Spectrum Pharmaceuticals, Inc. (NasdaqGM:SPPI), a commercial-stage biotechnology company with a primary focus in oncology and hematology, and TopoTarget A/S, today announced that the first patient has been dosed in a National Cancer Institute (NCI)-sponsored Phase 1/2 trial of belinostat in combination with cisplatin, doxorubicin and cyclophosphamide in the first line treatment of advanced or recurrent thymic malignancies. The trial is designed to determine what drug doses can be safely administered together in patients, and to make dose recommendations for future clinical trials. This trial is among the first to test the feasibility of simultaneously administering a histone deacetylase (HDAC) inhibitor, such as belinostat, with common chemotherapy agents such as cisplatin, doxorubicin, and cyclophosphamide, in the first line treatment of advanced or recurrent thymic malignancies. The study is expected to recruit between 30 and 48 evaluable patients.
"We are pleased that the NCI continues to investigate the use of belinostat in the treatment of various cancers," said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. "We believe belinostat has the potential to be an effective treatment in combination with existing chemotherapeutic agents for the treatment of thymomas, thymic malignancies, and other cancers."
More information on this Phase 1/2 study can be found at www.clinicaltrials.gov.
About Belinostat
Belinostat (PXD 101) is a novel 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 overcome drug resistance 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.
About Thymoma and Thymic Carcinoma
Thymus cancers are uncommon cancers that start in the thymus. This small organ is located just behind the breast bone in the front part of the mediastinum, the space in the chest between the lungs. The thymus is an important part of the body''s immune system. During fetal development and childhood, the thymus is involved in the production and maturation of T lymphocytes (also known as T cells), a type of white blood cell. T lymphocytes develop in the thymus and then travel to lymph nodes (bean-sized collections of immune system cells) throughout the body. There they help the immune system protect the body from viruses, fungus, and other types of infections. The thymus contains different types of cells, each of which can develop into different types of cancer: Epithelial cells give the thymus its structure and shape. They can give rise to thymomas and thymic carcinomas; Lymphocytes make up most of the rest of the thymus. Whether in the thymus or in other parts of the body, these immunes system cells can develop into cancers called Hodgkin disease and non-Hodgkin lymphomas; and Kulchitsky cells, or neuroendocrine cells, are much less common cells that normally release certain hormones. These cells can give rise to cancers called carcinoid tumors. Thymomas and thymic carcinomas are tumors that start from thymic epithelial cells.
About the Belinostat Registrational Study
Belinostat is currently in registrational trial, under a Special Protocol Assessment (SPA), as a monotherapy for Peripheral T-Cell Lymphoma (PTCL), an indication which has been granted Orphan Drug and Fast Track designation by the U.S. Food and Drug Administration (FDA). The registrational trial is in an open-label, multicenter, single arm efficacy and safety study in patients with relapsed or refractory peripheral T-cell lymphoma, who have failed at least one prior systemic therapy. The primary endpoint is objective response rate (ORR).
About the NCI
The National Cancer Institute (NCI) is part of the National Institutes of Health (NIH), which is one of 11 agencies that compose the Department of Health and Human Services (HHS). The NCI, established under the National Cancer Institute Act of 1937, is the Federal Government''s principal agency for cancer research and training. The National Cancer Act of 1971 broadened the scope and responsibilities of the NCI and created the National Cancer Program. Over the years, legislative amendments have maintained the NCI authorities and responsibilities and added new information dissemination mandates as well as a requirement to assess the incorporation of state-of-the-art cancer treatments into clinical practice.
The National Cancer Institute coordinates the National Cancer Program, which conducts and supports research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and the families of cancer patients.
About TopoTarget
TopoTarget A/S is an international biotech company headquartered in Denmark, dedicated to finding ''Answers for Cancer'' and developing improved cancer therapies. The company was founded and is run by clinical cancer specialists and combines years of hands-on clinical experience with in-depth understanding of the molecular mechanisms of cancer. For more information, please refer to www.topotarget.com.
About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals is a commercial-stage biotechnology company with a focus in oncology and hematology. The Company''s strategy is comprised of acquiring, developing and commercializing a broad and diverse pipeline of late-stage clinical and commercial products. In addition to building an efficient in-house clinical research organization with regulatory and data management capabilities, the Company has established a commercial infrastructure for its drug portfolio. The Company markets two oncology drugs, ZEVALIN® and FUSILEV® and has two drugs in late stage development, apaziquone (EOquin®) and belinostat, along with a diverse pipeline. 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, 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 around the world to assist us in the execution of our strategy, that belinostat has the potential to be an effective treatment in combination with existing chemotherapeutic agents for the treatment of thymomas, thymic malignancies, and other cancers, that Belinostat has multiple potential routes of administrationand 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.
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Contacts:
Spectrum Pharmaceuticals, Inc.
Paul Arndt, 949-788-6700 x216
Senior
Manager, Investor Relations
