Spectrum Pharmaceuticals Commences Patient Enrollment in Randomized Phase 2b Clinical Trial of Ozarelix for Hormone-Dependent Prostate Cancer
-
Encouraging Safety and Efficacy Findings From 150 Patients
Result in Company's Decision to Move Forward
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Primary Objective is to Demonstrate Ability to Consistently
Reduce Testosterone Levels to Equal or Less than Castration Levels
( < =0.5 ng/mL)
HENDERSON, Nev.--(BUSINESS WIRE)--
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 initiation of
patient enrollment in the second part of the Company's randomized Phase
2 clinical program of ozarelix, a luteinizing hormone-releasing hormone
(LHRH) antagonist, in men with prostate cancer for whom hormonal
treatment is indicated. The objective of the international,
multi-center, randomized, open-label study is to assess the safety and
efficacy of a monthly dosing regimen of ozarelix administered
subcutaneously (SC) versus ZOLADEX® (goserelin acetate) depot. The
Company will enroll an additional 150 patients in Part 2 of the clinical
program.
"We are pleased to announce the commencement of our Phase 2b ozarelix
study, which we believe increases the likelihood of demonstrating
clinically compelling activity while potentially avoiding limitations
associated with other endocrine therapies," stated Rajesh C. Shrotriya,
M.D., Chairman, President and Chief Executive Officer of Spectrum
Pharmaceuticals, Inc. "We believe this compound has great promise in
prostate cancer, the second leading cause of cancer death in men, for
which there continues to be a significant medical need for therapeutic
innovation. Based on the proven mechanism of action and encouraging
results from the first part of the clinical program, we are excited
about the potential of ozarelix."
Under the Phase 2b clinical protocol, patients will be randomized in a
2:1 ratio to either the ozarelix or goserelin arm, respectively.
Eligible patients randomized to the ozarelix arm will receive a loading
dose of SC ozarelix, followed by a lower maintenance dose on days 28 and
56. Eligible patients randomized to the goserelin arm will receive SC
goserelin at randomization followed by two doses of goserelin on days 28
and 56. All patients will be followed for 84 days. The primary outcome
will be to assess the percentage of patients who achieve the level of
testosterone < = 0.5 ng/mL from day 28 through day 84. Secondary outcomes
include: assessments of the percentage of patients with testosterone
surge ("hormone escape") during the first two weeks of treatment;
effects on Prostate Specific Antigen (PSA) levels; and safety of
ozarelix SC monthly dosing compared to goserelin depot SC monthly dosing.
The Phase 2b study is being conducted at multiple sites in the United
States, as well as in India through Spectrum's subsidiary, OncoRx.
About Prostate Cancer
Prostate cancer accounts for 10-30% of tumors in men and for 13% of male
cancer deaths, with peak incidence and peak mortality around 70 years of
age. After lung cancer, prostate cancer is the second most common cause
of cancer-related death in men. The global prostate cancer market is
expected to reach approximately $4.8 billion by 2015. For those patients
with prostate cancer who will require permanent androgen deprivation
therapy but do not undergo surgical castration (orchiectomy),
alternative treatments include endocrine therapy with LHRH analogs
(frequently combined with antiandrogens); however, these agents often
have limitations, including initial testosterone surge which may
exacerbate disease. Newer gonadotropin-releasing hormone (GnRH)
antagonists, particularly, LHRH antagonists, have been developed to
avoid these limitations and for use as monotherapy to treat prostate
cancer.
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 currently markets two
oncology drugs ─ FUSILEV® (levoleucovorin) for Injection 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.® is a registered trademark of Spectrum
Pharmaceuticals, Inc. REDEFINING CANCER CARE™ and the Spectrum
Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals,
Inc.
© 2012 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
Spectrum Pharmaceuticals
Shiv Kapoor, 702-835-6300
Vice
President, Strategic Planning & Investor Relations
InvestorRelations@sppirx.com
Source: Spectrum Pharmaceuticals
News Provided by Acquire Media
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