Spectrum Pharmaceuticals Provides Update on Belinostat Registrational Trial for the Treatment of Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL)
Final analysis of the Belinostat Registrational Trial has not been
made and 7 patients continue on treatment
Database lock is expected to occur in November/December 2012, with
definitive determination of the primary endpoint of objective overall
response rate (ORR) to follow
Pending final data analysis and agreement with the FDA, NDA filing
is anticipated by mid-2013, and an FDA decision is likely in 2014
HENDERSON, Nev.--(BUSINESS WIRE)--
Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company
with fully integrated commercial and drug development operations with a
primary focus in oncology and hematology, today provided an update
regarding anticipated milestones for the analysis of data and potential
regulatory filing related to the pivotal, registrational BELIEF trial of
belinostat, a novel histone deacetylase (HDAC) inhibitor. On September
21, 2012, Topotarget A/S, Spectrum's collaboration partner for the joint
development of belinostat, reported preliminary clinical results for the
BELIEF trial, which is evaluating the efficacy and safety of belinostat
for the treatment of patients with relapsed/refractory peripheral T-cell
lymphoma (PTCL). Spectrum is continuing to collect and analyze the data
from the trial, and database lock is expected to occur in
November/December 2012, following which a definitive determination of
the primary endpoint of overall response rate (ORR) will be calculated.
"We are very pleased with the ongoing data collection and its analysis
from the BELIEF trial and look forward to a required meeting with the
FDA once a definitive ORR has been determined," stated Rajesh C.
Shrotriya, M.D., Chairman, President and Chief Executive Officer of
Spectrum Pharmaceuticals, Inc. "Pending final data analysis and
agreement with the FDA, we anticipate filing of an NDA application by
mid-2013, and FDA decision is likely in 2014."
About Peripheral T-Cell Lymphoma
According to the Lymphoma Research Foundation (www.lymphoma.org),
lymphoma is the most common blood cancer. The two main forms of lymphoma
are Hodgkin's lymphoma and non-Hodgkin's lymphoma (NHL). Lymphoma occurs
when lymphocytes, a type of white blood cell, grow abnormally where they
typically reside in the lymph glands. The body has two main types of
lymphocytes that can develop into lymphomas: B-lymphocytes (B-cells) and
T-lymphocytes (T-cells). Peripheral T-cell lymphoma (PTCL) comprises a
group of rare and aggressive NHLs that develop from mature T-cells. PTCL
accounts for approximately 10 to 15% of all NHL cases in the United
States, and projections for annual cancer incidences point to 15,500 new
cases of PTCL in the U.S., Japan, and five of the largest EU countries.
FOLOTYN® (pralatrexate injection), the first therapeutic approved for
the treatment of PTCL, is marketed by Spectrum pursuant to the Company's
recent acquisition of Allos Therapeutics, Inc.
About Belinostat and the BELIEF Trial
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), the 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. 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.
(levoleucovorin) for injection
FUSILEV, a novel folate analog, is approved as a ready-to-use solution
(FUSILEV Injection), and as freeze-dried powder (FUSILEV for Injection).
FUSILEV is indicated for use in combination chemotherapy with
5-fluorouracil in the palliative treatment of patients with advanced
metastatic colorectal cancer. FUSILEV is also indicated for rescue after
high-dose methotrexate therapy in osteosarcoma. FUSILEV is also
indicated to diminish the toxicity and counteract the effects of
impaired methotrexate elimination and of inadvertent overdosage of folic
acid antagonists. FUSILEV, under various trade names, is marketed
outside the United States by Pfizer, Sanofi-Aventis, and Takeda.
(levoleucovorin) Safety Considerations
FUSILEV is dosed at one-half the usual dose of racemic d,l-leucovorin.
FUSILEV is contraindicated for patients who have had previous allergic
reactions attributed to folic acid or folinic acid. Due to calcium
content, no more than 16-mL (160-mg) of levoleucovorin solution should
be injected intravenously per minute. FUSILEV enhances the toxicity of
fluorouracil. Concomitant use of d,l-leucovorin with
trimethoprim-sulfamethoxazole for pneumocystis carinii pneumonia in HIV
patients was associated with increased rates of treatment failure in a
placebo-controlled study. Allergic reactions were reported in patients
receiving FUSILEV. Vomiting (38%), stomatitis (38%) and nausea (19%)
were reported in patients receiving FUSILEV as rescue after high dose
methotrexate therapy. The most common adverse reactions ( > 50%) in
patients with advanced colorectal cancer receiving FUSILEV in
combination with 5-fluorouracil were diarrhea, nausea and stomatitis.
FUSILEV may counteract the antiepileptic effect of phenobarbital,
phenytoin and primidone, and increase the frequency of seizures in
Full prescribing information can be found at www.FUSILEV.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
Please see full Prescribing Information, including BOXED WARNINGS, for
ZEVALIN and rituximab. Full prescribing information for ZEVALIN can be
found at www.ZEVALIN.com.
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 2017, potentially
through July 2022, assuming 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.
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.
Co-administration of drugs subject to renal clearance (e.g., probenecid,
NSAIDs, and trimethoprim/sulfamethoxazole) may result in delayed renal
Please see FOLOTYN® Full Prescribing Information at www.FOLOTYN.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 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®, 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,
© 2012 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
Spectrum Pharmaceuticals, Inc.
Shiv Kapoor, 702-835-6300
President, Strategic Planning & Investor Relations
Source: Spectrum Pharmaceuticals, Inc.
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