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news.Spectrum Pharmaceuticals has announced that the key Phase II trial of its long-acting granulocyte stimulating factor analog developed using LAPSCOVERY technology (SPI-2012) has completed its Phase II study enrollment; this positions Spectrum for Phase III decision making before year end.
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Spectrum Pharmaceuticals chairman and CEO Rajesh Shrotriya said that SPI-2012 is the highest priority drug in the company’s pipeline because of its unique technology, and its potential to provide a new, long-acting treatment option for patients with chemotherapy-induced neutropenia.
"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," Shrotriya added.
Spectrum’s Phase II trial is a multicenter, dose-ranging study that evaluates the effectiveness and safety of SPI-2012 relative to a fixed, standard dose of pegfilgrastim as a concurrent active control.
The primary objective and endpoint of this study is to assess the effect of SPI-2012 on the mean duration of severe neutropenia during Cycle 1 in patients with breast cancer who are candidates for adjuvant or neoadjuvant chemotherapy. Three doses of SPI-2012 were evaluated compared to pegfilgrastim.
In January 2012, Spectrum entered into a co-development and commercialization agreement with Hanmi, gaining global rights for SPI-2012 except Korea, China, and Japan.