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.
"The first clinical data for RenaZorb show effective phosphate lowering in a convenient, easy-to-swallow pill formulation, which we believe can address substantially the poor compliance associated with current therapies,” stated Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals, Inc. “Because of the higher phosphate-binding capacity of RenaZorb compared to current products, as shown in in vitro studies, we believe this allows us to offer lower dosing and a smaller, patient-friendly tablet size. Based on the current progress of our clinical program, we are planning for Phase 2 testing and also are seeking a licensing partner outside of the U.S., in particular, in Japan and other countries in Asia.”
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).