Presentation at Annual Society of Surgical Oncology Meeting Updates Progress in Investigator-Sponsored Phase i/ii Trial of Pe...
March 14 2014 - 8:00AM
Marketwired
Presentation at Annual Society of Surgical Oncology Meeting Updates
Progress in Investigator-Sponsored Phase i/ii Trial of Peregrine's
Bavituximab in Combination With Sorafenib in Liver Cancer
Results Support Potential of Bavituximab in Combination With
Sorafenib; Investigator is Encouraged by Promising Results as Phase
II Enrollment Nears Completion
TUSTIN, CA--(Marketwired - Mar 14, 2014) - Peregrine
Pharmaceuticals, Inc. (NASDAQ: PPHM) (NASDAQ: PPHMP), today
announced the presentation of an update to the ongoing
Investigator-Sponsored Trial (IST) of its immunotherapy bavituximab
in combination with the chemotherapy sorafenib (Nexavar®) in
patients with advanced hepatocellular carcinoma (HCC) or liver
cancer. The oral presentation was given at the 67th
Society of Surgical Oncology (SSO) Annual Cancer Symposium being
held March 12-15, 2014 at the Phoenix Convention Center in Phoenix,
Arizona.
In a presentation titled: "Combination of Bavituximab and
Sorafenib Inhibits HCC Growth: Results of Preclinical Data and a
Phase I Study" Dr. Adam Yopp, Assistant Professor of Surgery
at the University of Texas Southwestern Medical Center, Dallas,
Texas provided an overview of the preclinical data and the ongoing
Phase I/II trial.
"The Phase II portion of this trial is ongoing with 34 of the 38
intended patients currently enrolled, 10 of which are currently on
treatment with the longest one on treatment for 18 months," said
Dr. Yopp. "This open-labeled trial is almost complete and while the
results are preliminary, they are promising. I am excited about
this potential combination given the new understandings about
bavituximab's mechanism and I look forward to sharing the full set
of data from this Phase II trial later this year."
In his presentation, Dr. Yopp reviewed preclinical data
demonstrating that sorafenib induces PS exposure on endothelial
cells in vitro and in vivo and that antibody-mediated PS blockade
revitalizes the immune response in murine HCC xenografts and
enhances the activity of sorafenib. Researchers determined that the
combination of bavituximab and sorafenib is superior to sorafenib
alone at treating C3A HCC in mice.
Dr. Yopp then reviewed results from the Phase I portion of this
Phase I/II trial which enrolled 10 patients with advanced liver
cancer. Results demonstrated that the combination of bavituximab
and sorafenib was well-tolerated with common toxicities at all
grades related to sorafenib and that no dose-limiting toxicities
were reached for bavituximab at any of the treatment levels (0.3,
1.0, and 3.0 mg/kg). This supported the progression into the Phase
II portion with the 3.0 mg/kg dose.
The Phase II portion of this trial is a single-center,
single-arm, non-randomized, open-label trial with the primary
endpoint of radiologic time to progression with imaging occurring
at 6 week intervals. Secondary endpoints of the trial include
overall survival (OS), progression free survival (PFS), safety and
response rates. The trial is scheduled to enroll 38 patients with
advanced liver cancer. In addition, in order to leverage recent
understandings surrounding the immune-stimulatory mechanism of
action of bavituximab, several additional components have been
installed into this portion of the trial. These include plasma and
serum collection and tissue biopsies for evaluating changes in
immune response following bavituximab treatment. Specifically, to
assess whether combination therapy reactivates tumor immunity by
changing the tumor microenvironment from immunosuppressive to
immunoreactive, changing the tumor infiltrating cell composition or
inducing T cell response to tumor antigens.
More information on this trial can be found at
ClinicalTrials.gov using the Identifier NCT01264705.
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.
Bavituximab is currently being evaluated in several solid tumor
indications, including non-small cell lung cancer, breast cancer,
liver cancer and rectal cancer with a trial in advanced melanoma
anticipated to initiate in the near future.
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 later stage clinical
trials may not correlate with the results from the phase I/II
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 SEC 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.
Nexavar® (sorafenib) is a registered trademark of Bayer
Pharmaceuticals.
Contact: Christopher Keenan or Jay Carlson Peregrine
Pharmaceuticals (800) 987-8256
info@peregrineinc.com
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