Target enrollment reached in belinostat Phase 2 study in Carcinoma of Unknown Primary

Spectrum PharmaceuticalsDec 23 2010

Spectrum Pharmaceuticals (NasdaqGM: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, announced today that the target enrollment has been reached for the Phase 2 study of belinostat in Carcinoma of Unknown Primary (CUP). The study, which is being conducted and fully funded by Spectrum's partner, Topotarget A/S, is an open-label, randomized, controlled Phase 2 study in which patients with previously untreated CUP, were randomized into one of two treatment arms: Belinostat + carboplatin and paclitaxel (BelCaP), or carboplatin and paclitaxel (CaP). The primary objective of the CUP study is to provide an estimate of the treatment effect of BelCaP compared to CaP in terms of progression-free survival, response rate, and overall survival in patients with CUP.

"We believe that belinostat is an HDAC inhibitor with the potential safety advantage that allows for full-dose combination with other chemotherapeutic regimens, including carboplatin and paclitaxel, which are considered mainstays of cancer treatment," said Rajesh C. Shrotriya, MD, Chairman of the Board of Directors, Chief Executive Officer, and President of Spectrum Pharmaceuticals. "We look forward to the results of this trial, which Topotarget believes will be available in the third quarter of 2011."

Topotarget expects top-line results of progression-free survival and response rate in the third quarter of 2011. Final evaluation of overall survival is expected in the first quarter of 2012. The data from this randomized, controlled proof-of-concept study will help delineate the role of belinostat in combination with chemotherapy in the treatment of patients with CUP.