HENDERSON, Nev.--()--Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology and hematology, today announced the initiation of patient enrollment in a Phase 1 clinical trial evaluating the safety and tolerability of RenaZorb® (also referred to as SPI-014) in healthy volunteers. RenaZorb is a lanthanum-based nanotechnology compound with potent phosphate-binding properties.
“We are excited to announce the first human clinical study of RenaZorb, which we have initiated based on the promising research findings we have seen”
“We are excited to announce the first human clinical study of RenaZorb, which we have initiated based on the promising research findings we have seen,” stated Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals, Inc. “Over 90% of patients with kidney failure use oral phosphate binders to prevent hyperphosphatemia, yet there is often poor compliance due to gastrointestinal (GI) intolerance and excessive pill burden associated with current therapies. Further, in vitro research has shown that RenaZorb has much higher phosphate-binding capacity than current products on the market. We believe this will allow us to provide the same amount of phosphate-binding capacity at a lower dose and smaller tablet size, thus improving patient compliance. Based on these and other product characteristics, we feel RenaZorb has the potential to offer increased patient benefit and look forward to the swift completion of Phase 1 testing and further progress of the program.”
The double-blind, dose-ranging, Phase 1 study in healthy volunteers is designed to evaluate the safety and the phosphate-binding capacity of RenaZorb. The primary endpoint is capacity to bind phosphorous ingested with food, evaluated by comparing the difference in urine and fecal phosphorus levels measured before and after RenaZorb dosing. Secondary endpoints are safety and tolerability along with measurements of serum lanthanum levels. The study is expected to enroll 32 healthy volunteers into four sequential dose cohorts of eight subjects each. Six subjects will be randomly assigned to receive RenaZorb and two subjects to receive placebo within each cohort. RenaZorb will be taken orally three times a day within 15 minutes after meals in all four cohorts (1500 mg/day, 3000 mg/day, 4500 mg/day and 6000 mg/day). Renal excretion of phosphate is expected to decrease and fecal excretion of phosphate is expected to increase after RenaZorb dosing.
RenaZorb, or SPI-014, is formulated as an orally available tablet of lanthanum-based nanotechnology with highly potent phosphate-binding properties for the potential treatment 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 and cardiovascular disease, and is independently associated with increased mortality. Currently marketed therapies for treating hyperphosphatemia account for sales estimated at $1 billion worldwide and include binders that are polymer-based, lanthanum-based, and aluminum/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. In 2009, there were an estimated 571,414 patients with ESRD.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals, a biotechnology company with a primary focus in oncology and hematology, currently markets two oncology drugs, FUSILEV® (levoleucovorin) for Injection and ZEVALIN® (ibritumomab tiuxetan) Injection for intravenous use. In addition, Spectrum has two drugs, belinostat and apaziquone, in late-stage development and a diversified pipeline of novel drug candidates in earlier stages of development. The Company's strategy is comprised of acquiring, developing and commercializing a broad and diverse pipeline of late-stage clinical and commercial drug products. The Company has aggressive business development and commercial operation teams that support a robust drug development program encompassing clinical development, medical research, regulatory affairs, biostatistics and data management. 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.
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®, FUSILEV®, and RenaZorb® are registered trademarks of Spectrum Pharmaceuticals, Inc. REDEFINING CANCER CARE™ and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc.
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