Spectrum Pharmaceuticals Highlights Seven Abstracts of Clinical Data at the 2012 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois, June 1-5, 2012
HENDERSON, Nev.--(BUSINESS WIRE)--May 31, 2012-- Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology and hematology, today announced key presentations of clinical data, including five ZEVALIN-related poster presentations, as well as a poster presentation and one e-abstract publication of clinical data for belinostat, at the American Society of Clinical Oncology (ASCO) Annual Meeting, being held in Chicago, Illinois, from June 1-5, 2012.
For more information about the ASCO annual meeting and for a complete list of abstracts, please refer to the conference Web site at http://abstract.asco.org/.
The following are key ZEVALIN-related abstracts being presented at the ASCO conference: Monday June 4, 2012, 1:15 PM - 5:15 PM Central Time Abstract# Type Title First Author Location 8056 Poster Effect of short-duration chemoimmunotherapy plus radioimmunotherapy on response rates in relapsed follicular lymphoma: A U.K. NCRI Lymphoma Group Study, CR UK/07/038 Illidge S HallA2 6547 Poster Effect of radioimmunotherapy-based conditioning for autologous stem cell transplantation on poor-risk molecular profiling in diffuse large B-cell lymphoma Siddiqi S HallA2 6545 Poster A phase II trial 90y-ibritumomab tiuxetan in combination with reduced intensity regimen of fludarabine (flu) and melphalan (mel) followed by allo-HCT in patients with refractory B-cell lymphoma Nademanee S HallA2 6633 Poster Phase II study of short CHOP-rituximab combination with early consolidation with ibritumomab-tiuxetan-Y90 (IT-Y90) in non-pretreated patients age 65 to 80 with CD20+ diffuse large B-cell lymphoma (DLBCL) Peyrade S HallA2 6543 Poster Minimum tolerable interval of 90yttrium ibritumomab-tiuxetan to autologous stem cell transplantation after high-dose chemotherapy with carmustin, etoposide, cytarabine, and melphalan for relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma Hasenkamp S HallA2 The following are key belinostat-related abstracts: Saturday June 2, 2012, 1:15 PM to 5:15 PM Central Time Abstract# Type Title First Author Location 7103 Poster A phase (Ph) I/II study of belinostat (Bel) in combination with cisplatin, doxorubicin, and cyclophosphamide (PAC) in the first-line treatment of advanced or recurrent thymic malignancies. Thomas S HallA2 Publication Abstract Abstract# Type Title First Author Location e18536 Publication A phase II study of PXD101 (belinostat) in relapsed and refractory aggressive B-cell lymphomas (rel/ref ABCL): SWOG S0520 Persky NA About Non-Hodgkin's Lymphoma According to the National Cancer Institute (www.cancer.gov), there are expected to be 70,130 new cases of non-Hodgkin's lymphoma diagnosed and approximately 18,940 deaths in the United States in 2012.
Non-Hodgkin's lymphoma is defined as any of a large group of cancers of lymphocytes (white blood cells). Non-Hodgkin's lymphomas can occur at any age and are often marked by lymph nodes that are larger than normal, fever, and weight loss. There are many different types of non-Hodgkin's lymphoma. These types can be divided into aggressive (fast-growing) and indolent or low grade (slow-growing) types, and they can be formed from either B-cells or T-cells. Prognosis and treatment depend on the stage and type of disease.
About ZEVALIN (R) and the ZEVALIN Therapeutic Regimen ZEVALIN (ibritumomab tiuxetan) Injection for intravenous use is indicated for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL). ZEVALIN is also indicated for the treatment of patients with previously untreated follicular non-Hodgkin's Lymphoma who achieve a partial or complete response to first-line chemotherapy.
ZEVALIN is a CD20-directed radiotherapeutic antibody. The ZEVALIN therapeutic regimen consists of two components: rituximab, and Yttrium-90 (Y-90) radiolabeled ZEVALIN for therapy. ZEVALIN builds on the combined effect of a targeted biologic monoclonal antibody augmented with the therapeutic effects of a beta-emitting radioisotope.
Important ZEVALIN (R) Safety Information Deaths have occurred within 24 hours of rituximab infusion, an essential component of the ZEVALIN therapeutic regimen. These fatalities were associated with hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, or cardiogenic shock. Most (80 fatalities occurred with the first rituximab infusion. ZEVALIN administration can result in severe and prolonged cytopenias in most patients. Severe cutaneous and mucocutaneous reactions, some fatal, can occur with the ZEVALIN therapeutic regimen.
Please see full Prescribing Information, including BOXED WARNINGS, for ZEVALIN and rituximab. Full prescribing information for ZEVALIN can be found at www.ZEVALIN.com.
About Belinostat Belinostat (PXD 101) 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 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 peripheral T-cell lymphoma (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, a biotechnology company with a primary focus in oncology and hematology, currently markets two oncology drugs, FUSILEV(R) (levoleucovorin) for Injection and ZEVALIN(R) (ibritumomab tiuxetan) Injection for intravenous use. In addition, Spectrum has two drugs, belinostat and apaziquone, in late-stage development and a diversified pipeline of novel drug candidates in earlier stages of development. The Company's strategy is comprised of acquiring, developing and commercializing a broad and diverse pipeline of late-stage clinical and commercial drug products. The Company has aggressive business development and commercial operation teams that support a robust drug development program encompassing clinical development, medical research, regulatory affairs, biostatistics and data management. 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 applications to the FDA may not receive approval, 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.(R), ZEVALIN(R), and FUSILEV(R) are registered trademarks of Spectrum Pharmaceuticals, Inc. REDEFINING CANCER CARE(TM) and the Spectrum Pharmaceuticals logos are trademarks owned by Spectrum Pharmaceuticals, Inc.
5/8 2012 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
CONTACT: Spectrum Pharmaceuticals Shiv Kapoor, 702-835-6300 Vice President, Strategic Planning & Investor Relations InvestorRelations@sppirx.com KEYWORD: UNITED STATES NORTH AMERICA ILLINOIS NEVADA INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY CLINICAL TRIALS SOURCE: Spectrum Pharmaceuticals Copyright Business Wire 2012 PUB: 05/31/2012 07:02 AM/DISC: 05/31/2012 07:02 AM http://www.businesswire.com/news/home/20120531005574/