Spectrum Pharmaceuticals, a biotechnology company focused in hematology and oncology, announced that it has submitted an investigational new drug (IND) application called SPI-014 to the U.S. Food & Drug Administration.
Previously referred to as RENAZORB, SPI-014 is a second-generation lanthanum-based nanoparticle phosphate binding agent. In a press release, Spectrum Pharmaceuticals claimed that SPI-014 has the potential to treat hyperphosphatemia in patients with Stage 5 chronic kidney disease, or end-stage renal disease (ESRD).
Hyperphosphatemia (high phosphate levels in blood) negatively affects patients with chronic kidney disease, especially end-stage kidney disease patients on dialysis. It can lead to significant bone disease (including pain and fractures) and cardiovascular disease, and is independently associated with increased mortality. According to the United States Renal Data System, there were more than 571 thousand patients with ESRD in the United States in 2009.
Currently polymer-based and lanthanum-based phosphate binders, aluminum-based phosphate binders, and calcium-based phosphate binders are used as therapies for treating hyperphosphatemia. These therapies require the ingestion of a large number of pills, or large size pills that need to be chewed or swallowed along with each meal, leading to problems with patient compliance with the treatment regimen. MD, Chairman and Chief Executive Officer, and President of Spectrum Pharmaceuticals Rajesh C. Shrotriya claimed that SPI-014 has the potential to reduce the pill dosage burden and enable more effective management for ESRD patients.
According to the company, SPI-014 is a non-aluminum, non-polymer, non-calcium, lanthanum-based nanoparticle with highly potent and selective phosphate binding properties. The medicine can support the treatment via oral administration, of hyperphosphatemia (high phosphate levels in the blood), in patients with chronic kidney disease (CKD). Spectrum Pharmaceuticals has the worldwide rights and intellectual property to develop SPI-014 for all human and non-human therapeutic uses.
“After several years of preclinical research and a thoughtful analysis of the market opportunity, we have decided to advance SPI-014 into clinical studies. Because of its potentially higher capacity for binding phosphate on an equal weight basis, SPI-014 is a drug candidate with the potential to reduce the pill dosage burden and enable more effective management for ESRD patients. We will continue to opportunistically advance therapies that have the potential to meaningfully impact patients' lives. We expect to commence Phase I studies as soon as possible after FDA review,” Chairman and Chief Executive Officer and President of Spectrum Pharmaceuticals Rajesh C. Shrotriya noted in a statement.
A couple of months back, Spectrum reported record financial results for the three- and nine-month periods ended September 30, 2011.
Madhubanti Rudra is a contributing editor for HealthTechZone. To read more of her articles, please visit her columnist page.Edited by
Rich Steeves
