Spectrum Pharmaceuticals’ Pivotal Trial of Captisol-Enabled™ (Propylene Glycol-Free) Melphalan Meets Primary Endpoint
April 23 2014 - 7:00AM
Business Wire
- CE Melphalan is being developed as a
novel version of the well-established conditioning treatment in
autologous transplant for patients with multiple myeloma. CE
Melphalan does not contain propylene glycol, an ingredient in
currently available products which has been associated with renal
and cardiac side effects.
- In its pivotal trial, CE Melphalan
met its primary endpoint. The improved stability profile of CE
Melphalan could lead to rapid adoption in the transplant
conditioning market.
- The company expects to file an NDA
in the 3rd quarter and plans to launch this drug with its existing
hematology/oncology sales force next year pending
approval.
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 that its pivotal trial of Captisol-enabled™ (propylene
glycol-free) Melphalan met its primary end points.
“I am pleased with the focus and alacrity in which our clinical
team has executed this trial,” said Rajesh C. Shrotriya, MD,
Chairman and Chief Executive Officer of Spectrum Pharmaceuticals.
“With the positive results from this trial, we are one step closer
to providing patients and healthcare providers with a much needed
new formulation of Melphalan. Melphalan is currently a
well-established conditioning treatment in autologous transplant
for patients with multiple myeloma. Our novel Captisol-enabled
Melphalan is free of propylene glycol, which itself is associated
with renal and cardiac side effects. Additionally, the improved
stability profile of CE Melphalan could be valuable in its rapid
adoption in the transplant conditioning market. This product also
fits seamlessly into our existing commercial and research
infrastructure. With key upcoming catalysts related to CE
Melphalan, Beleodaq and SPI-2012, we continue to be committed to
building a world-class Hematology/Oncology company.”
The phase 2 pivotal trial evaluating CE Melphalan was a
multi-center trial evaluating safety and efficacy. The primary
objective of the study was to determine the overall safety and
toxicity profile in multiple myeloma patients receiving 200 mg/m2
of CE Melphalan as myeloablative therapy prior to autologous stem
cell transplantation (ASCT). The secondary objectives evaluated the
efficacy of CE Melphalan in this patient population as measured by
multiple myeloma response rate (according to International Myeloma
Working Group [IMWG] criteria), and the rates of myeloablation, and
engraftment. The primary endpoint of this Phase 2 trial was met,
and additional analyses are currently underway. The company plans
to file an NDA in the third quarter.
In a previous clinical study, Captisol-enabled Melphalan met the
requirements for establishment of bioequivalence to the current
commercial intravenous formulation of melphalan.
Spectrum Pharmaceuticals gained global development and
commercialization rights to CE Melphalan from Ligand
Pharmaceuticals Incorporated (NASDAQ: LGND) in March 2013.
Spectrum assumed the responsibility for the pivotal clinical trial
and is responsible for filing an NDA. Under the license agreement,
Ligand received a license fee and is eligible to receive milestone
payments, as well as royalties following potential
commercialization.
About Captisol-Enabled Melphalan
Captisol-enabled, PG-free melphalan is a novel intravenous
formulation of melphalan being investigated for the multiple
myeloma transplant setting, for which it has been granted an Orphan
Drug Designation by the FDA. This formulation eliminates the use of
propylene glycol, which has been reported to cause renal and
cardiac side effects that limit the ability to deliver higher doses
of therapeutic compounds. The use of the Captisol® technology to
reformulate melphalan also improves its stability and is
anticipated to allow for slower infusion rates and longer
administration durations, potentially enabling clinicians to safely
achieve a higher dose intensity for pre-transplant
chemotherapy.
About Captisol®
Captisol is a patent-protected, chemically modified cyclodextrin
with a structure designed to optimize the solubility and stability
of drugs. Captisol was invented and initially developed by
scientists in the laboratories of Dr. Valentino Stella at the
University of Kansas’ Higuchi Biosciences Center for specific use
in drug development and formulation. This unique technology has
enabled six FDA-approved products, including Onyx Pharmaceuticals’
Kyprolis®, Baxter International’s Nexterone® and Merck’s NOXAFIL
IV. There are also more than 30 Captisol-enabled products currently
in clinical development.
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 four oncology drugs ─ FUSILEV®
(levoleucovorin) for Injection in the U.S.; FOLOTYN® (pralatrexate
injection), also marketed in the U.S.; ZEVALIN® (ibritumomab
tiuxetan) Injection for intravenous use, for which the Company has
worldwide marketing rights and MARQIBO® (vinCRIStine sulfate
LIPOSOME injection) for intravenous infusion, 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®, ZEVALIN®
and MARQIBO® are registered trademarks of Spectrum Pharmaceuticals,
Inc and its affiliates. BELEODAQ™, 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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