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 surpassing the primary endpoint in the pivotal, registrational Phase 2 BELIEF trial of belinostat, a pan-histone deacetylase (HDAC) inhibitor.
The BELIEF trial is evaluating the efficacy and safety of intravenous belinostat for the treatment of patients with relapsed/refractory peripheral T-cell lymphoma (PTCL). The BELIEF trial surpassed an objective response rate (ORR) of at least 20% in these patients, the study’s primary efficacy endpoint as established under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). The complete safety evaluation has been accepted for presentation at the T-Cell Lymphoma Forum to be held in San Francisco, Jan 24-26, 2013.
“Belinostat is an important compound in our late-stage development pipeline, and we are pleased to confirm the trial achieved its primary endpoint,” stated Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals, Inc. "We expect additional efficacy and safety findings will be presented at a major upcoming medical conference. Furthermore, based on our current timeline, we anticipate filing the NDA by the middle of next year, with a potential action date from the FDA in 2014.”
About Peripheral T-Cell LymphomaAccording to the Lymphoma Research Foundation ( www.lymphoma.org), lymphoma is the most common blood cancer. The two main forms of lymphoma are Hodgkin's lymphoma and non-Hodgkin's lymphoma (NHL). Lymphoma occurs when lymphocytes, a type of white blood cell, grow abnormally where they typically reside in the lymph glands. The body has two main types of lymphocytes that can develop into lymphomas: B-lymphocytes (B-cells) and T-lymphocytes (T-cells). Peripheral T-cell lymphoma (PTCL) comprises a group of rare and aggressive NHLs that develop from mature T-cells. PTCL accounts for approximately 10 to 15% of all NHL cases in the United States, and projections for annual cancer incidences point to 15,500 new cases of PTCL in the U.S. About Belinostat and the BELIEF Trial Belinostat is a Class I and II HDAC inhibitor being studied in multiple clinical trials as a single agent or in combination with chemotherapeutic agents for the treatment of various hematological and solid cancers. Its anticancer effect is thought to be mediated through multiple mechanisms of action, including the inhibition of cell proliferation, induction of apoptosis (programmed cell death), inhibition of angiogenesis, induction of differentiation, and the resensitization of cells that have become resistant to anticancer agents such as platinums, taxanes and topoisomerase II inhibitors. Belinostat is the only HDAC inhibitor in clinical development with multiple potential routes of administration, including short and continuous intravenous infusion; and oral administration.