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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Spectrum Pharmaceuticals Inc | NASDAQ:SPPI | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
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0.00 | 0.00% | 1.03 | 1.14 | 0.9785 | 0 | 01:00:00 |
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 key presentations of clinical and scientific data related to its products at the 56th Annual Meeting of the American Society of Hematology (ASH), being held in San Francisco, California, from December 6-9, 2014.
For more information about the ASH annual meeting and for a complete list of abstracts, please refer to the conference website at https://ash.confex.com/ash/2014/webprogram/start.html.
The following are key abstracts being presented at the ASH meeting:
ZEVALIN® (ibritumomab tiuxetan) Injection-related AbstractsAbstract #
Type Title First AuthorDate/Time Location
1762 Poster Phase II study of Yttrium-90 Ibritumomab Tiuxetan (Zevalin) in Patients with Previously Untreated Marginal Zone Lymphoma FabregasSaturday, Dec 6,
5:30 PM-7:30 PM
West Building, Level 1
(Moscone Center)
1746 Poster Consolidative Radioimmunotherapy after Chemoimmunotherapy in Patients with Histologic Transformation of Indolent Lymphoma ReaganSaturday, Dec 6,
5:30 PM-7:30 PM
West Building, Level 1
(Moscone Center)
1733 Poster Short Course of Bendamustine and Rituximab followed by Yttrium-90 Ibritumomab Tiuxetan in Patients with Chemotherapy-Naïve Follicular Lymphoma: Results of Fol-BRITe LansiganSaturday, Dec 6,
5:30 PM-7:30 PM
West Building, Level 1
(Moscone Center)
3986 Poster Minimum Tolerable Interval of Radioimmunotherapy and Autologous Stem Cell Transplantation after High-Dose Chemotherapy for Relapsed or Refractory Aggressive B Cell Non-Hodgkin-Lymphoma Provides Excellent Disease Control HasenkampMonday, Dec 8,
6:00 PM-8:00 PM
North Building, Hall E
(Moscone Center)
4455 Poster Yttrium-90 Ibritumomab Tiuxetan for Non-Hodgkin Lymphoma: Results after a Median Follow-up of 5 Years in a Single Institution Anastasia Monday, Dec 8,6:00 PM-8:00 PM
West Building, Level 1
(Moscone Center)
4414 Poster Long term follow up of SWOG S0313: Ibritumomab Tiuxetan Consolidation after 3 Cycles of CHOP Plus Radiotherapy for High Risk Limited Stage Aggressive B-Cell Lymphoma Persky Monday, Dec 8,6:00 PM-8:00 PM
West Building, Level 1
(Moscone Center)
Beleodaq® (belinostat) for Injection-related Abstracts Abstract # Type Title First Author Location 3075 Poster Safe and Effective Treatment of Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma (PTCL) and Low Baseline Platelet Counts with Belinostat Savage Sunday, Dec. 7,6:00 PM-8:00 PM
West Building, Level 1
(Moscone Center)
265 Oral Big Data Approach to Identify Molecular Basis for Drug Sensitivity Phenotypes in Acute Myeloid Leukemia Su-In Lee Monday, Dec. 8,7:00 AM-8:30 AM
South Building, Esplanade 301 (Moscone Center)
N/A Publication Subsequent Hematopoietic Stem Cell Transplantation in Belinostat-treated Patients with Relapsed/Refractory Peripheral T-cell Lymphoma (R/R PTCL) Shustov Publication only PTCL-related Abstracts Abstract # Type Title First Author Location4434
Poster COMPLETE Registry- Patient Characteristics and Treatment Patterns in United States for the Most Common Subtypes of Peripheral T-Cell Lymphoma Pinter-Brown Monday, Dec. 8,6:00 PM-8:00 PM
West Building, Level 1
(Moscone Center)
Marqibo® (vinCRIStine sulfate LIPOSOME injection)-related Abstracts Abstract #
Type
Title First Author Location 4420
Poster
Liposomal Formulation of Vincristine Allows for Doubling the Dose Compared to Conventional Vincristine: Results of the First Futility Analysis of the OPTIMAL>60 Study of the German High-Grade Non-Hodgkin Lymphoma Study Group (DSHNHL) Duecker Monday, Dec. 8,6:00 PM-8:00 PM
West Building, Level 1
(Moscone Center)
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 five oncology drugs: FUSILEV® (levoleucovorin) for Injection; FOLOTYN® (pralatrexate injection); ZEVALIN® (ibritumomab tiuxetan) Injection for intravenous use; MARQIBO® (vinCRIStine sulfate LIPOSOME injection) for intravenous infusion; and BELEODAQ® (belinostat) for Injection. 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.
About ZEVALIN 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 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 BELEODAQ®
Beleodaq is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from the lysine residues of histones and some non-histone proteins. In vitro, belinostat caused the accumulation of acetylated histones and other proteins, inducing cell cycle arrest and/or apoptosis of some transformed cells. Belinostat shows preferential cytotoxicity towards tumor cells compared to normal cells. Belinostat inhibited the enzymatic activity of histone deacetylases at nanomolar concentrations (<250 nM).
Please see Beleodaq Full Prescribing Information at www.beleodaq.com.
Indications and Usage
Beleodaq is a histone deacetylase inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on tumor response rate and duration of response. An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.
Important Beleodaq Safety Information
Warnings and Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
About MARQIBO®
MARQIBO is a novel, sphingomyelin/cholesterol liposome-encapsulated, formulation of vincristine sulfate. Vincristine, a microtubule inhibitor, is FDA-approved for the treatment of adult patients with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies. (The encapsulation technology, utilized in this formulation, has been shown to provide prolonged circulation of vincristine in the blood).
Please see important safety information below and the full prescribing information for MARQIBO at www.marqibo.com.
Indication and usage
MARQIBO is a liposomal vinca alkaloid indicated for the treatment of adult patients with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies. This indication is based on overall response rate. Clinical benefit such as improvement in overall survival has not been verified.
Important safety information
CONTRAINDICATIONS
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®, ZEVALIN®, MARQIBO®, and BELEODAQ® 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. Any other trademarks are the property of their respective owners.
© 2014 Spectrum Pharmaceuticals, Inc. All Rights Reserved
Spectrum PharmaceuticalsShiv KapoorVice President, Strategic Planning & Investor Relations702-835-6300InvestorRelations@sppirx.com
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