Every type of disease has a specific
treatment program. We have drugs to treat symptoms of countless illnesses and
maladies, but viral infections continue to elude treatment. While we have
vaccines to prevent initial infection of some viruses and other medications to
treat problematic symptoms, there is little one can do to prevent a virus from
replicating and causing disease. Viral infections can be lethal and without
treatment options, we are left with our own natural defenses to fight off viral
invaders. This is about to change.
Researchers at UT Southwestern Medical Center in collaboration with Peregrine
Pharmaceuticals have published a study in Nature Medicine
demonstrating the success of their broad anti-viral drug bavituximab to cure
lethal viral infections in animals.
Bavituximab represents a new class of medication. It is an
anti-phosphatidylserine (anti-PS) antibody platform, which acts on
phosphatidylserine (PS) molecules of infected cells, a new target treating
viral infections.
This study was based on an observation made by Dr. Philip Thorpe, a professor
of pharmacology at UT Southwestern and senior author of the study, who observed
that when cells become infected and overtaken by a virus, the PS molecules flip
their positions, hindering their normal signaling functions for cell repair or
recycling due to damage to the cell. The PS molecule is a part of the
phospholipid family which
form the membranes of our cells, consisting of a phospholipid attached
to an amino acid, serine. The amino acid is usual positioned on the
inside of the cell, but upon infection, flips to the outside. Exposed PS allows
viruses to evade the immune system, impairing normal immune function and
masking infection. This specific molecule and action therefore provides
a new target to rid the body of viruses.
As a result, his laboratory developed an anti-PS antibody, bavituximab,
which binds to the PS molecule on the outside of infected cells. With the
antibody bound to the outside of the cell as a marker, the immune system is
signaled to move in and destroy the cells before the virus has a chance to
replicate and spread to other parts of the body. By signaling the immune system
quickly, it can more effectively destroy and eliminate the viral infection.
Supporting Thorpe’s postulate, researchers have found that PS is exposed on the
outer membrane of cells infected with HIV, influenza, herpes simplex viruses,
hemorrhagic fever viruses, and measles as well as smallpox and rabies virus
families.
"When injected into the bloodstream, bavituximab circulates in the body
until it finds these inside-out lipids and then binds to them," said
Thorpe. "In the case of virus infection, the binding raises a red flag to
the body's immune system, forcing the deployment of defensive white blood cells
to attack the infected cells."
The study reported today, examined the activity of bavituximab in animal groups
exposed to two different lethal viruses, cytomegalovirus (CMV) and Lassa fever
virus, a hemorrhagic fever virus classified as a class A bioterrorism agent by
the CDC. The results showed significant anti-viral activity against both
groups. The first experiment saw groups of guinea pigs infected with a virus
similar to Lassa virus recover from the infection upon treatment with bavituximab.
50% of the treated group survived while the control group showed a 100%
mortality rate from the infection. The anti-PS also cured mice infected with
CMV, which is often found in those with suppressed immune systems such as in
AIDS or autoimmune disease patients. 100% if the mice infected with CMV and
treated with bavituximab recovered fully while only 25% of the control animals
survived the infection.
"Based on these findings, anti-PS antibodies such as bavituximab may
represent a completely new class of drugs for the treatment of life-threatening
viral infections," said Thorpe. "By targeting a property of the host
cell rather than the virus itself, anti-PS antibodies have the potential to
treat a range of viral infections, and they should be less susceptible to the
viral mutations that contribute to the development of drug resistance."
Viruses adapt quickly to both our immune system's defenses and anti-viral
drugs. Their mutation rate is extremely rapid as they search for vulnerability
and take forms not susceptible to treatment. By developing a treatment which
targets a host cellular response instead, the results are much less vulnerable
to viral mutation.
"Recent non-affiliated research has further confirmed that exposed PS has
immunosuppressive properties and is also clarifying its involvement during
viral infection of cells,” says Dr. Melina Soares, lead study author and UT
Southwestern instructor of pharmacology. “Our data go a step further, providing
compelling evidence that exposed PS itself is a promising anti-viral drug
target that is involved in the pathogenesis of multiple viruses, suggesting the
possibility of achieving broad-spectrum anti-viral effects using a single
anti-PS agent. We look forward to further exploring the potential of bavituximab
and other anti-PS antibodies against viruses for which there are few or no
effective therapeutic options."
Bavituximab is currently being studied in clinical trials for treatment against
hepatitis C virus (HCV) and in preclinical trials for treatment against HIV,
cytomegalovirus (CMV), viral hemorrhagic fever and other serious viral
infections. These results are of great interest to the US Defense Threat
Reduction Agency (DTRA) who funded Peregrine research of biodefense programs
worth up to $ 44.4 million for the development of bavituximab and similar
anti-viral agents.
"It could very well be that this is a generic feature of enveloped
viruses," says Soares. "It could lead to a new, broad spectrum
anti-viral treatment."
PS-Antibodies Do Double Duty:
Fight Viruses and Cancer
Peregrine's PS-targeting
antibodies highlighted in AACR Annual Meeting studies
Preclinical studies highlight the ability of
PS-targeting antibodies to reverse the immune suppressing effects of tumors by
changing the tumor microenvironment and mobilizing key components of the immune
system
DENVER, Colorado and TUSTIN, Calif.,
April 21, 2009--Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), a clinical
stage biopharmaceutical company developing monoclonal antibodies for the treatment
of cancer and serious virus infections, today reported that two preclinical
studies presented during the AACR 100th Annual Meeting 2009 provided further
confirmation of the immunomodulatory mechanisms contributing to the anti-tumor
activity of its phosphatidylserine (PS) targeting antibodies. One study
confirms the anti-tumor effects and immune stimulating ability of a fully human
anti-PS antibody and the other demonstrates the ability of a second fully human
anti-PS antibody to stimulate development of a critical component of the
adaptive immune system.
These human PS-targeting antibodies,
which are currently being evaluated for both anti-cancer and anti-viral
applications, increase the number of product candidates in Peregrine's anti-PS
pipeline. Peregrine's lead anti-PS antibody bavituximab is currently in Phase
II clinical trials in advanced breast and lung cancers.
"These preclinical studies
further elucidate the unique immunomodulatory mechanisms contributing to the
observed anti-tumor activity of anti-PS antibodies in preclinical and clinical
studies," said Dr. Philip Thorpe, professor of pharmacology at UT
Southwestern Medical Center in Dallas, a scientific advisor to Peregrine and
co-author of one of the AACR presentations. "These presentations provide
additional insight into the mechanisms that act to selectively destroy the
blood vessels supporting tumor growth and spread and also to reverse the
ability of tumors to suppress the body's natural immune response, resulting in
the mobilization of important inflammatory and other anti-tumor components of
the immune system. Together, the studies provide compelling evidence suggesting
that PS-targeting antibodies facilitate an important cytokine shift in the
tumor environment that subsequently encourages multiple types of immune system
cells to mount anti-tumor responses."
In a presentation1 on Monday, a
series of preclinical studies by a team of scientists from Peregrine
Pharmaceuticals and Affitech A/S used a fully human anti-PS antibody, PGN635,
to confirm previous observations that in vitro, anti-PS antibodies stimulate
the tumor microenvironment to recruit monocytes and other immune cells to the
tumor with resulting anti-tumor effects, most likely via cell-mediated
mechanisms such as antibody-dependent cell-mediated cytotoxicity (ADCC). Their
data further define the role of anti-PS antibodies in mediating tumor cell
cytotoxicity and the tumor microenvironment, showing that the anti-PS antibody
induced a sequential release of cytokines and beta-chemokines and stimulated
enhanced macrophage recruitment to tumors. Furthermore, the researchers showed
that in vitro, PGN635 induced antibody-dependent death of endothelial cells,
the same cell type found in the tumor vasculature, a key target of anti-PS cancer
therapy. The studies also demonstrated the anti-tumor potential of PGN635 in
vitro and in a number of animal cancer models.
"Data from our experiments has
helped to clarify details regarding the mechanisms responsible for the
anti-tumor results observed with Peregrine's PS-targeting antibodies,"
said Dr. Monica Friedrich, a Peregrine research scientist and lead author of
the study. "In data presented at this conference last year, we
demonstrated that our fully human antibody PGN635 localizes to tumors and
causes an increase in several inflammatory cytokines while decreasing an
important anti-inflammatory cytokine. The new data we present confirms that
PGN635 also triggers immune cells to produce other chemokines and cytokines
that have the potential to alter the suppressed immune environment commonly
found in tumors, attracting additional immune cells and stimulating more
aggressive anti-tumor responses. We believe this upregulation of the immune
response contributes to the encouraging anti-tumor effects demonstrated by
PGN635 and other anti-PS antibodies."
A second study2 presented on Monday
by researchers from UT Southwestern Medical Center and Affitech demonstrated
the ability of Peregrine's fully human PS-targeting antibody PGN632 to promote
the maturation of dendritic cells, important antigen-presenting cells of the
immune system. In the in vitro studies, immature dendritic cells cultured in
the presence of PGN632 exhibited a significant increase in the production of
inflammatory cytokines and chemokines. PGN632 also induced an increase in the
expression of cell-surface molecules that are indicative of mature dendritic
cells and that assist in antigen presentation functions, as well as in
stimulating T-cell proliferation.
Dr. Xianming Huang, assistant professor
of pharmacology at UT Southwestern Medical Center and lead author of the study,
noted, "Dendritic cells are the professional antigen-presenting cells of
the immune system and they play a crucial role in initiating adaptive immune
responses. Dendritic cells must be mature, or activated, to be effective, yet
tumors and other pathogens such as viruses often possess the ability to
undermine this maturation, thereby suppressing the immune response. The results
presented today suggest that by blocking exposed PS, anti-PS antibodies have
the potential to promote dendritic cell maturation in the body and thereby
stimulate a more effective immune response."
The fully human PS-targeting
antibodies in these studies were developed through Peregrine's collaboration
with Affitech A/S. The study by Dr. Huang, et al. was partly supported by the
Gillson Longenbaugh and Meredith D. Chesler Foundations.
Peregrine president and CEO Steven
King commented, "It is noteworthy that these studies were primarily
conducted using our new fully human antibodies, which could serve as the basis
for the next generation of anti-PS therapies. Our PS-targeting antibody
platform now includes several promising antibodies in preclinical evaluation
that vary in their binding profile and in their specific immunomodulatory
activity. The unique functional characteristics of these different antibodies
open the door to new product candidates and extended applications for our
anti-PS technology. We are more encouraged than ever that our anti-PS platform
has very broad potential, and we look forward to further development of our
growing preclinical pipeline of PS-targeting candidates both through internal
efforts and collaborations with partners."
About Peregrine's Clinical Stage
Anti-PS Antibody Bavituximab
Peregrine's clinical stage
PS-targeting antibody bavituximab binds to the cellular membrane component
phosphatidylserine (PS) that is usually located inside cells, but which becomes
exposed on the outside of the cells that line the blood vessels of tumors,
creating a specific target for anti-cancer treatments. By binding to PS,
bavituximab is believed to help mobilize the body's immune system to destroy
the tumor and the tumor blood vessels. Bavituximab currently is in two separate
Phase II combination therapy trials for the treatment of advanced breast cancer
and a Phase II combination therapy trial for the treatment of non-small cell
lung cancer. A Phase I bavituximab monotherapy trial in advanced solid cancers
is also continuing.
###
1 Monica L. Friedrich, Claudia I.
Guevara, Longen Zhou, Daniel Falcon, Cristina Bautista, Michael Brown, Anita
Kavlie, Connie Chang, Bruce Freimark. Peregrine Pharmaceuticals, Inc., Tustin,
CA, Affitech AS, Oslo, Norway. Induction of chemokines and cytokines by human
phosphatidylserine antibody facilitates cell-mediated anti-tumor responses. In:
Proceedings of the 100th Annual Meeting of the American Association for Cancer
Research; 2009 Apr 18-22; Denver, CO. Philadelphia (PA): AACR; 2009. Abstract
2408
2 Xianming Huang, Dan Ye, Philip
Thorpe, Anita Kavlie. UT Southwestern Medical Ctr., Dallas, TX, Affitech AS,
Oslo, Norway. A novel anti-phosphatidylserine antibody that promotes dendritic
cell maturation. In: Proceedings of the 100th Annual Meeting of the American Association
for Cancer Research; 2009 Apr 18-22; Denver, CO. Philadelphia (PA): AACR; 2009.
Abstract 2407
Peregrine Pharmaceuticals Reports Positive Preliminary Data
From Phase II Bavituximab Lung Cancer Trial
- Updated Data from Initial Cohort Shows 11 of 17 Evaluable Patients Receiving
Bavituximab in Combination with Carboplatin + Paclitaxel Achieved an Objective
Tumor Response -
- Patient Dosing Initiated in Expansion Stage of Trial with Target of Enrolling
49 Patients Overall -
TUSTIN, Calif., April 20 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals,
Inc. (NASDAQ:PPHM), today announced that updated preliminary data from the
initial cohort of 21 patients in its Phase II trial evaluating bavituximab in
combination with carboplatin and paclitaxel showed that 11 of 17 evaluable
patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)
achieved an objective tumor response according to RECIST criteria, after
completing the maximum six treatment cycles. The company also reported
that patient dosing is underway in the expansion stage of the trial, which will
enroll an additional 28 patients for a total of 49 patients overall.
"We are very pleased to see these additional objective tumor responses in
this difficult-to-treat cancer following the full regimen of six treatment
cycles of bavituximab and chemotherapy," said Steven W. King, president
and CEO of Peregrine. "These updated results build on the impressive
data we reported after only four treatment cycles, which had already exceeded
the pre-defined number of objective tumor responses needed to expand the trial
to the larger cohort."
Mr. King added, "The tumor response data to date from this trial compares
favorably to published studies with current standard-of-care lung cancer
treatments, and we are looking forward to seeing results from the entire study.
With dosing now underway in the expanded patient cohort, we expect to
resume the brisk pace of enrollment achieved in the first cohort, with the goal
of completing patient enrollment around mid-year. We intend to provide
further updates as patient treatment and follow-up continue in the coming
months."
The primary objective of the multi-center, open-label Phase II study is to
assess the overall response rate to bavituximab with carboplatin and
paclitaxel. In the trial's Simon two-stage design, 21 patients with
previously untreated locally advanced or metastatic NSCLC were initially
enrolled and 17 of these patients were deemed evaluable. In this initial
cohort, 11 of the 17 evaluable patients achieved an objective tumor response by
the time that treatment with the combination of bavituximab, carboplatin and
paclitaxel was completed. Eight of the 11 objective tumor responses were
confirmed by at least one repeat scan no less than four weeks after the
criteria for response were first met.
Secondary objectives of the study include measuring time to tumor progression,
duration of response, overall patient survival and safety parameters.
Patients in the study are evaluated regularly for tumor response
according to RECIST criteria. Patients may continue to receive
bavituximab as monotherapy after completion of chemotherapy as long as the
cancer does not progress and side effects are acceptable. The trial is being
conducted in India according to International Conference on Harmonization (ICH)
and Good Clinical Practices (GCP) guidelines.
Lung cancer is a major cause of cancer deaths worldwide. According to the
American Cancer Society, lung cancer is the second most commonly diagnosed
cancer in men and women in the U.S. and is the leading cause of cancer deaths.
It estimates that in 2008, there were approximately 215,020 new cases of lung
cancer in the U.S. and an estimated 161,840 lung cancer deaths. NSCLC is
the most common type of lung cancer, accounting for approximately 85-90% of
lung cancer cases.
Bavituximab is a monoclonal antibody that binds to the cellular membrane
component phosphatidylserine (PS) that is usually located inside cells, but
which becomes exposed on the outside of the cells that line the blood vessels
of tumors, creating a specific target for anti-cancer treatments. By
binding to PS, bavituximab is believed to help mobilize the body's immune
system to destroy the tumor and the tumor blood vessels. Bavituximab
currently is in two separate Phase II combination therapy trials for the
treatment of advanced breast cancer and a Phase II combination therapy trial
for the treatment of non-small cell lung cancer. A Phase I bavituximab
monotherapy trial in advanced solid cancers is also continuing.
About Peregrine Pharmaceuticals
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio
of innovative monoclonal antibodies in clinical trials for the treatment of
cancer and serious viral infections. The company is pursuing three separate
clinical programs in cancer and hepatitis C virus infection with its lead
product candidates bavituximab and Cotara(R). Peregrine also has in-house
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.
Peregrine Pharmaceuticals Reports Positive Data in Second
Phase II Bavituximab Breast Cancer Trial
- Updated Data from Initial Cohort Shows Nine of 14 Evaluable Patients
Receiving Bavituximab in Combination with Carboplatin + Paclitaxel Achieved an
Objective Tumor Response -
- Patient Dosing Underway in Expansion Stage of Trial with Target of Enrolling
46 Patients Overall -
TUSTIN, Calif., April 27 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals,
Inc. (NASDAQ:PPHM), today announced that updated preliminary data from its
Phase II trial evaluating bavituximab in combination with carboplatin and
paclitaxel in advanced breast cancer showed that nine of 14 evaluable patients
in the initial cohort achieved an objective tumor response after a maximum of
six treatment cycles according to RECIST criteria. The company also
reported that patient dosing is underway in the expansion stage of the trial,
which will enroll an additional 31 patients for a total of 46 advanced breast
cancer patients overall.
"We are pleased to see these additional objective tumor responses in these
advanced breast cancer patients who received up to six treatment cycles of
bavituximab and chemotherapy," said Steven W. King, president and CEO of
Peregrine. "These updated results further strengthen the positive
data we reported in February after two treatment cycles, which had already
exceeded the pre-defined number of objective tumor responses needed to expand
the trial to the larger cohort."
Mr. King added, "While preliminary, these data along with early positive
data from our other two bavituximab Phase II cancer trials are increasing our
optimism that bavituximab in combination with chemotherapy could prove to be a
valuable new option for the treatment of a variety of solid cancers. We
look forward to reporting data from this expanded trial in the coming
months."
The primary objective of the multi-center, open label Phase II study is to
assess the overall response rate to bavituximab with carboplatin and
paclitaxel. In the trial's Simon two-stage design, 15 patients with
locally advanced or metastatic breast cancer were initially enrolled and 14 of
these patients were deemed evaluable. In this initial cohort, nine of the
14 evaluable patients achieved an objective tumor response by the time that
treatment with the combination of bavituximab, carboplatin and paclitaxel was
completed.
Secondary objectives of the study include measuring time to tumor progression,
duration of response, overall patient survival and safety parameters.
Patients in the study are evaluated regularly for tumor response
according to RECIST criteria. Patients may continue to receive bavituximab
as monotherapy after completion of chemotherapy as long as the cancer does not
progress and side effects are acceptable. The trial is being conducted in
India according to International Conference on Harmonization (ICH) and Good
Clinical Practices (GCP) guidelines.
The World Health Organization reports that breast cancer is the most commonly
diagnosed cancer in women and is second only to lung cancer as a leading cause
of female cancer deaths. The National Cancer Institute estimates that
approximately 182,460 U.S. women were diagnosed with breast cancer in 2008 and
40,480 women died of the disease in the U.S. alone.
Bavituximab is a monoclonal antibody that binds to the cellular membrane
component phosphatidylserine (PS) that is usually located inside cells, but
which becomes exposed on the outside of the cells that line the blood vessels
of tumors, creating a specific target for anti-cancer treatments. By
binding to PS, bavituximab is believed to help mobilize the body's immune
system to destroy the tumor and the tumor blood vessels. Bavituximab
currently is in a separate Phase II trial in combination with docetaxel for the
treatment of advanced breast cancer and a Phase II combination therapy trial
for the treatment of non-small cell lung cancer. A Phase I bavituximab
monotherapy trial in advanced solid cancers is also continuing.
About Peregrine Pharmaceuticals
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio
of innovative monoclonal antibodies in clinical trials for the treatment of
cancer and serious viral infections. The company is pursuing three separate
clinical programs in cancer and hepatitis C virus infection with its lead
product candidates bavituximab and Cotara(R). Peregrine also has in-house
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 rate of objective tumor response for the expansion stage of this
trial will not be consistent with the objective tumor response experienced in
the first stage of the trial and the risk that the standard carboplatin and
paclitaxel response rate will not be improved as a result of the combination
therapy. 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 company's SEC reports including, but
not limited to, the annual report on Form 10-K for the year ended April 30,
2008 and the quarterly report on Form 10-Q for the quarter ended January 31,
2009. 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.
Peregrine Pharmaceuticals Completes Patient Enrollment in
its Phase II Trial of Bavituximab Plus Docetaxel in Breast Cancer Patients
-Preliminary Data from This Trial to be Presented at ASCO-
-First Phase II Trial in Bavituximab Cancer Program to Complete Patient
Enrollment-
TUSTIN, Calif., May 4 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals, Inc.
(NASDAQ:PPHM) today announced that it has completed enrollment in its Phase II
trial evaluating bavituximab in combination with docetaxel in advanced breast
cancer patients. The planned 46 patients have been enrolled and are
currently undergoing treatment and follow-up. The primary objective of the
multi-center, open-label Phase II study is to assess the overall response rate
to bavituximab and docetaxel. The company also announced that preliminary
data from this trial has been accepted for oral presentation at the upcoming
American Society of Clinical Oncology (ASCO) Annual Meeting.
"Completion of patient enrollment in this Phase II study in advanced breast
cancer patients represents a milestone for Peregrine's bavituximab cancer
program, as this is the first of our three ongoing Phase II cancer trials to
complete patient enrollment," said Steven W. King, president and CEO of
Peregrine. "We will continue to assess patients in this study over
the coming months and look forward to reporting updated preliminary results
from the trial at the upcoming ASCO Annual Meeting."
In this trial's Simon two-stage design, 15 patients with advanced breast cancer
were enrolled in the trial's first cohort. Ten of the 14 evaluable patients in
this cohort demonstrated an objective tumor response according to RECIST
criteria. These results compare favorably with historical response rates
for docetaxel as solo therapy in advanced breast cancer patients and exceeded
the pre-specified primary efficacy endpoint needed to expand enrollment in the
trial. An additional 31 patients were then enrolled to achieve the
planned study total of 46 patients overall.
Secondary objectives of the study include measuring time to tumor progression,
duration of response, overall patient survival and safety parameters.
Patients in the study are evaluated regularly for tumor response
according to RECIST criteria. Patients may continue to receive
bavituximab as monotherapy after completion of chemotherapy as long as the
cancer does not progress and side effects are acceptable. The trial is
being conducted in the Republic of Georgia according to International
Conference on Harmonization (ICH) and Good Clinical Practices (GCP) guidelines.
The World Health Organization reports that breast cancer is the most commonly
diagnosed cancer in women and is second only to lung cancer as a leading cause
of female cancer deaths. The National Cancer Institute estimates that
approximately 182,460 U.S. women were diagnosed with breast cancer in 2008 and
40,480 women died of the disease in the U.S. alone.
Bavituximab is a monoclonal antibody that binds to the cellular membrane
component phosphatidylserine (PS) that is usually located inside cells, but
which becomes exposed on the outside of the cells that line the blood vessels
of tumors, creating a specific target for anti-cancer treatments. By
binding to PS, bavituximab is believed to help mobilize the body's immune
system to destroy the tumor and the tumor blood vessels. Bavituximab
currently is in two separate Phase II trials in combination with paclitaxel and
carboplatin for the treatment of advanced breast cancer and non-small cell lung
cancer and in a third Phase II trial in combination with docetaxel in advanced
breast cancer patients. A Phase I bavituximab monotherapy trial in
advanced solid cancers is also continuing.
About Peregrine Pharmaceuticals
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio
of innovative monoclonal antibodies in clinical trials for the treatment of
cancer and serious viral infections. The company is pursuing three separate
clinical programs in cancer and hepatitis C virus infection with its lead product
candidates bavituximab and Cotara(R). Peregrine also has in-house
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 rate of objective tumor response for the expansion stage of this
trial will not be consistent with the objective tumor response experienced in
the first stage of the trial and the risk that the standard carboplatin and
paclitaxel response rate will not be improved as a result of the combination
therapy. 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 company's SEC reports including, but
not limited to, the annual report on Form 10-K for the year ended April 30,
2008 and the quarterly report on Form 10-Q for the quarter ended January 31,
2009. 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.
