Spectrum Pharmaceuticals Announces Agreement with FDA on the Special Protocol Assessment (SPA) for the Registrational Trial o...
December 16 2015 - 7:00AM
Business Wire
- Registrational, randomized,
active-controlled Phase 3 study (ADVANCE) will study SPI-2012 as a
treatment for chemotherapy-induced neutropenia in approximately 580
patients with breast cancer.
- The company expects to start the
pivotal trial soon and plans to complete enrollment in
2017.
- SPI-2012 is a novel, long-acting
granuloctye colony-stimulating factor (G-CSF) that utilizes a
proprietary platform technology to maximize the pharmacological
activity of G-CSF, resulting in increased potency and a prolonged
half-life.
- The worldwide commercial opportunity
for the treatment of chemotherapy-induced neutropenia is over $6
billion.
Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology
company with fully integrated commercial and drug development
operations, and a primary focus in Hematology and Oncology,
announced today that the company has reached agreement with the
U.S. Food and Drug Administration (FDA) on the Special Protocol
Assessment (SPA) for the Phase 3 clinical trial of its novel,
long-acting G-CSF, SPI-2012 (eflapegrastim). This trial will
evaluate the safety and efficacy of SPI-2012 as a treatment for
chemotherapy-induced neutropenia in patients with breast cancer,
and will serve as the basis for the Biologics License Application
(BLA) filing.
“We are excited to have reached agreement with the FDA on the
SPI-2012 SPA, which is the highest priority program at Spectrum,”
said Rajesh C. Shrotriya, MD, Chairman and Chief Executive
Officer of Spectrum Pharmaceuticals. “SPI-2012 is a novel
proprietary biologic that has been shown in a Phase 2 clinical
trial to be more potent than pegfilgrastim, and consists of a
novel, recombinant G-CSF conjugated, using a technology that
enhances the half-life of this therapeutic protein. Our team has
been ready to start this registrational Phase 3 trial, and plans to
aggressively drive study enrollment. Spectrum has built a strong
clinical team and commercial infrastructure with expertise in the
treatment of neutropenia. If approved, we believe this drug will
enable us to compete in a blockbuster market and change the face of
our Company.”
In accordance with the SPA, this registrational, Phase 3 trial,
or ADVANCE study (RAnDomized Trial of SPI-2012 Versus Pegfilgrastim in the Management of
Chemotherapy Induced Neutropenia in Breast CANCEr Patients Receiving Docetaxel and
Cyclophosphamide) will be a multicenter, randomized, active
controlled trial that will enroll 580 newly diagnosed early-stage
breast cancer patients, who will receive adjuvant or neoadjuvant
chemotherapy every 21 days. Adjuvant chemotherapy is treatment
given after primary surgical therapy to kill any remaining cancer
cells and increase the chance of long-term disease-free survival;
neoadjuvant chemotherapy is the administration of cytotoxic agents
before surgical resection in early-stage breast cancer to shrink
the tumor and potentially allow for breast-conserving surgery.
SPI-2012 will be administered subcutaneously as a fixed dose
equivalent to 3.6 mg of GCSF, which was selected based on the
robust pharmacological and pharmacodynamic data from Phase 2. The
primary study endpoint is the Duration of Severe Neutropenia
(Absolute Neutrophil Counts [ANC] <0.5×109/L) in Cycle 1 of
chemotherapy, based on central laboratory assessment of ANC over
the 21 day cycle. Secondary endpoints include the Incidence of
Neutropenic Complications, Incidence of Febrile Neutropenia,
Relative Dose Intensity, and safety.
About Special Protocol Assessments
A Special Protocol Assessment is a written agreement between a
Sponsor and the U.S. Food and Drug Administration on the design,
execution and analysis for a clinical trial that may form the basis
of a new Biologics License application or BLA. Final marketing
approval depends upon the efficacy results, safety profile and an
evaluation of the risk/benefit of treatment demonstrated in the
Phase 3 clinical program.
About Breast Cancer
According to the American Cancer Society (ACS), breast cancer is
the second most common form of cancer in women after skin cancer,
and the second highest cause of female cancer deaths after lung
cancer. Unfortunately, it is estimated that about 1 in 8 (12%) of
women in the US will develop invasive breast cancer during their
lifetime. In 2015 in the United States (US), an estimated 231,840
new cases of invasive breast cancer and 60,290 additional cases of
in situ breast cancer will be diagnosed, and approximately 40,290
US women are expected to die from breast cancer. In addition,
~2,350 men are also expected to be diagnosed with breast cancer in
2015 with an estimated 440 deaths.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a leading biotechnology company
focused on acquiring, developing, and commercializing drug
products, with a primary focus in Hematology and Oncology. Spectrum
currently markets five hematology/oncology drugs, and expects an
FDA decision on another hematology drug in the first half of 2016.
Additionally, Spectrum's pipeline includes three drugs targeting
blockbuster markets in advanced stages of clinical development.
Spectrum's strong track record for 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®, ZEVALIN®,
MARQIBO®, and BELEODAQ® are registered trademarks of Spectrum
Pharmaceuticals, Inc and its affiliates. REDEFINING CANCER CARE™,
EVOMELA™ and the Spectrum Pharmaceuticals logos are trademarks
owned by Spectrum Pharmaceuticals, Inc. Any other trademarks are
the property of their respective owners.
© 2015 Spectrum Pharmaceuticals, Inc. All Rights Reserved
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Spectrum PharmaceuticalsShiv KapoorVice President, Strategic
Planning & Investor
Relations702-835-6300InvestorRelations@sppirx.com
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