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 its pivotal trial of Captisol-enabled™ (propylene glycol-free) Melphalan met its primary end points.
"I am pleased with the focus and alacrity in which our clinical team has executed this trial," said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. "With the positive results from this trial, we are one step closer to providing patients and healthcare providers with a much needed new formulation of Melphalan. Melphalan is currently a well-established conditioning treatment in autologous transplant for patients with multiple myeloma. Our novel Captisol-enabled Melphalan is free of propylene glycol, which itself is associated with renal and cardiac side effects. Additionally, the improved stability profile of CE Melphalan could be valuable in its rapid adoption in the transplant conditioning market. This product also fits seamlessly into our existing commercial and research infrastructure. With key upcoming catalysts related to CE Melphalan, Beleodaq and SPI-2012, we continue to be committed to building a world-class Hematology/Oncology company."
The phase 2 pivotal trial evaluating CE Melphalan was a multi-center trial evaluating safety and efficacy. The primary objective of the study was to determine the overall safety and toxicity profile in multiple myeloma patients receiving 200 mg/m2 of CE Melphalan as myeloablative therapy prior to autologous stem cell transplantation (ASCT). The secondary objectives evaluated the efficacy of CE Melphalan in this patient population as measured by multiple myeloma response rate (according to International Myeloma Working Group [IMWG] criteria), and the rates of myeloablation, and engraftment. The primary endpoint of this Phase 2 trial was met, and additional analyses are currently underway. The company plans to file an NDA in the third quarter.
In a previous clinical study, Captisol-enabled Melphalan met the requirements for establishment of bioequivalence to the current commercial intravenous formulation of melphalan.
Spectrum Pharmaceuticals gained global development and commercialization rights to CE Melphalan from Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) in March 2013. Spectrum assumed the responsibility for the pivotal clinical trial and is responsible for filing an NDA. Under the license agreement, Ligand received a license fee and is eligible to receive milestone payments, as well as royalties following potential commercialization.
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