Spectrum Pharma's Trial Of Captisol-Enabled Melphalan Meets Primary Endpoint

(RTTNews) - Ligand Pharmaceuticals Inc. (LGND) said its Captisol-enabled Melphalan or CE Melphalan development and commercial partner Spectrum Pharmaceuticals (SPPI) has reported that their pivotal study of CE Melphalan achieved its primary endpoint.

According to Spectrum Pharmaceuticals, CE Melphalan is being developed as a novel version of the well-established conditioning treatment in autologous transplant for patients with multiple myeloma. CE Melphalan does not include propylene glycol, an ingredient of currently available products which has been associated with renal and cardiac side effects.

According to the company, the improved stability profile of CE Melphalan could result in rapid adoption in the transplant conditioning market. Spectrum Pharmaceuticals plans to file a New Drug Application or NDA with the U.S. Food and Drug Administration or FDA in the third quarter 2014, and intends to launch this drug with its existing hematology/oncology sales force next year pending approval.

Spectrum Pharmaceuticals noted that the Phase 2 pivotal trial was a multicenter study assessing safety and efficacy. The study's primary goal 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. The secondary objectives evaluated the efficacy of CE Melphalan in this patient population as measured by multiple myeloma response rate, and the rates of myeloablation and engraftment.