Spectrum Pharma Completes Enrollment In Phase 2 Study Of SPI-2012 - Quick Facts

(RTTNews) - Spectrum Pharmaceuticals (SPPI), a biotechnology company with fully integrated commercial and drug development operations and with a primary focus in Hematology and Oncology, said the key phase 2 trial of its long-acting granulocyte stimulating factor analog developed using LAPSCOVERY technology (SPI-2012) has completed its Phase 2 trial enrollment; this positions Spectrum for Phase 3 decision making before year end.

The company's Chief Executive stated, "SPI-2012 is the highest priority drug in our pipeline because of its unique technology, and its potential to provide a new, long-acting treatment option for patients with chemotherapy-induced neutropenia." He continued, "Pre-clinical and Phase 1 studies have demonstrated that SPI-2012 may have advantages regarding its potency and duration of neutrophil recovery compared to pegfilgrastim. After several years of early stage research, we are now getting closer to evaluating important mid-stage clinical results from SPI-2012. Based on these results, we look forward to making a Phase 3 Go/No-Go decision on SPI-2012 before the end of the year."

Spectrum's Phase 2 trial is a multicenter, dose-ranging study that assesses the effectiveness and safety of SPI-2012 relative to a fixed, standard dose of pegfilgrastim as a concurrent active control. The trial's primary endpoint is to evaluate the effect of SPI-2012 on the mean duration of severe neutropenia during Cycle 1 in breast cancer patients, who are candidates for adjuvant or neoadjuvant chemotherapy. Three doses of SPI-2012 were assessed compared with pegfilgrastim, the firm noted.