Good news:
Independent Data Monitoring Committee Recommends Continuation of Spectrum Pharmaceuticals’ Pivotal Registrational Study of Belinostat in Peripheral T-Cell Lymphoma
Independent Data Monitoring Committee (DMC) Recommends That the BELIEF Study Continue According to Protocol Until 100 Evaluable Patients Enrolled
No Safety Concerns Raised Based on DMC Safety Analysis
Companies:Spectrum Pharmaceuticals, Inc. Related Quotes
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SPPI 8.58 0.00
{"s" : "sppi","k" : "a00,a50,b00,b60,c10,g00,h00,l10,p20,t10,v00","o" : "","j" : ""} Press Release Source: Spectrum Pharmaceuticals On Monday March 28, 2011, 7:00 am
IRVINE, Calif.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals (NasdaqGS:SPPI - News), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, announced today that the independent Data Monitoring Committee (DMC), per protocol, has performed a safety and futility analysis and has recommended that the pivotal, registrational study for belinostat in relapsed or refractory Peripheral T-Cell Lymphoma, the “BELIEF” Study, continue according to protocol until 100 evaluable patients are enrolled.
“We are pleased that the DMC found through their independent review that the data supports continuation of this pivotal trial,” said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals, Inc. “Belinostat is a novel HDAC inhibitor that has the potential to play an important role in cancer therapy in a variety of indications. It has activity as a single agent and in combination at full-doses with other chemotherapy drugs in multiple cancer clinical trials, has a favorable tolerability and safety profile, and is being studied via intravenous or oral administration. We continue to enroll patients into the pivotal registrational BELIEF study.” Spectrum expects to file a rolling New Drug Application for Peripheral T-Cell Lymphoma in 2011/2012.
The interim futility analysis and safety assessments were performed after the first 45 patients were entered into the study and have received at least one dose of belinostat and had the opportunity to be followed for at least two cycles. Following its analysis of the data, the DMC recommended that the study should continue.
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 Special Protocol Assessment (SPA), as a monotherapy for relapsed or refractory Peripheral T-Cell Lymphoma (PTCL), an indication for which it has been granted Orphan Drug and Fast Track designations by the U.S. Food and Drug Administration. 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 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 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 revenues, 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 |
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