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news.Spectrum Pharmaceuticals has begun Phase 2 study of SPI-2012 (long-acting GCSF drug candidate) to treat chemotherapy-induced neutropenia.
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The multicenter, open label trial will compare SPI-2012’s effectiveness relative to a fixed and standard dose of pegfilgrastim as a simultaneous active control to each dose of SPI-2012.
Evaluation of the effect of test doses 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, is the primary objective and endpoint of the study.
Spectrum Pharmaceuticals chairman, chief executive officer, and president Rajesh Shrotriya said chemotherapy-induced neutropenia constitutes a large global market estimated to be over $5bn.
"We look forward to the continued study of this product candidate, which we believe has the potential to address continued unmet medical needs by studying the opportunity to minimize the risks from chemotherapy induced neutropenia," Shrotriya added.
SPI-2012 established increase of neutrophil count similar to Neulasta (pegfilgrastim) at one-third the dose in the US-based Phase 1 trial.
SPI-2012 utilizes partner Hanmi Pharmaceutical Company’s proprietary Lapscovery technology.
The technology facilitates increased marrow penetration and G-CSF retention when compared to naked CSF and avoids elimination through kidney.