Spectrum Pharmaceuticals Announces Achievement of Primary Endpoint in Belinostat Registrational Trial
- Trial surpassed an objective response rate (ORR) of at least 20% in Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL) patients.
- The primary efficacy endpoint was established under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration.
- The Company expects NDA filing by mid-2013, and an FDA decision in 2014.
- 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.
HENDERSON, Nev.--(BUSINESS WIRE)--Dec 21, 2012 - 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 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.
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 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 applications to the FDA and other regulatory agencies may not receive approval 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.®, FUSILEV®, FOLOTYN® and ZEVALIN®, are registered trademarks of Spectrum Pharmaceuticals, Inc and its affiliates. REDEFINING CANCER CARE™ and the Spectrum Pharmaceuticals logos are trademarks owned by Spectrum Pharmaceuticals, Inc.
© 2012 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
Contact: For Spectrum Pharmaceuticals, Inc.
Shiv Kapoor, 702-835-6300
Vice President, Strategic Planning & Investor Relations
Posted: December 2012