Spectrum Pharmaceuticals Announces Achievement of Primary Endpoint in
Belinostat Registrational Trial
*Trial surpassed an objective response rate (ORR) of at least 20% in
Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL) patients.
*The primary efficacy endpoint was established under a Special Protocol
Assessment agreement with the U.S. Food and Drug Administration.
*The Company expects NDA filing by mid-2013, and an FDA decision in 2014.
*The complete safety evaluation has been accepted for presentation at the
T- Cell Lymphoma Forum to be held in San Francisco, Jan 24-26, 2013.
HENDERSON, Nev. -- December 21, 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 surpassing the primary endpoint in
the pivotal, registrational Phase 2 BELIEF trial of belinostat, a pan-histone
deacetylase (HDAC) inhibitor.
The BELIEF trial is evaluating the efficacy and safety of intravenous
belinostat for the treatment of patients with relapsed/refractory peripheral
T-cell lymphoma (PTCL). The BELIEF trial surpassed an objective response rate
(ORR) of at least 20% in these patients, the study’s primary efficacy endpoint
as established under a Special Protocol Assessment (SPA) agreement with the
U.S. Food and Drug Administration (FDA). The complete safety evaluation has
been accepted for presentation at the T-Cell Lymphoma Forum to be held in San
Francisco, Jan 24-26, 2013.
“Belinostat is an important compound in our late-stage development pipeline,
and we are pleased to confirm the trial achieved its primary endpoint,” stated
Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of
Spectrum Pharmaceuticals, Inc. "We expect additional efficacy and safety
findings will be presented at a major upcoming medical conference.
Furthermore, based on our current timeline, we anticipate filing the NDA by
the middle of next year, with a potential action date from the FDA 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.
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 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, international, 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
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.
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, Inc.
© 2012 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
For Spectrum Pharmaceuticals, Inc.
Shiv Kapoor, 702-835-6300
Vice President, Strategic Planning & Investor Relations
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