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Home > Press > Spectrum Pharmaceuticals Files IND Application with U.S. FDA for SPI-014

Abstract:
- SPI-014, a Novel Lanthanum-Based Compound, is Being Developed as a Treatment for the Increased Blood Levels of Phosphorus Seen in End Stage Renal Disease

- Based on Proprietary Nanoparticle Technology, Spectrum's Small, Easy-to-Swallow Tablets Are Designed to Improve Phosphate Binding; SPI-014 Has the Potential to Meaningfully Improve Patients' Lives

- Phase I Study Expected to Be Initiated Soon after FDA Review

Spectrum Pharmaceuticals Files IND Application with U.S. FDA for SPI-014

Henderson, NV | Posted on December 6th, 2011

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.

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."

####

About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals is a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology. The Company’s strategy is to acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products. The Company markets two oncology drugs, FUSILEV and ZEVALIN, and has two drugs, apaziquone and belinostat, in late stage development along with a diversified pipeline of novel drug candidates. The Company has assembled an integrated in-house scientific team, including clinical development, medical research, regulatory affairs, biostatistics and data management, formulation development, and has established a commercial infrastructure for the marketing of its products. The Company also leverages the expertise of its worldwide partners to assist in the execution of its strategy. For more information, please visit the Company’s website at www.sppirx.com.

About SPI-014

SPI-014 is a non-aluminum, non-polymer, non-calcium, lanthanum-based nanoparticle with highly potent and selective phosphate binding properties, for the potential treatment via oral administration, of hyperphosphatemia (high phosphate levels in the blood), in patients with chronic kidney disease (CKD). Hyperphosphatemia in Stage 5 CKD, also known as end-stage renal disease (ESRD), can lead to significant bone disease (including pain and fractures), secondary hyperparathyroidism, cardiovascular disease, and is independently associated with increased mortality. Currently marketed therapies for treating hyperphosphatemia include polymer-based and lanthanum-based phosphate binders, aluminum-based phosphate binders, and calcium-based phosphate binders. According to the United States Renal Data System (USRDS), over the last 20 years, the number of patients with ESRD in the US has grown 4-fold.

Forward-looking statement – This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements are based on management’s current beliefs and expectations. These statements include but are not limited to statements that relate to our business and its future, including certain company milestones, Spectrum's ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, leveraging the expertise of partners and employees, around the world to assist us in the execution of our strategy, and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates may not prove safe or effective, the possibility that our existing and new applications to the FDA may not receive approval, and other regulatory agencies in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of sustained revenue history, our limited marketing experience, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company's reports filed with the Securities and Exchange Commission. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.

SPECTRUM PHARMACEUTICALS, INC.®, ZEVALIN®, and FUSILEV® are registered trademarks of Spectrum Pharmaceuticals, Inc. REDEFINING CANCER CARE™ and the Spectrum Pharmaceuticals logos are trademarks owned by Spectrum Pharmaceuticals, Inc.

For more information, please click here

Contacts:
Spectrum Pharmaceuticals, Inc.
Paul Arndt
Senior Manager
Investor Relations
702-835-6300

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