Peregrine Pharmaceuticals Provides Update on Oral Presentation of Top-Line Data from Phase III SUNRISE Trial of Bavituximab a...
September 21 2016 - 8:05AM
Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) (NASDAQ:PPHMP), a
biopharmaceutical company committed to improving patient lives by
manufacturing high quality products for biotechnology and
pharmaceutical companies and advancing its proprietary R&D
pipeline, today announced that top-line data from the Phase III
SUNRISE trial of bavituximab in patients with previously treated
locally advanced or metastatic non-squamous non-small cell lung
cancer (NSCLC) will be presented as a late-breaking oral
presentation at the upcoming European Society for Medical Oncology
(ESMO) 2016 Congress. Presented data will include a biomarker
in the SUNRISE trial that correlated with a statistically
significant improvement in overall survival for patients treated
with bavituximab in combination with docetaxel compared to patients
treated with docetaxel alone. Peregrine will file a new
patent application directed to the use of the biomarker prior to
the presentation of results at the ESMO 2016 Congress, which is
being held October 7-11, 2016 in Copenhagen, Denmark.
Details of the Phase III SUNRISE trial data
presentation are as follows:
Presentation Number: |
|
|
LBA45 |
Presentation Title: |
|
|
Top-line
results from SUNRISE: A Phase III Randomized Double-Blind,
Placebo-Controlled Multicenter Trial of Bavituximab Plus Docetaxel
in Patients with Previously Treated Stage IIIb/IV Non-Squamous
Non-Small Cell Lung Cancer |
Date: |
|
|
Monday,
October 10, 2016 |
Time: |
|
|
9:15
a.m. (local time in Copenhagen) |
"I want to start by thanking the patients,
investigators and scientists involved in the SUNRISE trial that
have made possible the continuing collection and analysis of
important data from the study. While the current interim
analysis is still ongoing, it is exciting to already see that a
biomarker associated with positive outcomes for patients receiving
the combination of bavituximab with docetaxel has been
identified. In the evolving cancer therapeutic space,
biomarker identification is playing an increasingly critical role
in guiding clinical development strategies and trial designs,” said
Steven W. King, president and chief executive officer of
Peregrine. “It is important to note that we are undertaking a
broad biomarker analysis effort as part of the SUNRISE trial and
this initial set of data is just the first of what we hope will be
several findings that will help guide the bavituximab clinical
program going forward. We look forward to presenting results from
this ongoing analysis effort at the ESMO 2016 Congress, as well as
other medical conferences as the additional data becomes
available.”
The primary goal of the biomarker analysis is to
identify a biomarker profile for patients that receive the most
benefit from a bavituximab-containing therapeutic regimen. As
specified in the study protocol, thousands of patient samples were
collected to potentially identify biomarkers associated with
improved outcome for patients receiving bavituximab. Peregrine is
in the process of filing a new patent application directed to the
use of the initial biomarker discovery which will be presented at
the ESMO 2016 Congress. Additional patient sample testing and
analysis is ongoing and may result in other biomarkers of
importance.
Bavituximab is an investigational chimeric
monoclonal antibody that targets phosphatidylserine (PS). Signals
from PS inhibit the ability of immune cells to recognize and fight
tumors. Bavituximab is believed to override PS mediated
immunosuppressive signaling by blocking the engagement of PS with
its receptors as well as by sending an alternate immune activating
signal. PS targeting antibodies have been shown to shift the
functions of immune cells in tumors, resulting in multiple signs of
immune activation and anti-tumor immune responses.
Peregrine’s clinical development strategy for
bavituximab is currently focused on small, early-stage
proof-of-concept trials evaluating the drug in combination with
other cancer treatments. The intent behind this strategy is
to control research and development costs, while continuing to
generate clinical data to further validate bavituximab's
combination potential that will be critical to bringing onboard a
partner to help advance the program.
About Peregrine Pharmaceuticals,
Inc.Peregrine Pharmaceuticals, Inc. is a biopharmaceutical
company committed to improving the lives of patients by delivering
high quality pharmaceutical products through its contract
development and manufacturing organization (CDMO) services and
through advancing and licensing its investigational immunotherapy
and related products. Peregrine's in-house CDMO services,
including cGMP manufacturing and development capabilities, are
provided through its wholly-owned subsidiary Avid Bioservices, Inc.
(www.avidbio.com), which provides development and biomanufacturing
services for both Peregrine and third-party customers. The
company is also working to evaluate its lead immunotherapy
candidate, bavituximab, in combination with immune stimulating
therapies for the treatment of various cancers, and developing its
proprietary exosome technology for the detection and monitoring of
cancer. For more information, please visit
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 the
final data from the biomarker analysis does not identify any
biomarker associated with improved outcome for patients receiving
bavituximab or generate any partnership interest, the risk that
on-going analysis of SUNRISE trial data, bio-specimen samples and
patient characteristics may not identify any subgroup that received
clinical benefit from the addition of bavituximab and the risk that
the company is unable to secure patent protection or other
intellectual property protection for the biomarker analyses.
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, 2016 as well as any
updates to these risk factors filed from time to time in the
company's other filings with the Securities and Exchange
Commission. 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.
Contacts:
Stephanie Diaz (Investors)
Vida Strategic Partners
415-675-7401
sdiaz@vidasp.com
Tim Brons (Media)
Vida Strategic Partners
415-675-7402
tbrons@vidasp.com
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