Spectrum Pharmaceuticals Announces Presentation of Belinostat Safety Profile from BELIEF Registrational Phase 2 Trial …

HENDERSON, Nev.--(BUSINESS WIRE)--

Spectrum Pharmaceuticals (SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced safety findings from the pivotal, registrational Phase 2 BELIEF trial of belinostat, a pan-histone deacetylase (HDAC) inhibitor. As featured in an oral presentation at the T-Cell Lymphoma Forum held in San Francisco, January 24-26, the BELIEF trial safety evaluation showed belinostat had an acceptable safety profile in patients with relapsed/refractory peripheral T-cell lymphoma (R/R PTCL), including patients who have received a previous allogeneic or autologous stem cell transplant.

The BELIEF trial is evaluating the efficacy and safety of intravenous belinostat for the treatment of patients with R/R PTCL. As announced in December 2012, the BELIEF trial surpassed an objective response rate (ORR) of at least 20% in these patients, the studys primary efficacy endpoint as established under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA).

We are pleased that the T-Cell Lymphoma Forum, one of the preeminent conferences for innovation in the treatment of blood cancers, highlighted the BELIEF study comprehensive safety profile, stated Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals, Inc. Belinostat showed acceptable safety findings in the BELIEF trial which was designed to enroll relapsed or refractory PTCL patients; including those who received a previous stem cell transplant; with a platelet count greater than or equal to 50,000. Many of these refractory patients with low platelet counts were not eligible for treatment on trials with alternative agents. The BELIEF safety profile, as well as ongoing studies of belinostat in combination with cytotoxic regimens, may provide support to seek approval for indications in both monotherapy and combination therapy with belinostat for patients with PTCL. We look forward to progress of the program, including an anticipated NDA filing by mid-2013.

About Peripheral T-Cell Lymphoma

According 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.

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.

About Spectrum Pharmaceuticals, Inc.

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Spectrum Pharmaceuticals Announces Presentation of Belinostat Safety Profile from BELIEF Registrational Phase 2 Trial ...