Top-line data from Spectrum's SPI-1620 Phase 1 combination study on carcinoma

Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced that top-line data from part one of a two-part Phase 1 study of SPI-1620 in combination with docetaxel was presented in an oral presentation at the 12^th International Conference on Endothelin, held in Cambridge, United Kingdom, from September 11-14, 2011. Part one of the study has been completed, while part two is ongoing.

The primary objective of this Phase 1 study was to assess the safety and tolerability of SPI-1620 administered to patients with recurrent or progressive carcinoma who have failed all standard therapy. Secondary objectives of the study include assessing the pharmacokinetic and pharmacodynamic profiles of SPI-1620 and identifying the optimum dose of SPI-1620 to be used in future Phase 2 studies.

A total of 30 patients were enrolled in this study. Patients ranged in age from 41 to 77 years (median 61), and had prostate cancer (9/30), breast cancer (3/30), female reproductive malignancies (4/30), gastrointestinal cancer (3/30), and pancreatic cancer (2/30), among other types.

Anthony W. Tolcher, M.D., FRCP, Director of Clinical Research at South Texas Accelerated Research Therapy, and the principal investigator of the Phase 1 study, said, "SPI-1620, a novel anti-tumor endothelin-B agonist agent, when combined with docetaxel, has had impressive responses in difficult to treat carcinomas. These preliminary observations deserve confirmation in a Phase 2 study, which is under development. In addition, lung cavitation suggesting necrosis at previous tumor sites was noted in responding patients."

Among the 30 patients, all of whom were treated with SPI-1620 and docetaxel, 5 partial responses (PR) were seen. Of the 5 partial responses, two were in prostate cancer, and those patients experienced a prolonged duration of response of approximately 12 and 18 months. Encouraging antitumor activity was also seen in patients with cholangiocarcinoma, transitional cell urothelial carcinoma, and ovarian cancer.

"We are very pleased with the promising top-line data from the SPI-1620 study and believe that it could be an effective drug in the treatment of solid tumors," said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. "Spectrum is committed to bringing safe and effective treatment options to cancer patients. We look forward to continuing the development of SPI-1620, and we currently expect to initiate a Phase 2 study for SPI-1620 in 2012."