Spectrum Pharmaceuticals, Inc. announced positive, statistically significant data from the Company's Phase 1 clinical trial evaluating the safety and tolerability of RenaZorb(R) (also referred to as SPI-014) in healthy volunteers. RenaZorb is an orally available, lanthanum-based nanotechnology compound with potent phosphate-binding properties that is being developed for the potential treatment of hyperphosphatemia (high phosphate levels in the blood) in patients with stage 5 chronic kidney disease (CKD). The Phase 1 clinical findings showed that (1) RenaZorb is well-tolerated up to the maximum administered dose of 6000 mg/day, showing no serious adverse events, low systemic exposure, and no discontinuations of therapy, (2) RenaZorb resulted in statistically significant reductions in daily urinary phosphorous excretions at all four dose levels (1500 mg/day, 3000 mg/day, 4500 mg/day and 6000 mg/day) compared to placebo.

The double-blind, dose-ranging, Phase 1 study in healthy volunteers was designed to evaluate the safety, PK and the phosphate-binding capacity of RenaZorb. The primary endpoint is safety and tolerability. Secondary endpoints are pharmacokinetics (measurements of serum lanthanum levels) and phosphate binding capacity (capacity to bind phosphorous ingested with food, evaluated by comparing the difference in urine and fecal phosphorus levels measured before and after RenaZorb dosing).

The study enrolled 32 healthy volunteers into four sequential dose cohorts of eight subjects each. Six subjects were randomly assigned to receive RenaZorb and two subjects to receive placebo within each cohort. RenaZorb was 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).

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.