Spectrum Pharmaceuticals Announces Achievement of Primary Endpoint in Belinostat Registrational Trial
<0> For Spectrum Pharmaceuticals, Inc.Shiv Kapoor, 702-835-6300Vice President, Strategic Planning & Investor Relations </0>
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.”
According to the Lymphoma Research Foundation (), 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.
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.
Conducted under a Special Protocol Assessment (SPA) agreement with the FDA, the pivotal, registrational Phase 2 BELIEF trial is evaluating intravenous belinostat as monotherapy for relapsed or refractory peripheral T-cell lymphoma (PTCL), an indication for which this drug candidate has been granted Orphan Drug and Fast Track designations by the FDA. The BELIEF trial is an open-label, international, single arm efficacy and safety study in patients with relapsed or refractory PTCL, who have failed at least one prior systemic therapy. The primary endpoint of the trial is centrally reviewed objective response rate (ORR). The trial included approximately 100 clinical centers globally, with completion of patient enrollment announced in September 2011.
Spectrum Pharmaceuticals is a leading biotechnology company focused on acquiring, developing, and commercializing drug products, with a primary focus in oncology and hematology. Spectrum and its affiliates market three oncology drugs ─ FUSILEV (levoleucovorin) for Injection in the U.S.; FOLOTYN (pralatrexate injection), also marketed in the U.S.; and ZEVALIN (ibritumomab tiuxetan) Injection for intravenous use, for which the Company has worldwide marketing rights. Spectrum's strong track record in in-licensing and acquiring differentiated drugs, and expertise in clinical development have generated a robust, diversified, and growing pipeline of product candidates in advanced-stage Phase 2 and Phase 3 studies. More information on Spectrum is available at .