Peregrine
Pharmaceuticals PPHM, today announced the opening to
enrollment of its SUNRISE trial at leading oncology centers in the
United States. SUNRISE is a pivotal Phase III clinical trial
comparing the company's investigational immunotherapy bavituximab
plus the chemotherapy docetaxel against placebo plus the chemotherapy
docetaxel in patients with second-line non-small cell lung cancer
(NSCLC). This trial will enroll approximately 600patients from more
than 100 medical centers worldwide.
"The design of the SUNRISE trial was based on the compelling Phase II
data demonstrating encouraging improvement in overall survival in
patients with second-line NSCLC. Furthermore, peer-reviewed published
data support that bavituximab and docetaxel share highly compatible
mechanisms of action that we believe hold promise for improved
patient outcomes,"(1-6) said Joe Shan, MPH, vice president of
clinical and regulatory affairs at Peregrine. "We believe harnessing
the body's natural immune system to fight cancer will be an integral
part to conquering this deadly disease. Multiple peer-reviewed
published data support bavituximab's immunotherapy mechanism of
action whereby the targeted monoclonal antibody blocks an immune
checkpoint responsible for immune suppression at the local tumor
environment, thereby allowing the immune system to recognize and
fight this deadly disease."
"This is a significant milestone for the company as patients with
advanced non-small cell lung cancer who have progressed on a prior
treatment have few therapeutic options, and new approaches to
managing their disease are in demand," said Steven King, chief
executive officer of Peregrine. "As part of our plan to provide
patient and physicians with the necessary information regarding this
trial, today we launched the SunriseTrial.com web portal to serve as
a gateway for trial parameters and additional resources. We
anticipate that in executing our global plan we can enroll the
majority of patients in this trial from the United States and Western
Europe."
SUNRISE ("Stimulating ImmUne RespoNse thRough BavItuximab in a PhaSE
III Lung Cancer Study") is a Phase III, global, randomized,
double-blind, placebo-controlled clinical trial designed to evaluate
the safety, tolerability and efficacy of bavituximab plus docetaxel
in patients with second-line NSCLC. The trial will evaluate
bavituximab plus docetaxel versus docetaxel plus placebo in
approximately 600 patientsat clinical sites worldwide. Patients with
Stage IIIb/IV non-squamous, NSCLC who have progressed after standard
front-line treatment are eligible for enrollment. Patients will be
randomized into 1 of 2 treatment arms. All patients will receive up
to six 21-day cycles of docetaxel (75 mg/m2) plus weekly infusions of
either bavituximab (3mg/kg) or placebo until progression of toxicity.
The primary endpoint of the trial will be overall survival. For
additional information about the SUNRISE trial please visit
www.SunriseTrial.com or ClinicalTrials.gov using Identifier
NCT01999673.
About Peregrine Pharmaceuticals, Inc.
Peregrine Pharmaceuticals,
Inc. is a biopharmaceutical company with a portfolio of innovative
monoclonal antibodies in clinical trials focused on the treatment and
diagnosis of cancer. The company is pursuing multiple clinical
programs in cancer with its lead immunotherapy candidate bavituximab
while seeking a partner to further advance its novel brain cancer
agent Cotara(R). Peregrine also has in-house cGMP manufacturing
capabilities through its wholly-owned subsidiary Avid Bioservices,
Inc. (www.avidbio.com), which provides development and
biomanufacturing services for both Peregrine and third-party
customers. Additional information about Peregrine can be found at
www.peregrineinc.com.
Safe Harbor Statement: Statements in this press release which are not
purely historical, including statements regarding Peregrine
Pharmaceuticals' intentions, hopes, beliefs, expectations,
representations, projections, plans or predictions of the future are
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. The forward-looking
statements involve risks and uncertainties including, but not limited
to, the risk that enrollment of the Phase III trial may experience
delays or take longer than anticipated, the risk that the results
from the Phase III trial may not support a future Biologics License
Application (BLA) submission, the risk that the company may not have
or raise adequate financial resources to complete the Phase III trial
and the risk that the company may not find a suitable partner for the
Phase III trial or the PS program. It is important to note that the
company's actual results could differ materially from those in any
such forward-looking statements. Factors that could cause actual
results to differ materially include, but are not limited to,
uncertainties associated with completing preclinical and clinical
trials for our technologies; the early stage of product development;
the significant costs to develop our products as all of our products
are currently in development, preclinical studies or clinical trials;
obtaining additional financing to support our operations and the
development of our products; obtaining regulatory approval for our
technologies; anticipated timing of regulatory filings and the
potential success in gaining regulatory approval and complying with
governmental regulations applicable to our business. Our business
could be affected by a number of other factors, including the risk
factors listed from time to time in our reports filed with the
Securities and Exchange Commission including, but not limited to, our
annual report on Form 10-K for the fiscal year ended April 30, 2013
and quarterly report on Form 10-Q for the quarter ended October 31,
2013. The company cautions investors not to place undue reliance on
the forward-looking statements contained in this press release.
Peregrine Pharmaceuticals, Inc. disclaims any obligation, and does
not undertake to update or revise any forward-looking statements in
this press release.
References
1. Yin et al. Phosphatidylserine-Targeting Antibody Induces M1
Macrophage Polarization and Promotes Myeloid-Derived Suppressor Cell
Differentiation, Cancer Immunology Research. 2013 Oct 1 (4):256-68.
2. Fabbri et al. Sequential events of apoptosis involving docetaxel,
a microtubule-interfering agent: a cytometric study. BMC Cell Biol.
2006 Jan 26;7:6.
3. Gong et al. Measuring response to therapy by near-infrared imaging
of tumors using a phosphatidylserine-targeting antibody fragment. Mol
Imaging. 2013 Jun 1;12(4):244-56.
4. Huang et al. A monoclonal antibody that binds anionic
phospholipids on tumor blood vessels enhances the antitumor effect of
docetaxel on human breast tumors in mice. Cancer Res. 2005 May
15;65(10):4408-16.
5. Kodumudi et al. A Novel Chemoimmunomodulating Property of
Docetaxel: Suppression of Myeloid-Derived Suppressor Cells in Tumor
Bearers. Clin Cancer Res 2010;16:4583-94.
6. Hodge et al. Chemotherapy-induced immunogenic modulation of tumor
cells enhances killing by cytotoxic T lymphocytes and is distinct
from immunogenic cell death. Int. J. Cancer: 2013; 133(3):624-36.
Market News and Data brought to you by Benzinga APIs© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Loading...
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in