Data Presented at AACR Support Potential of Combining Peregrine's PS-Targeting Immunotherapy Agent Bavituximab With Irradiati...
April 07 2014 - 8:00AM
Marketwired
Data Presented at AACR Support Potential of Combining Peregrine's
PS-Targeting Immunotherapy Agent Bavituximab With Irradiation in
Lung Cancer
Combination of PS-Targeting Antibody and Radiation Resulted in
100% Survival at 6 Months Compared to 43% With Irradiation Alone in
Preclinical Lung Cancer Model
TUSTIN, CA--(Marketwired - Apr 7, 2014) - Peregrine
Pharmaceuticals, Inc. (NASDAQ: PPHM) (NASDAQ: PPHMP), a
biopharmaceutical company developing first-in-class monoclonal
antibodies focused on the treatment and diagnosis of cancer, today
announced data from studies demonstrating that an equivalent
antibody to Peregrine's lead immunotherapeutic antibody candidate
bavituximab administered with stereotactic body radiation therapy
(SBRT) showed a 100% improvement in survival and favorable tumor
eradication in a model of non-small cell lung cancer (NSCLC)
compared to irradiation alone. These data were presented yesterday
at the 105th Annual Meeting of the American Association for Cancer
Research (AACR) being held in San Diego, California from April 5-9,
2014. Bavituximab is an investigational immunotherapy currently
being evaluated in NSCLC as part of the SUNRISE pivotal Phase III
clinical trial.
"Data from these studies show a very impressive survival
improvement and tumor burden reduction when administering an animal
equivalent of bavituximab with radiation therapy compared to
radiation alone," said Jeff T. Hutchins, Ph.D., vice president of
preclinical research at Peregrine. "Importantly, the use of lower
doses of stereotactic body radiation, a highly targeted therapeutic
irradiation technique, demonstrates considerable therapeutic value
in combination with bavituximab activity. Based on these results,
we believe there is potential for more effective and less toxic
combinations of stereotactic body radiation and investigational
immunotherapies like bavituximab to work together as a potential
treatment modality for patients with lung cancer."
These studies utilized rats bearing established orthotopic
A549-luc NSCLC tumors, which were staged and monitored by
bioluminescence imaging. Animals were treated with 3x12 Gy of
radiation alone or combined with 2aG4 (mouse equivalent antibody to
bavituximab) injected twice weekly. Rats treated with
radiation and 2aG4 had a 100% survival rate 184 days after
implantation and tumors were completely eradicated in 67% of these
animals. In contrast, rats treated with radiation had a
survival rate of 43% while only 12.5% of untreated rats survived. A
toxicity study was conducted in which 3x12 Gy of radiation was
delivered to central organs of tumor-free rats. This treatment
does not appear to cause severe toxicity. These results
suggest that bavituximab with radiation may result in improved
clinical outcome in patients with centrally-located NSCLC. This
research was conducted under grant RP120670-P4 by the Cancer
Prevention Research Institute of Texas (CPRIT) awarded to The
University of Texas Southwestern Medical Center.
Abstract Details: Abstract Number: 639 Presentation Title:
Antibody-mediated blockade of phosphatidylserine combined with
radiation improves survival and tumor eradication in a rat model of
non-small cell lung cancer Presentation Time: Sunday, Apr 06, 2014,
1:00 PM - 5:00 PM Location: Hall A-E, Poster Section 27 Poster
Board Number: 14 Author Block: Olivier Belzile, Zhang Zhang,
Xianming Huang, Debabrata Saha, Rolf A. Brekken. University of
Texas Southwestern Medical Center, Dallas, Texas
A copy of this poster is available in the Technology section of
Peregrine's website located at
http://www.peregrineinc.com/technology/bavituximab-oncology/recent-data.html.
About Bavituximab: A Targeted Investigational 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 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 results from human clinical studies
involving combinations of bavituximab with irradiation 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 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.
Contact: Christopher Keenan or Jay Carlson Peregrine
Pharmaceuticals (800) 987-8256
info@peregrineinc.com
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