Spectrum seeks FDA IND approval for SPI-014 to treat hyperphosphatemia

Spectrum Pharmaceuticals (NasdaqGS: SPPI) today announced that it has submitted an investigational new drug (IND) application to the U.S. Food & Drug Administration for SPI-014 (previously referred to as RENAZORB®), a second-generation lanthanum-based nanoparticle phosphate binding agent, that has the potential to treat hyperphosphatemia in patients with Stage 5 chronic kidney disease, or end-stage renal disease (ESRD). 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”

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 marketed therapies for treating hyperphosphatemia include polymer-based and lanthanum-based phosphate binders, aluminum-based phosphate binders, and calcium-based phosphate binders. Under the National Kidney Foundation K/DOQI guidelines, both calcium-based phosphate binders and non-calcium, non-aluminum, non-magnesium phosphate binders are recommended as first line or long-term therapy for the management of hyperphosphatemia. However, current 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.

"After several years of preclinical research and a thoughtful analysis of the market opportunity, we have decided to advance SPI-014 into clinical studies," said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. "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."


 Spectrum Pharmaceuticals, Inc.


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