Spectrum Pharma Meets Primary Endpoint In Phase 2 Study Of Long Acting GCSF

(RTTNews) - Spectrum Pharmaceuticals Inc. (SPPI) said its phase 2 multi-center, dose-ranging study of Granulocyte Stimulating Factor or GCSF met primary end point and it is planning to start Phase 3 clinical trials next year.

The phase 2 study evaluated the effectiveness and safety of SPI-2012 with a standard dose of pegfilgrastim. The primary objective and endpoint of this study was to assess the effect of SPI-2012 on the mean duration of severe neutropenia during Cycle 1 in patients with breast cancer who received adjuvant or neoadjuvant chemotherapy. Three doses of SPI-2012 were evaluated compared to pegfilgrastim.

According to the company, the SPI-2012 was built upon the 3rd generation Lapscovery technology of Hanmi Pharm. Co. that differentiates from the existing drugs used to treat neutropenia, and it could potentially have advantages relating to more rapid and potent granulocyte or white blood cell recovery compared to pegylated filgrastim.

In January 2012, Spectrum entered into a co-development and commercialization agreement with Hanmi Pharm. Co., Korea, gaining rights for SPI-2012.