Spectrum Pharmaceuticals (SPPI) announced encouraging results from a phase II pivotal study on captisol-enabled melphalan. The candidate is being developed as an intravenous formulation of melphalan (a well-known conditioning therapy). Spectrum Pharma gained over 4% following the announcement.
The candidate met the primary objective of the study of an overall safety and toxicity profile before autologous stem cell transplantation (:ASCT) in patients suffering from multiple myeloma. The study also evaluated the efficacy of captisol-enabled melphalan in these patients as measured by the multiple myeloma response rate (as per International Myeloma Working Group criteria) and the rates of myeloablation and engraftment.
Spectrum Pharma is conducting additional analyses on the candidate. The company intends to file a New Drug Application (:NDA) for captisol-enabled melphalan in the U.S. in the third quarter of this year.
In Mar 2013, Spectrum Pharma acquired the development and commercialization rights to captisol-enabled melphalan from Ligand Pharmaceuticals Inc. (LGND). Ligand Pharma will receive license fees, milestone payments and royalties from Spectrum Pharma following potential commercialization of the candidate.
Spectrum Pharma has Beleodaq (relapsed or refractory peripheral T-cell lymphoma) under review in the U.S. A final decision from the FDA on the approval of Beleodaq is expected by Aug 9, 2014. The successful development and commercialization of both the candidates will be beneficial for Spectrum Pharma.
Spectrum Pharma currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks include ImmunoGen, Inc. (IMGN) and Biogen Idec Inc. (BIIB). While ImmunoGen carries a Zacks Rank #1 (Strong Buy), Biogen holds a Zacks Rank #2 (Buy).