HENDERSON, Nev.--(BUSINESS WIRE)--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 that it has achieved the target enrollment of the minimum of 100 evaluable relapsed or refractory peripheral T-cell lymphoma (PTCL) patients in the BELIEF registration trial. Belinostat, a novel HDAC inhibitor, is being evaluated, under a Special Protocol Assessment (SPA), as monotherapy treatment for relapsed or refractory PTCL, an indication for which it has been granted Orphan Drug and Fast Track designation by the U.S. Food and Drug Administration (FDA). Central review of pathology for all patients entered onto the trial is currently ongoing.
“We are pleased to announce that belinostat’s pivotal, registrational trial in relapsed/refractory PTCL has achieved its target enrollment,” said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. “Belinostat is a novel HDAC inhibitor that has the potential to play an important role in therapy for PTCL, an often lethal disease with significant unmet medical need, and in a variety of other indications. It has shown to be active as a single agent and in combination with other chemotherapeutic agents in multiple clinical trials. We plan to file a New Drug Application in 2012. If approved, we believe belinostat will add value to our existing hematology/oncology portfolio, increase our current sales efforts in hematology/oncology, and demonstrate our commitment to developing novel treatments for 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 (HL) and non-Hodgkin’s lymphoma (NHL). Lymphoma occurs when lymphocytes, a type of white blood cell, grow abnormally where they 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). 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.
About the BELIEF Registrational Study
Belinostat is currently in a registrational, pivotal trial, under an SPA, as monotherapy for relapsed and refractory PTCL, an indication which has been granted Orphan Drug and Fast Track designation by the FDA. The registrational trial is an open-label, multicenter, 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 is centrally reviewed objective overall response rate (ORR).
About Belinostat
Belinostat (PXD 101) is a Class I and II HDAC inhibitor that is 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 intravenous administration, continuous intravenous infusion and oral administration.
Belinostat is currently in a registrational trial, the BELIEF Study, under a SPA, as monotherapy for relapsed or refractory PTCL, an indication for which it has been granted Orphan Drug and Fast Track designations by the FDA. Belinostat is also under investigation in a randomized Phase 2 trial, as a combination therapy with carboplatin and paclitaxel, for cancer of unknown primary (CUP). The CUP study is being run and fully funded by our partner Topotarget A/S. Additionally, the National Cancer Institute is currently conducting several clinical trials of belinostat in a variety of hematological and solid tumors, both as monotherapy as well as combination therapy.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology. The Company’s strategy is comprised of acquiring, developing and commercializing a broad and diverse pipeline of late-stage clinical and commercial products. The Company markets two oncology and hematology drugs, FUSILEV and ZEVALIN and has two drugs, apaziquone and belinostat, in late stage development along with a diversified pipeline of novel drug candidates. The Company has assembled an integrated in-house scientific team, including clinical development, medical research, regulatory affairs, biostatistics and data management, formulation development, and has established a commercial infrastructure for the marketing of its drug products. The Company also leverages the expertise of its worldwide partners to assist in the execution of its strategy. For more information, please visit the Company’s website at www.sppirx.com.
Forward-looking statement – This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements are based on management’s current beliefs and expectations. These statements include but are not limited to statements that relate to our business and its future, including certain company milestones, Spectrum's ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, leveraging the expertise of partners and employees, around the world to assist us in the execution of our strategy, and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates, may not prove safe or effective, the possibility that our existing and new drug candidates may not receive approval from the FDA, and other regulatory agencies in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of sustained revenue history, our limited marketing experience, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company's reports filed with the Securities and Exchange Commission. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.
SPECTRUM PHARMACEUTICALS, INC. ®, ZEVALIN®, and FUSILEV® are registered trademarks of Spectrum Pharmaceuticals, Inc. REDEFINING CANCER CARE™ and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc.
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