Spectrum Pharmaceuticals has commenced Phase II study of long-acting GCSF drug candidate, SPI-2012, to treat chemotherapy-induced neutropenia.
SPI-2012 utilises partner Hanmi Pharmaceutical’s proprietary Lapscovery technology, which facilitates greater marrow penetration and retention of G-CSF when compared to naked CSF, and avoids elimination through the kidneys.
Spectrum Pharmaceuticals chairman, chief executive officer and president Dr 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 said.
SPI-2012 established increase of neutrophil count similar to Neulasta (pegfilgrastim) at one-third the dose in the US-based Phase I trial.
The multicentre, open label, Phase II trial is designed to 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.
The primary objective and endpoint of the study is 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.
In January 2012, Spectrum and Hanmi signed a co-development and commercialisation agreement for global rights to SPI-2012, except in Korea, China and Japan where Spectrum holds the rights.