Peregrine Pharmaceuticals Announces Promising Bavituximab Phase I Data Published in the Peer-Reviewed Journal Cancer Medicine...
March 31 2015 - 12:45PM
- Combination of Bavituximab and Paclitaxel
Achieved an 85% Objective Response-
- Design of Phase II Clinical Trial Underway
-
Peregrine Pharmaceuticals (Nasdaq:PPHM) (Nasdaq:PPHMP), today
announced the peer-reviewed publication of clinical data from a
Phase I investigator-sponsored trial evaluating the company's lead
investigational immunotherapy bavituximab plus paclitaxel therapy
in patients with HER2-negative metastatic breast cancer. The
manuscript details the results of the Phase I trial showing that
the combination produced an objective tumor response in 85% of
patients, including 15% of these patients achieving a complete
response, measured in accordance with Response Evaluation Criteria
In Solid Tumors (RECIST) criteria.
"The publication of these data marks an important milestone in
the development of this novel therapeutic in a difficult to treat
patient population," said Alison Stopeck, M.D., the principal
investigator on the trial and Professor, Department of Medicine and
Associate Director for Translational Research at the Stony Brook
Cancer Center in Stony Brook, New York. "The regimen was very well
tolerated and the clinical responses were encouraging. The data
also suggest bavituximab may uniquely affect the coagulation system
in a beneficial way for cancer patients. It is my belief that the
combination of bavituximab with weekly paclitaxel is a feasible
regimen that is associated with a promising response rate in
patients with metastatic breast cancer and warrants further
clinical exploration."
In the online released manuscript, researchers at the University
of Arizona Medical Center led by Alison Stopeck, M.D. enrolled 14
patients with metastatic breast cancer (MBC) and while all were
evaluable for toxicity, 13 were evaluable for response and
progression free survival (PFS). These patients with HER2-negative
MBC were treated with paclitaxel (80 mg/m2) weekly for three weeks
of each four-week cycle and bavituximab (3 mg/kg) administered
weekly beginning on day 15 after two weekly doses of paclitaxel.
Results from 13 evaluable patients showed that 11 patients (85%)
achieved an objective response, including two patients (15%) that
achieved a complete response (CR), 9 patients with partial
responses (PR) and 2 patients with progressive disease (PD). Median
PFS for the combination of bavituximab with weekly paclitaxel was
7.3 months. In addition, the combination of bavituximab and
paclitaxel was safe and well-tolerated with the majority of grade 1
or 2 adverse events being paclitaxel related. Approximately half of
these patients were classified as "triple negative," a
traditionally difficult-to-treat patient population. In addition,
treatment with bavituximab reduced circulating PS-expressing
microparticles (exosomes) which are immunosuppressive.
"These compelling results in a very difficult to treat patient
population provide the foundation to move with confidence into a
later stage trial," said Joseph Shan, vice president of clinical
and regulatory affairs at Peregrine Pharmaceuticals. "These data
build upon our historical clinical experience in the area of breast
cancer and when combined with recent preclinical data demonstrating
bavituximab's ability to promote antitumor immune activity,
increase our understanding of the immune-stimulatory aspects of
bavituximab."
These results appear in the March issue of the peer-reviewed
journal, Cancer Medicine, in a manuscript titled: "A Phase I
Clinical Trial of Bavituximab and Paclitaxel in Patients with HER-2
Negative Metastatic Breast Cancer."
The online article is available at:
http://onlinelibrary.wiley.com/doi/10.1002/cam4.447/full
About Peregrine Pharmaceuticals, Inc.
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company
with a pipeline of novel drug candidates in clinical trials for the
treatment and diagnosis of cancer. The company's lead immunotherapy
candidate, bavituximab is in Phase III development for the
treatment of second-line non-small lung cancer (the "SUNRISE
trial") along with several investigator-sponsored trials evaluating
other treatment combinations and additional oncology indications.
The company is also advancing a molecular imaging agent,
124I-PGN650, in an exploratory clinical trial for the imaging of
multiple solid tumor types. 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 the company may not have or raise
adequate financial resources to initiate a later stage breast
cancer clinical trial and the risk that the results of a later
stage breast cancer clinical trial will not be consistent with the
results from this Phase I breast cancer trial. 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, 2014 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.
CONTACT: Christopher Keenan
Peregrine Pharmaceuticals, Inc.
(800) 987-8256
info@peregrineinc.com
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