Spectrum Pharmaceuticals Highlights 19 Abstracts at the 54th Annual Meeting of the American Society of Hematology (ASH), Atlanta, Georgia, December 8-11, 2012

pan>)--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 at the 54th Annual Meeting
of the American Society of Hematology (ASH), being held in Atlanta,
Georgia, from December 8-11, 2012. The presentations include two oral
presentations and 10 poster presentations for ZEVALIN (ibritumomab
tiuxetan) injection for intravenous use, three poster presentations for
FOLOTYN (pralatrexate injection), and four poster presentations for
belinostat, a novel histone deacetylase (HDAC) inhibitor.
“Nearly 20 presentations at ASH will feature clinical and scientific
data for Spectrums commercial products, ZEVALIN and FOLOTYN, as well as
our late-stage drug candidate, belinostat”
Nearly 20 presentations at ASH will feature clinical and scientific
data for Spectrums commercial products, ZEVALIN and FOLOTYN, as well as
our late-stage drug candidate, belinostat, said Rajesh C. Shrotriya,
M.D., Chairman, President and Chief Executive Officer of Spectrum
Pharmaceuticals, Inc. The ZEVALIN-related abstracts demonstrate its use
in a multitude of diverse settings and potential indications in which
this product is being tested, including transplantation, its use in
elderly patients, in frontline treatment and in the treatment of
relapsed/refractory disease, as well as in new drug combinations. The
FOLOTYN-related abstracts include presentations on new, synergistic
combinations with other approved agents and in difficult-to-treat
indications, such as HTLV-1-induced leukemia/lymphoma, while
belinostat-related presentations are studying new combinations and
indications, such as in refractory AML/MDS, as well as research on this
promising drug candidates mechanism of action.
For more information about the ASH annual meeting and for a complete
list of abstracts, please refer to the conference Web site at https://ash.confex.com/ash/2012/webprogram/start.html.
The following are key ZEVALIN-related abstracts being presented at the
ASH meeting:

Abstract #

Type

Title

First Author

Date/Time
Location
1978

Poster

Autologous Stem Cell Transplantation with Yttriumm-90-Ibritumomab
Tiuxetan (Zevalin) Plus BEAM Conditioning in Patients with
Refractory Non-Hodgkin Diffuse Large B-Cell Lymphoma: Results of a
Prospective, Multicenter, Phase II Clinical Trial

Briones

Saturday, Dec. 8
5:30 PM-7:30 PM

Hall B1-B2
2742

Poster

RIT with 90Y Ibritumomab Tiuxetan in Patients with Non-Hodgkin
Lymphoma Over 65 Years

Andrade

Sunday, Dec. 9,
6:00 PM-8:00 PM

Hall B1-B2
2687

Poster

A Phase II Trial of R-CHOP Followed by Zevalin Radioimmunotherapy
for Patients with Previously Untreated Stages I and II CD20+ Diffuse
Large Cell Non-Hodgkins Lymphoma: an Eastern Cooperative Oncology
Group Study (E3402)

Witzig

Sunday, Dec. 9,
6:00 PM-8:00 PM

Hall B1-B2
2726

Poster

90-Yttrium Ibritumomab Tiuxetan (Zevalin) and BEAM Chemotherapy
(Z-BEAM) Vs BEAM for Autologous Stem Cell Transplantation in
Lymphoma: Toxicity and Long Term Outcome From a Retrospective
Multicentric Study of 123 Patients

Terriou

Sunday, Dec. 9,
6:00 PM-8:00 PM

Hall B1-B2
2729

Poster

Rituximab-PECC Induction Followed by 90y-Ibritumomab Tiuxetan
Consolidation in Relapsed or Refractory DLBCL Patients Who Are Not
Eligible for or After ASCT: Preliminary Results From a Phase II
HOVON Study

Lugtenburg

Sunday, Dec 9,
6:00 PM-8:00 PM

Hall B1-B2
2753

Poster

Phase I Trial of Combination Therapy with 90y Ibritumomab Tiuxetan
and Gemcitabine in Patients with Non-Hodgkins Lymphoma, Final Report

Borghaei

Sunday, Dec. 9,
6:00 PM-8:00 PM

Hall B1-B2
3019

Poster

Collection of Hematopoietic Stem Cells After Previous Exposure to
Ittrium-90 Ibritumumab Tiuxetan (Zevalin) Is Feasible and Does Not
Impair Autologous Stem Cell Transplantation Outcome in Follicular
Lymphoma

Derenzini

Sunday, Dec. 9,
6:00 PM-8:00 PM

Hall B1-B2
747

Oral

Nordic MCL3 Study: Zevalin Combined with High-Dose Chemotherapy
Followed by Autologous Stem Cell Support As Late Intensification for
Mantle Cell Lymphoma (MCL) Patients > 66 Years Not in CR After
Induction Chemoimmunotherapy: No Benefit of Zevalin

Kolstad

Monday, Dec. 10, 5:00 PM

B312-B313a
3657

Poster

Short Course of Bendamustine and Rituximab Followed by
90Y-Ibritumomab Tiuxetan in Patients with Chemotherapy-Nave
Follicular Lymphoma: Early Results of Fol-Brite

Lansigan

Monday, Dec. 10,
6:00 PM-8:00 PM

Hall B1-B2
3648

Poster

FDG-PET/CT Early After 90Y-Ibritumomab Tiuxetan Therapy Predicts
Outcome in Relapsed or Refractory Indolent B-Cell Lymphoma

Okada

Monday, Dec. 10,
6:00 PM-8:00 PM

Hall B1-B2
3681

Poster

Sustained Immune Competency and Long Term Molecular Remissions in FL
Patients with FLIPI Risk Factors 1, Treated Front Line with R-CHOP
Followed by Consolidative 90 -Radioimmunotherapy and Maintenance
Rituximab

Berinstein

Monday, Dec. 10,
6:00 PM-8:00 PM

Hall B1-B2
812

Oral

Upfront Consolidation Combining Yttrium-90 Ibritumomab Tiuxetan and
High Dose Therapy with Stem-Cell Transplantation in Poor Risk
Patients with Diffuse Large B-Cell Lymphoma

Fruchart

Monday, Dec. 10
6:30 PM

B312-B313a

The following are key FOLOTYN-related abstracts being presented at the
ASH meeting:

Abstract #

Type

Title

First Author

Location
2735

Poster

Pralatrexate in Relapsed/Refractory HTLV-1 Associated Adult T-Cell
Lymphoma/Leukemia: A New York City Multi-Institutional Experience

Lunning

Sunday, Dec. 9,
6:00 PM-8:00 PM

Hall B1-B2
2758

Poster

Novel Imaging Modalities in Innovative Xenograft Mouse Models of
T-Cell Lymphoma Confirm Marked Synergy of Romidepsin and Pralatrexate

Jain

Sunday, Dec. 9,
6:00 PM-8:00 PM

Hall B1-B2
3660

Poster

Cutaneous Toxicity Associated with Pralatrexate in Cutaneous and
Peripheral T-Cell Lymphoma

Parker

Monday, Dec. 10,
6:00 PM-8:00 PM

Hall B1-B2

The following are key belinostat-related abstracts being presented at
the ASH conference:

Abstract #

Type

Title

First Author

Location
1359

Poster

Mechanisms of Sensitivity and Resistance to Histone Deacetylase
Inhibitors in Diffuse Large B-Cell Lymphoma

Tula-Sanchez

Saturday, Dec. 8,
5:30 PM-7:30 PM

Hall B1-B2
2725

Poster

Sirtuin Inhibition in Combination with Histone Deacetylase (HDAC)
Inhibition Is Effective Therapy for Aggressive B-Cell Lymphomas in
Both Pre-Clinical and Clinical Studies of Disease

Amengual

Sunday, Dec. 9,
6:00 PM-8:00 PM

Hall B1-B2
3588

Poster

Phase I Trial of Belinostat and Bortezomib in Patients with Relapsed
or Refractory Acute Leukemia, Myelodysplastic Syndrome, or Chronic
Myelogenous Leukemia in Blast Crisis - One Year Update

Holkova

Monday, Dec. 10,
6:00 PM-8:00 PM

Hall B1-B2
3891

Poster

Inhibition of Histone Deacetylase Activity Compromises Homologous
Recombination Repair and Increases Sensitivity of Chemo-Resistant
Chronic Lymphocytic Leukemia Cells to Olaparib

Agathanggelou

Monday, Dec. 10,
6:00 PM-8:00 PM

Hall B1-B2

About Non-Hodgkins Lymphoma
According to the National Cancer Institute (www.cancer.gov),
there are expected to be 70,130 new cases of non-Hodgkins lymphoma
diagnosed and approximately 18,940 deaths in the United States in 2012.
Non-Hodgkins lymphoma is defined as any of a large group of cancers of
lymphocytes (white blood cells). Non-Hodgkins 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-Hodgkins
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 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-Hodgkins lymphoma (NHL). ZEVALIN is
also indicated for the treatment of patients with previously untreated
follicular non-Hodgkins 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 FOLOTYN
FOLOTYN, (pralatrexate injection), a folate analogue metabolic
inhibitor, was discovered by Memorial Sloan-Kettering Cancer Center, SRI
International and Southern Research Institute and developed by Allos
Therapeutics. In September 2009, the U.S. Food and Drug Administration
(FDA) granted accelerated approval for FOLOTYN for use as a single agent
for the treatment of patients with relapsed or refractory PTCL. This
indication is based on overall response rate. Clinical benefit such as
improvement in progression-free survival or overall survival has not
been demonstrated. FOLOTYN has been available to patients in the U.S.
since October 2009. An updated analysis of data from PROPEL, the pivotal
study of FOLOTYN in patients with relapsed or refractory PTCL, was
published in the March 20, 2011 issue of the Journal of Clinical
Oncology. FOLOTYN has patent protection through July 2022, based on a
five-year patent term extension through the Hatch-Waxman Act. Please see
full Prescribing Information for FOLOTYN at www.FOLOTYN.com.
Important FOLOTYN Safety Information
Warnings and Precautions
FOLOTYN may suppress bone marrow function, manifested by
thrombocytopenia, neutropenia, and anemia. Monitor blood counts and omit
or modify dose for hematologic toxicities.
Mucositis may occur. If greater-than or equal to Grade 2 mucositis is
observed, omit or modify dose. Patients should be instructed to take
folic acid and receive vitamin B12 to potentially reduce
treatment-related hematological toxicity and mucositis.
Fatal dermatologic reactions may occur. Dermatologic reactions may be
progressive and increase in severity with further treatment. Patients
with dermatologic reactions should be monitored closely, and if severe,
FOLOTYN should be withheld or discontinued. Tumor lysis syndrome may
occur. Monitor patients and treat if needed.
FOLOTYN can cause fetal harm. Women should avoid becoming pregnant while
being treated with FOLOTYN and pregnant women should be informed of the
potential harm to the fetus.
Use caution and monitor patients when administering FOLOTYN to patients
with moderate to severe renal function impairment.
Elevated liver function test abnormalities may occur and require
monitoring. If liver function test abnormalities are greater-than or
equal to Grade 3, omit or modify dose.
Adverse Reactions
The most common adverse reactions were mucositis (70%), thrombocytopenia
(41%), nausea (40%), and fatigue (36%). The most common serious adverse
events are pyrexia, mucositis, sepsis, febrile neutropenia, dehydration,
dyspnea, and thrombocytopenia.
Use in Specific Patient Population
Nursing mothers should be advised to discontinue nursing or the drug,
taking into consideration the importance of the drug to the mother.
Drug Interactions
Co-administration of drugs subject to renal clearance (e.g., probenecid,
NSAIDs, and trimethoprim/sulfamethoxazole) may result in delayed renal
clearance.
Please see FOLOTYN Full Prescribing Information at www.FOLOTYN.com.
About Belinostat
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
U.S. Food and Drug Administration (FDA), Spectrums 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, multicenter, 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 overall 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. Spectrums 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 managements 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, Spectrums 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 Companys 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.

Information Source: Business Wire

December 8th, 2012 @ 05:35pm