Date: 2014-09-09
Type of information: Initiation of development program
phase: 3
Announcement: initiation of the development program
Company: Spectrum Pharmaceuticals (USA - NV)
Product: SPI-2012
Action
mechanism: SPI-2012 is a long-acting G-CSF that utilizes a proprietary platform technology of Hanmi Pharm. Co., LAPSCOVERY™, designed to maximize pharmacological activity of G-CSF.
Disease: neutropenia
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On September 9, 2014, Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology andoncology, announced the Phase 3 Go/No-Go decision for SPI-2012, its long acting Granulocyte Stimulating Factor (G-CSF), and is planning for the start of Phase 3 clinical trials next year.
Spectrum will use the learnings from its Phase 2 enrollment to accelerate Phase 3 enrollment. This Phase 2 trial was a multicenter, dose-ranging study that evaluated 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 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. The company plans to present results for presentation at a premier scientific conference in the first half of 2015. In January 2012, Spectrum entered into a co-development and commercialization agreement with Hanmi Pharm. Co., Korea, gaining rights for SPI-2012.
Spectrum Pharmaceuticals and its affiliates market five oncology drugs? FUSILEV® (levoleucovorin) for Injection in the U.S.; FOLOTYN® (pralatrexate injection), also marketed in the U.S.; ZEVALIN® (ibritumomab tiuxetan) Injection for intravenous use, for which the Company has worldwide marketing rights; MARQIBO® (vinCRIStine sulfate LIPOSOME injection) for intravenous infusion, for which the Company has worldwide marketing rights and BELEODAQ™(belinostat) for Injection in the U.S. Spectrum\'s strong track record in in-licensing and acquiring differentiated drugs, and expertise in clinical development have generated a robust, diversified, and growing pipeline of product candidates in advanced-stage Phase 2 and Phase 3 studies.
