US-based Spectrum Pharmaceuticals has started a Phase III trial (ADVANCE) of its granulocyte colony-stimulating factor (G-CSF), SPI-2012 (eflapegrastim), to treat patients with breast cancer.
The trial is designed to evaluate SPI-2012 as a treatment for chemotherapy-induced neutropenia, and will serve as the basis for the filing of a biologics license application (BLA).
SPI-2012 uses a proprietary technology to maximise the pharmacological activity of G-CSF, resulting in increased potency and a prolonged half-life.
Around 580 patients with breast cancer will be enroled in the trial, which is being conducted under a special protocol assessment (SPA) agreement with the US Food and Drug Administration (FDA).
The company expects around 100 investigators in the US and Canada to participate in the trial, and intends to complete enrolment in 2017.
Spectrum Pharmaceuticals chairman and chief executive officer Rajesh Shrotriya said: "The initiation of the registration trial for SPI-2012 is a significant milestone in the history of our company.
"Revenues from our current marketed drugs have helped us invest in this technology that opens the door for us to a blockbuster oncology market.
"In parallel, Spectrum has built a strong commercial infrastructure with specialised expertise in this indication that positions us well to aggressively compete in this market."
In the trial, early-stage breast cancer patients will receive adjuvant or neoadjuvant chemotherapy every 21 days.
SPI-2012 will be administered subcutaneously as a fixed dose equivalent to 3.6mg of GCSF, which was selected based on the robust pharmacological and pharmacodynamic data from Phase II.
Community Oncology Alliance vice-president and North Shore Hematology / Oncology Associates Clinical Research managing partner and chief Jeffrey Vacirca said: "SPI-2012 is a third generation agent for the treatment of neutropenia that has shown promising results in Phase II trials.
"In the Phase II trial, the duration of severe neutropenia was equivalent to pegfilgrastim at the medium dose and superior at the high dose.
"No new or significant dose-related toxicities have been observed in over 230 patients who have been treated with SPI-2012, and the incidence of adverse events has been similar to pegfilgrastim."