Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology and hematology, has begun 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," 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 programme."

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.