Peregrine Pharmaceuticals Provides Update on the Internal Review of Its Phase II Second-Line Non-Small Cell Lung Cancer Trial
January 07 2013 - 8:30AM
Marketwired
Peregrine Pharmaceuticals, Inc.(NASDAQ: PPHM), a biopharmaceutical
company developing first-in-class monoclonal antibodies focused on
the treatment and diagnosis of cancer, today provided an update
from its internal review of discrepancies from its Phase II
randomized, double-blind placebo-controlled trial of bavituximab in
second-line non-small cell lung cancer (NSCLC) in 121 patients. The
review was prompted by the discovery of vial coding discrepancies
while preparing for an end of Phase II meeting with the FDA. The
internal review included a thorough operational review of multiple
third-party vendor operations at sites worldwide, testing of
investigational product used in the trial, additional patient
sample testing to determine drug levels and a review of
immunogenicity testing results from the trial. The results of the
extensive internal review indicate that discrepancies are isolated
to the placebo and 1 mg/kg treatment arms of the trial and that
there was no evidence of discrepancies in the 3 mg/kg treatment arm
of the trial.
"Our goal in undertaking such a comprehensive review was to
understand every aspect of this clinical trial," said Jeffrey L.
Masten, vice president, quality of Peregrine. "Due to the complex
nature of this trial, this was an enormous effort involving
multiple third-party vendors and thousands of product and patient
samples obtained from three different continents. Specifically, we
sought to determine the cause and the impact of any discrepancies
within the trial and to verify every step within the drug product
distribution process. We believe we have accomplished our goals in
obtaining a more thorough understanding of the trial and we are
very pleased with the outcome."
Based on the results of the internal review, Peregrine is taking
a very conservative approach toward analyzing the results from the
trial which included combining the placebo and 1mg/kg arms into one
treatment arm (control arm), and comparing those results to the
3mg/kg arm. This analysis indicates that the 3 mg/kg arm continues
to show favorable tumor response rates, progression-free survival
and overall survival (OS) over the new combined control arm.
Peregrine expects to announce more detailed results from the
analysis in the near term when it is completed.
"The results from this comprehensive review have provided a
better understanding of the outcome of this trial. We believe that
these results of our internal review and subsequent data analysis
support advancing bavituximab into Phase III development for the
treatment of second-line non-small cell lung cancer," said Joseph
S. Shan, vice president, clinical and regulatory affairs of
Peregrine. "We are now preparing for discussions with the FDA and
worldwide regulatory agencies."
"With the results of this review in hand, we are now in the
process of updating potential partners and moving the program
forward," said Steven W. King, president and chief executive
officer of Peregrine. "Looking ahead, we anticipate data from seven
ongoing bavituximab trials in different indications as well as
results from an imaging study based on the same novel target."
About Bavituximab Bavituximab is a
first-in-class phosphatidylserine (PS)-targeting monoclonal
antibody that represents a new approach to treating cancer.
Bavituximab is the lead drug candidate from the company's PS
technology platform and is currently being tested in eight clinical
trials, including three randomized Phase II trials in front-line
and second-line non-small cell lung cancer and front-line
pancreatic cancer, and five investigator-sponsored trials (ISTs) in
additional oncology indications. PS is a highly immunosuppressive
molecule usually located inside the membrane of healthy cells, but
"flips" and becomes exposed on the outside of cells that line tumor
blood vessels, creating a specific target for anti-cancer
treatments. PS-targeting antibodies target and bind to PS and block
this immunosuppressive signal, thereby enabling the immune system
to recognize and fight the tumor.
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 product
candidate bavituximab and novel brain cancer agent Cotara®.
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 outside 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 final OS data from the randomized,
double-blind, placebo-controlled Phase IIb trial may be less
compelling than the data as presently calculated thereby creating
uncertainty with respect to the future development in second-line
NSCLC, the risks that partnering discussions may not result in a
partnering transaction or that such discussions could be hindered
or delayed as a result of the existing class action lawsuits, the
risk that results from the front-line NSCLC trail will not be
consistent with results experienced in earlier trials and may not
support advancing this indication into later stage trials. 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 the our SEC reports including,
but not limited to, the annual report on Form 10-K for the fiscal
year ended April 30, 2012 and quarterly report on Form 10-Q for the
quarter ended October 31, 2012. 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. Our business
could be affected by a number of other factors, including the risk
factors listed from time to time in the our SEC reports including,
but not limited to, the annual report on Form 10-K for the fiscal
year ended April 30, 2012 and quarterly report on Form 10-Q for the
quarter ended October 31, 2012. 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 or Jay Carlson Peregrine
Pharmaceuticals, Inc. (800) 987-8256 info@peregrineinc.com
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