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Previous Phase 1/2 Combination Study Resulted in Overall Response Rate of 86%, Complete Response Rate of 64% in Rituximab-Refractory Patients MGd Shown to Have Synergistic Effect w...

Thu, 05/17/2012 - 3:45am
The Associated Press

HENDERSON, Nev.--(BUSINESS WIRE)--May 17, 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 the initiation of a Phase 2 study evaluating ZEVALIN(R) (ibritumomab tiuxetan) Injection for intravenous use + rituximab in combination with motexafin gadolinium (MGd) in patients with rituximab-refractory low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL). MGd is a redox modulating agent designed to selectively accumulate in cancer cells and interact with intracellular reducing metabolites, producing reactive oxygen species that can disrupt cell function and cause apoptosis (cell death). Results of a previous Phase 1/2 pilot study demonstrated that the combination of ZEVALIN regimen with MGd was well-tolerated and resulted in an overall response rate (ORR) of 86%, a complete response (CR) rate of 64% and the median time to treatment failure of 14-months in the rituximab-refractory follicular lymphoma patients group (n=14). Of particular note, all responses to the ZEVALIN/MGd combination were documented within 4 weeks (see Evens et al., Clinical Cancer Research, 2009).

"The commencement of the Phase 2 trial advances our strategy to explore new ways of using the ZEVALIN regimen in its current indication while we continue to study additional therapeutic applications to broaden the potential number of patients who can be helped by ZEVALIN, such as our Phase 3 program for the treatment of diffuse large B-Cell lymphoma," stated Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals, Inc. "MGd is a particularly promising agent for use in combination with radioimmunotherapy, having shown a synergistic treatment effect in earlier research with radiation therapy and chemotherapeutic agents. The safety database for MGd includes results from more than 1000 patients. We look forward to the progress of our recently initiated study, which is designed to confirm and extend these initial promising findings." The multicenter, randomized, open-label, Phase 2 study is designed to evaluate the safety and efficacy of the novel combination therapy. The trial is designed to enroll a total of 100 patients in North America, who will be randomized to one of two treatment arms: ZEVALIN + rituximab, and MGd, or ZEVALIN + rituximab. The treatment period will be 10-12 days, followed by 12-week safety follow up and then up to 12-month follow up. The primary endpoint is the complete response (CR) rate within 6 months of study entry, while secondary endpoints consist of CR rate within 3 months, overall response rate within 6 months, and progression-free survival.

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 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 Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc.

5/8 2012 Spectrum Pharmaceuticals, Inc. All Rights Reserved.

CONTACT: Spectrum Pharmaceuticals, Inc.

Vice President, Strategic Planning & Investor Relations Shiv Kapoor, 702-835-6300 KEYWORD: UNITED STATES NORTH AMERICA NEVADA INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY CLINICAL TRIALS ONCOLOGY PHARMACEUTICAL SOURCE: Spectrum Pharmaceuticals, Inc.

Copyright Business Wire 2012 PUB: 05/17/2012 07:00 AM/DISC: 05/17/2012 07:00 AM http://www.businesswire.com/news/home/20120517005490/

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