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 dosing of the first patient in a Phase II
clinical trial evaluating the combination of bavituximab,
temozolomide, and radiation therapy in patients with newly
diagnosed glioblastoma. Elizabeth R. Gerstner, MD, at Massachusetts
General Hospital Cancer Center, is the primary investigator for the
trial, which is one of three bavituximab clinical studies being
funded by the National Comprehensive Cancer Network® (NCCN®)
Oncology Research Program (ORP) through a grant provided by
Peregrine.
The single group, interventional Phase II trial
will enroll approximately 36 patients with newly diagnosed
glioblastoma. Patients will receive standard of care
radiation, as well as daily temozolomide treatment and weekly
bavituximab treatment, throughout the 18-week study. The
primary objective of the trial is overall survival at twelve
months. Secondary outcome measures include progression free
survival (PFS) and radiographic response.
“We are hopeful that results from this trial, as
well as from the two additional studies at NCCN Member
Institutions, will continue to support our belief that bavituximab
works to create a more immune active tumor microenvironment in
which other therapies are able to have a greater anti-tumor
effect,” said Joseph Shan, MPH, vice president, clinical and
regulatory affairs of Peregrine. “We look forward to following this
important study at the Massachusetts General Hospital Cancer
Center, as well as the planned trials at the Moffitt Cancer Center
and The Sidney Kimmel Comprehensive Cancer Center at Johns
Hopkins.”
Results from a previous preclinical study
highlighted that PS-targeting antibodies similar to bavituximab
synergize with radiation to improve anti-tumor activity in the F98
rat model of glioblastoma. These study data, generated by
researchers at the University of Texas, Southwestern, demonstrated
that PS-targeting treatment in combination with radiation more than
doubled the median survival time of glioma-bearing rats and was
significantly superior to either PS-targeting or radiation alone (p
< 0.001). Additionally, 13% of the glioma-bearing rats
treated with the combination were rendered disease free. These
disease-free animals were immune to a rechallenge with F98 glioma
cells, suggesting that the combination treatment had induced an
adaptive immunity to the tumor cells.
NCCN, a not-for-profit alliance of 27 leading
cancer centers devoted to patient care, research, and education, is
dedicated to improving the quality, effectiveness, and efficiency
of cancer care so that patients can live better lives.
Funding for the three investigator-initiated clinical studies has
been provided by Peregrine in the form of a research grant to NCCN
ORP. NCCN is responsible for oversight and monitoring of the
clinical studies through the research grant.
Details of the two additional NCCN-supported studies are as
follows:
- A Phase I Trial of Sorafenib and Bavituximab Plus Stereotactic
Body Radiation Therapy (SBRT) for 1st Line Treatment of
Unresectable Hepatocellular Carcinoma; Jessica Frakes, MD, Moffitt
Cancer
Center.
- Phase II Study of Pembrolizumab and Bavituximab for Progressive
Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck;
Ranee Mehra, MD, The Sidney Kimmel Comprehensive Cancer Center at
Johns Hopkins.
Bavituximab is an investigational
immune-modulatory monoclonal antibody that targets
phosphatidylserine (PS), a phospholipid that inhibits the ability
of immune cells to recognize and fight tumors. Bavituximab is
believed to reverse PS-mediated immunosuppression 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. This mechanism may play an important role
in allowing other cancer therapies to more effectively attack
tumors by reversing the immunosuppression that limits the impact of
those treatments.
Importantly, bavituximab has also demonstrated a
favorable safety and tolerability profile across several clinical
trials conducted to date, which may offer the compound a key
advantage as the evolving cancer treatment landscape continues to
shift to a combination therapy approach. The ability to be
added to a range of other cancer therapies without causing added
safety concerns may position bavituximab favorably as a component
of combination treatments.
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.
About the National Comprehensive Cancer
NetworkThe National Comprehensive Cancer Network® (NCCN®),
a not-for-profit alliance of 27 leading cancer centers devoted to
patient care, research, and education, is dedicated to improving
the quality, effectiveness, and efficiency of cancer care so that
patients can live better lives. Through the leadership and
expertise of clinical professionals at NCCN Member Institutions,
NCCN develops resources that present valuable information to the
numerous stakeholders in the health care delivery system. As the
arbiter of high-quality cancer care, NCCN promotes the importance
of continuous quality improvement and recognizes the significance
of creating clinical practice guidelines appropriate for use by
patients, clinicians, and other health care decision-makers.
The NCCN Member Institutions are: Fred &
Pamela Buffett Cancer Center, Omaha, NE; Case Comprehensive Cancer
Center/University Hospitals Seidman Cancer Center and Cleveland
Clinic Taussig Cancer Institute, Cleveland, OH; City of Hope
Comprehensive Cancer Center, Los Angeles, CA; Dana-Farber/Brigham
and Women’s Cancer Center | Massachusetts General Hospital Cancer
Center, Boston, MA; Duke Cancer Institute, Durham, NC; Fox Chase
Cancer Center, Philadelphia, PA; Huntsman Cancer Institute at the
University of Utah, Salt Lake City, UT; Fred Hutchinson Cancer
Research Center/Seattle Cancer Care Alliance, Seattle, WA; The
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins,
Baltimore, MD; Robert H. Lurie Comprehensive Cancer Center of
Northwestern University, Chicago, IL; Mayo Clinic Cancer Center,
Phoenix/Scottsdale, AZ, Jacksonville, FL, and Rochester, MN;
Memorial Sloan Kettering Cancer Center, New York, NY; Moffitt
Cancer Center, Tampa, FL; The Ohio State University Comprehensive
Cancer Center - James Cancer Hospital and Solove Research
Institute, Columbus, OH; Roswell Park Cancer Institute, Buffalo,
NY; Siteman Cancer Center at Barnes-Jewish Hospital and Washington
University School of Medicine, St. Louis, MO; St. Jude Children’s
Research Hospital/The University of Tennessee Health Science
Center, Memphis, TN; Stanford Cancer Institute, Stanford, CA;
University of Alabama at Birmingham Comprehensive Cancer Center,
Birmingham, AL; UC San Diego Moores Cancer Center, La Jolla, CA;
UCSF Helen Diller Family Comprehensive Cancer Center, San
Francisco, CA; University of Colorado Cancer Center, Aurora, CO;
University of Michigan Comprehensive Cancer Center, Ann Arbor, MI;
The University of Texas MD Anderson Cancer Center, Houston, TX;
University of Wisconsin Carbone Cancer Center, Madison, WI;
Vanderbilt-Ingram Cancer Center, Nashville, TN; and Yale Cancer
Center/Smilow Cancer Hospital, New Haven, CT.
Clinicians, visit NCCN.org. Patients and
caregivers, visit NCCN.org/patients. Media, visit
NCCN.org/news.
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
results from this trial and/or from the two additional NCCN
studies, will not support our current belief that bavituximab works
to create a more immune active tumor microenvironment in which
other therapies are able to have a greater anti-tumor effect, the
risk that the initiation of one or both of the two additional NCCN
studies is delayed and the risk that the company may not be
able to partner the bavituximab program. 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, 2017 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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