Peregrine Pharmaceuticals Announces Initiation of an
Investigator-Sponsored Trial Combining Its Immunotherapy
Bavituximab and Ipilimumab (Yervoy(R)) in Advanced Melanoma
Randomized Trial to Evaluate Immune Activation Following
Treatment With Immunotherapy Combination; Open Label Design Will
Allow for Ongoing Evaluation of Clinical Results From Study
TUSTIN, CA--(Marketwired - Apr 23, 2014) - Peregrine
Pharmaceuticals, Inc. (NASDAQ: PPHM) (NASDAQ: PPHMP) today
announced the opening of an investigator-sponsored trial (IST) of
its investigational immunotherapy bavituximab in combination with
Bristol-Myers Squibb's ipilimumab (Yervoy®), for the treatment of
advanced melanoma. Bavituximab is an upstream immune checkpoint
inhibitor that targets phosphatidylserine (PS), a highly
immunosuppressive molecule exposed on cells that line tumor blood
vessels and tumor cells. Preclinical data in a model of melanoma
demonstrate that the combination of a bavituximab equivalent and
ipilimumab yield enhanced anti-tumor activity compared to
ipilimumab alone. The trial is being conducted at the University of
Texas Southwestern Medical Center, Dallas, and led by Arthur
E. Frankel, M.D., Associate Professor of Internal Medicine at the
Simmons Comprehensive Cancer Center. Bavituximab, Peregrine's lead
immuno-oncology candidate, is being evaluated in second-line
non-small cell lung cancer (NSCLC), as part of the SUNRISE pivotal
Phase III clinical trial.
"We are pleased that this leading melanoma specialist is
advancing this program into clinical development, recognizing that
there are patients who may not respond to the current standard of
care and that the combination of ipilimumab and bavituximab could
potentially elicit anti-tumor immune responses in a larger
proportion of patients," said Joseph Shan, MPH, vice president of
clinical and regulatory affairs at Peregrine. "We are particularly
excited as this trial is designed to provide proof-of-concept data
for this potentially innovative upstream and downstream checkpoint
inhibitor combination. In addition, the trial's open-label design
allows for the potential for data readouts throughout the course of
the trial."
This is an open label, two-arm, randomized, single-center Phase
Ib trial of bavituximab plus ipilimumab (Yervoy®), in patients with
advanced melanoma. Up to 24 patients will be randomized into the
following two treatment groups:
- Group A will enroll up to 16 patients to receive 2 weekly doses
of bavituximab (3mg/kg) followed by combination therapy of
ipilimumab (up to four cycles at 3mg/kg every 3 weeks) plus
bavituximab (3mg/kg weekly for 12 weeks)
- Group B will enroll up to 8 patients to receive standard
ipilimumab alone (up to four cycles at 3mg/kg every 3 weeks)
The primary endpoint of the trial will be safety and secondary
endpoints will include measurements of disease control rate (DCR)
and overall survival (OS). In addition, tumor biopsies will be
collected at screening to measure changes in myeloid-derived
suppressor cells (MDSC), tumor-associated macrophages (TAM),
T-regulatory cells (Treg) and peripheral blood cytokines. For more
information on this trial please visit ClinicalTrials.gov using the
identifier NCT01984255.
Preclinical Combination Data of PS-Targeting Antibody and
Anti-CTLA-4 Antibody
Preclinical data have shown that phosphatidylserine
(PS)-targeting antibodies reactivate tumor immunity at multiple
levels and that the combination of a PS-targeting antibody
equivalent to bavituximab and an anti-CTLA-4 antibody, an
FDA-approved immunotherapy, resulted in superior tumor growth
inhibition than with either antibody alone, with no additional
toxicity following multiple treatment doses. In addition,
histopathological analysis showed the combination produced more
inflammatory cell infiltration and tumor destruction than
anti-CTLA-4 alone.
About Melanoma
Melanoma is an aggressive and serious form of skin cancer that
while generally considered to be preventable and treatable upon
early detection, can be fatal if not diagnosed.1,2 Advanced
melanoma occurs when the cancer cells spread through the lymph
nodes to other parts of the body. By 2019, worldwide cases of
melanoma are expected to double to more than 227,000 from current
levels.3 According to the National Cancer Institute; in 2013 more
than 76,000 new cases of melanoma were diagnosed in the United
States.4
About Bavituximab: A Targeted Immunotherapy
Bavituximab is a first-in-class phosphatidylserine
(PS)-targeting monoclonal antibody that represents a new approach
to treating cancer. 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. These data, detailing the
immune-stimulatory mechanism of action of PS-targeting antibodies,
such as the company's lead drug candidate bavituximab, are the
subject of a manuscript published in the October 2013 issue of the
American Association for Cancer Research (AACR) peer-reviewed
journal, Cancer Immunology Research. As part of the
SUNRISE trial, bavituximab is being evaluated in a Phase III,
global, randomized, double-blind, placebo-controlled clinical trial
designed to evaluate the safety, tolerability and efficacy of
bavituximab plus docetaxel as second-line treatment in patients
with non-small cell lung cancer. Bavituximab is also currently
being evaluated in several solid tumor indications, including
breast cancer, liver cancer and rectal cancer. For additional
information about the SUNRISE trial please visit
www.SunriseTrial.com or ClinicalTrials.gov using Identifier
NCT01999673.
About SUNRISE Trial:
SUNRISE is a pivotal Phase III, randomized, placebo-controlled,
double-blind, multinational clinical trial evaluating the efficacy
and safety of bavituximab (bav i tux' i mab), a novel
investigational immunotherapy, plus docetaxel versus placebo plus
docetaxel as a second-line treatment for patients with Stage
IIIb/IV non-squamous non-small cell lung cancer (NSCLC). For more
information about the SUNRISE trial, please visit:
www.SunriseTrial.com
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 is developing
multiple clinical programs in cancer with its lead immunotherapy
candidate bavituximab, while seeking a partner to further advance
its 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
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 results from the Phase Ib trial of
bavituximab plus ipilimumab (Yervoy®) in patients with advanced
melanoma may not correlate with the data from the preclinical
studies. 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 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.
Yervoy is a registered trademark of Bristol-Meyers Squibb.
1. Leong, S.P. Future perspectives on malignant melanoma.
Surg Clin North Am 83, 453-456, x (2003).
2. Creagan ET. Malignant melanoma: an emerging and preventable
medical catastrophe. Mayo Clin Proc 1997;72(6):570-4.
3. Data Monitor Report. Melanoma cases to double. Press release.
Available from http://about.datamonitor.com/media/archives/4380
(Accessed March 2014) (2010).
4. National Cancer Institute.
http://www.cancer.gov/cancertopics/types/melanoma (Accessed March
2014).
Contact: Christopher Keenan or Jay Carlson Peregrine
Pharmaceuticals (800) 987-8256
info@peregrineinc.com
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