipose tissue is the richest source of stem and regenerative cells in the body. This mixed population of cells, collectively referred to as ADRCs, is accessible at the point-of-care through the Celution® System for use in the same patient, creating new treatment opportunities for currently unmet medical needs. ADRCs collectively contribute to the healing process via cell-to-cell signaling, supporting improved blood flow and regulation of the inflammatory response.