Spectrum Submits IND Application for SPI-014

The company expects to commence Phase I studies of the drug candidate used for ESRD patients as soon as possible after FDA review.

Spectrum Pharmaceuticals, a biotechnology company with a focus in oncology, announced Monday that it has submitted an investigational new drug (IND) application to the U.S. FDA for SPI-014, a second-generation lanthanum-based nanoparticle phosphate binding agent.

SPI-014 has the potential to treat hyperphosphatemia in patients with Stage 5 chronic kidney disease, or end-stage renal disease (ESRD).

Spectrum has the worldwide rights and intellectual property to develop SPI-014 for all human and non-human therapeutic uses.

"After several years of preclinical research and a thoughtful analysis of the market opportunity, we have decided to advance SPI-014 into clinic