Spectrum Pharmaceuticals, Inc. Announces Positive RenaZorb® Phase 1 Clinical Data Demonstrating Robust Activity in Easy-to-Swallow Pill Formulation
Published: Jan 07, 2013
HENDERSON, Nev.--(BUSINESS WIRE)--Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced positive, statistically significant data from the Company’s Phase 1 clinical trial evaluating the safety and tolerability of RenaZorb® (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.