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RECENTLY
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KEY DATES IN PEREGRINE'S HISTORY
Peregrine Pharmaceuticals
The Company Line:
Peregrine Pharmaceuticals, Inc.,
located in Tustin, California, is a biopharmaceutical company engaged in the
research, development, manufacture and commercialization of cancer therapeutics
and cancer diagnostics through a series of proprietary platform technologies
using monoclonal antibodies.
In January 2002, they announced the
formation of a wholly-owned subsidiary, Avid Bioservices, Inc.
("Avid"). Avid provides an array of contract manufacturing services,
including contract manufacturing of antibodies and proteins, cell culture
development, process development, and testing of biologics for
biopharmaceutical and biotechnology companies under current Good Manufacturing
Practices. Avid's manufacturing facility is located in Tustin, California,
adjacent to Peregrine’s offices.
With the addition of Avid, Peregrine’s
business is now organized into two reportable operating segments: (i)
Peregrine, the parent company, is engaged in the research and development of
cancer therapeutics and cancer diagnostics through a series of proprietary
platform technologies using monoclonal antibodies, and (ii) Avid, is engaged in
providing contract manufacturing and development of biologics to
biopharmaceutical and biotechnology businesses.
Their main focus is on the development
of collateral targeting agent technologies. Collateral targeting agents
typically use antibodies that bind to or target components found in or on most
solid tumors. An antibody is a molecule that humans and other animals create in
response to disease. In pre-clinical and/or clinical studies, these collateral
targeting antibodies are capable of targeting and delivering therapeutic
killing agents that kill cancerous tumor cells. Peregrine currently has
exclusive rights to over 80 issued U.S. and foreign patents protecting various
aspects of their technology and have additional pending patent applications
that they believe will further strengthen their patent position in the
collateral targeting agent field.
Peregrine’s VTA and VEA technologies are
currently in preclinical development. Their first TNT-based product,
Cotara(TM), is currently in a Phase I clinical study at Stanford University
Medical Center primarily for the treatment of colorectal cancer. In addition,
during February 2003, they received protocol approval from the U.S. Food and
Drug Administration ("FDA") to initiate a registration study using
Cotara(TM) for the treatment of brain cancer. (They presently do not anticipate
treating any additional brain cancer patients while actively seeking a
licensing or development partner for the Cotara(TM) program under the approved
registration trial.)
In addition to collateral targeting
agents, Peregrine has a direct tumor-targeting antibody, Oncolym(R), for the
treatment of Non-Hodgkins B-cell Lymphoma. During fiscal year 2002, they
suspended patient enrollment for this study and are currently in the process of
closing the current Phase I/II clinical trial while they seek to license or
partner the Oncolym(R) product.
Peregrine does not anticipate continuing with clinical studies without a
licensing or development partner for this technology.
Avid's main focus is to provide an array of contract manufacturing services, including contract manufacturing of antibodies and proteins, cell culture development, process development, and testing of biologics for third party customers under current Good Manufacturing Practices.
MY ORIGINAL WEBPAGE INTRODUCTION TO
PEREGRINE:
PEREGRINE PHARMACEUTICALS is a
biopharmaceutical company focused on the development, commercialization, and
licensing of unique technologies for the treatment of cancer, primarily based
on its Collateral Targeting Technologies. These technologies target cell
structures and cell types that are common among solid tumor cancers, giving them
broad applicability across various tumor types. In clinical and pre-clinical
studies, collateral targeting technologies have been shown to deliver various
anti-cancer compounds selectively to the tumor site without causing damage to
surrounding healthy tissue.
Peregrine
has 3 different Collateral Targeting Technologies: Tumor Necrosis Therapy
(TNT), Vascular Targeting Agents (VTA) and Vasopermeation Enhancement Agents
(VEA) and 1 Direct Tumor Targeting Agent, Oncolym®.
First, Tumor Necrosis Therapy (TNT): TNT was
invented by Dr. Alan Epstein of the USC Medical
Center. TNT compounds attack tumors from the inside out using monoclonal antibodies loaded with radioisotopes that attach to the
DNA inside dead or dying cancer cells; once inside, the radioisotopes bombard
neighboring tumor cells without harming healthy tissue. The company's lead
anti-cancer drug, Cotara™, is currently in a multi-center Phase II clinical
study for the treatment of brain cancer and a Phase I clinical study for the
treatment of soft tissue sarcoma and biliary cancers. Cotara™ has received fast track and orphan drug status from the FDA. The FDA has
also approved the protocol for a Phase III clinical study for the treatment of
brain cancer with Cotara™. The company expects patient enrollment to begin as
soon as a partner is found to fund the trials.
Second, Vascular Targeting Agents (VTA):
Peregrine is also developing VTA compounds that cut off the blood supply to
tumors by forming blood clots in the tumor's blood vessels. Dr. Philip Thorpe and his lab at the University
of Texas Southwestern Medical Center are mainly responsible for this research.
Before Dr. Thorpe's work, scientists were trying to stop the runaway growth of
new blood vessels that allows cancer to spread, a field pioneered by Dr. Judah
Folkman called anti-angiogenesis. Dr. Thorpe uses an
approach that severs the cancer's original blood vessels, using the
body's own clotting mechanisms instead of a chemical.
Additionally, other benefits of Vascular Targeting Agents
are as follows:
VTAs are designed to address the complete spectrum of
solid tumors, whereas other approaches require the development of different,
specific drugs for varying types of solid tumors.
VTAs are designed to target tumor-associated endothelial
cells, so drug resistant mutations are unlikely to occur.
Damaging one or two blood vessels can cause thousand of
tumor cells to die. The new necrotic cells
may then be susceptible to TNT targeting.
Dr. Folkman has said about Dr. Thorpe’s work: “This is
very promising and very elegant work.”
Peregrine announced in August of 2001, that it has
completed exclusive worldwide licenses for two new novel compounds from Dr.
Thorpe and his staff. One antibody targets phosphatidylserine (PS) on the
surface of tumor endothelial cells, which line blood vessels in tumors. They
discovered that PS is a highly specific marker of tumor endothelium. In normal
endothelial and other living cells, PS is located only on the inner cytoplasmic
surface of the cell membrane, but in tumor endothelial cells, PS is located on
both surfaces. Anti-PS antibodies bind specifically to tumor endothelial cells
after injection into animals with tumors, because only the external PS is
available to antibodies in the blood. The unconjugated antibodies inhibit
endothelial cell growth in culture, damage tumor vasculature and strongly
retard tumor growth in mice. "The pre-clinical anti-tumor data for this
class of antibodies are impressive," said Thorpe.
The second antibody is 2C3, an antibody that neutralizes
vascular endothelial growth factor (VEGF). The 2C3 antibody's method of action
is as an anti-angiogenesis
compound. Anti-angiogenesis compounds work by blocking the formation of new
blood vessels from existing vessels. By stopping the growth of cancer blood
vessels, the progression of the cancer or the establishment of metastases can
be inhibited. Peregrine believes this technology is complementary to its
collateral targeting agents and other existing cancer therapeutics.
"Unlike most anti-VEGF antibodies, the 2C3 antibody
blocks the binding of VEGF to the blood vessel receptors involved in tumor
angiogenesis, without blocking the binding of VEGF to receptors involved in
non-cancer cell activities, such as macrophage functions. This could translate
into a better toxicity profile than current anti-VEGF antibodies that do not
discriminate between these receptors," stated Thorpe.
Third, Vasopermeation Enhancement Agents (VEA): VEA’s
are a new class of drugs, which increase the therapeutic index of solid tumor
therapeutic agents. VEA technology consists of a blood vessel permeation agent
with specificity for tumor tissues. Pretreatment of the patient with these
compounds drastically increases the uptake of the chemotherapeutic agent to the targeted
tissue without increasing the concentration in normal tissue. Since the
Vasopermeation Agent can be used for any solid tumor and with any chemotherapeutic
agent, VEA therapy will have wide application for both existing therapeutic
regimens and new cancer drugs. This technology has been tested
in rodents bearing xenographic human tumors
followed by anticancer therapy consisting of large biologics as well as smaller
synthetic molecules. “In all cases, tumor uptake was 3.8 to 4.8 times higher in
treated animals versus controls, which did not receive pretreatment with the
VEA technology.” (Click here for link to
reference.)
All preclinical studies for the VEA technology were
conducted at the University of Southern California (USC), under the leadership
of Dr. Alan Epstein, M.D., Ph.D., the inventor of the VEA technology. Two
physicians at Keio University in Tokyo, Japan have corroborated results of the
Dr. Epstein’s preclinical studies in the VEA technology. These researchers
achieved similar increases in tumor uptake of anti-cancer agents through
pretreatment with the Vasopermeation Enhancement concept. Findings of this
study, which was conducted independently from Peregrine, were presented in 1997
at the Annual Society of Nuclear Medicine Meeting.
The company believes that the market for their VTA and VEA
drugs could exceed $2 billion per year.
The company also has a Direct Tumor Targeting Agent called
Oncolym® for the treatment of advanced
non-Hodgkin’s B-cell Lymphoma, which is currently in a multi-center Phase I/II.
Oncolym® has also received FDA “orphan drug” status, entitling Peregrine to
exclusive marketing rights and tax credits.
Peregrine announced the formation of Avid Bioservices,
Inc., a wholly owned subsidiary, on January 8, 2002. Avid will
provide contract services for biopharmaceutical and biotechnology businesses
including manufacturing of products under current Good Manufacturing Practices
(cGMP), cell culture, process development, and testing of biologics. Avid
operates in facilities adjacent to Peregrine’s Tustin, California headquarters.
Avid will utilize mammalian cell culture ranging from 30 liter to 300 liter
scale of production and will focus on two biopharmaceutical segments:
monoclonal antibodies and recombinant proteins.
(most highlighted words above are additional links to
information)
Click here for Hawk and Associates
Peregrine Info Kit
Click here for FDA Fast Track and
Accelerated Approval Info
Significant
Peregrine Events in Fiscal 2003
The U.S. FDA granted approval to start a
single registration study for Cotara(TM) in recurrent glioblastoma multiforme, a
deadly form of brain cancer. The study is planned for the U.S., Europe and
Canada. Peregrine intends to find a partner for Cotara to fund the registration
study.
The first full year of Avid Bioservices
operations ended with revenue of $3.35 million. Avid completed its initial
contracts and delivered clinical product to those clients. Avid signed
additional contracts for continued production and projected revenue growth.
Cotara received Orphan Drug Status in Europe.
Steven King was promoted from chief operating
officer to chief executive officer.
The company signed a worldwide licensing
agreement with Schering, AG for the development of Vascular Targeting Agents
with radioactive isotopes for
imaging and diagnostics.
The company was granted six new patents
covering its Vascular Targeting Agent and Vasopermeation Enhancement Agent
platform technologies, broadening and strengthening the company's patent
position and intellectual property in these fields of research.
Pre-clinical progress continued during fiscal
year 2003. Researchers at the
University of Texas Southwestern Medical Center at Dallas have published data detailing the anti-tumor
effects of the 2C3 antibody. The study, which appears in the most recent issue
of Angiogenesis, demonstrated that administration of 2C3 to tumor-bearing mice
inhibited tumor growth by 75%, as compared to a control group. The company has an exclusive license to the
2C3 antibody with University of Texas Southwestern Medical Center.
The year saw publication of radiolabeled
Tumor Necrosis Therapy data from a Phase I/II inoperable lung cancer study from
clinical research conducted in
China. The study showed radiolabeled TNT demonstrated significant tumor
regressions in late stage inoperable lung cancer. The Phase I/II study compared
the efficacy of three different methods of administration of 131I-chTNT for
patients with inoperable late stage lung cancer: intravenous, intratumoral, and
a combination of intravenous plus intratumoral injection. The results
demonstrated that the method of intratumoral injection alone achieved a 56%
complete and partial tumor remission rate. The combined intravenous plus
intratumoral injection method achieved 40% and the intravenous method alone
achieved 9% tumor remission rate. The disease control rate for all three
methods of treatment, including complete and partial remission and stable
disease, was 88% for the 43 patients assessed in the study. The highest
therapeutic effect was obtained by using common bronchoscopy and computer
tomography (CT) scan instruments in a new technique to directly infuse the
tumor with lethal doses of 131I-chTNT.
Company representatives presented at four
major industry conferences including the American Society of Clinical Oncology
(ASCO) Annual Meeting, the Society
of Nuclear Medicine's Annual Meeting, the Bio2002 Annual Conference, The 2002
World Antibody Summit, and the First
International Conference on Vascular Targeting. These presentations showcased
Peregrine's technologies and created enhanced exposure in the scientific and
business communities.
Company technology was published in seven
scientific peer review journals, including prestigious journals such as The
Proceedings of the National Academy of Sciences and Cancer Research. These
publications highlighted research on Peregrine's Tumor Necrosis Therapy,
Vascular Targeting Agents, Anti-Angiogenesis Agents and Lym-1 technologies.
The company raised $9 million under equity and debt financing arrangements.
BELOW ARE LINKS TO MANY PAGES, ARTICLES AND
INFORMATION RELATED TO PEREGRINE’S TECHNOLOGY, PERSONNEL, COMPANY AND THE
SCIENTISTS THAT ARE WORKING TO TREAT AND ULTIMATELY CURE CANCER.
PLEASE VISIT THE MANY LINKS AND DON’T FORGET
TO BOOKMARK THIS PAGE FOR EASY REFERENCE.
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PEREGRINE COMPANY INFORMATION |
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AVIDBIO LINKS (Peregrine Subsidiary) |
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PEREGRINE’S PARTNERS AND COMPETITORS |
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DR. THORPE LINKS |
DR. EPSTEIN LINKS |
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VTA |
TNT/COTARA |
Genetic Research Article - link by
terrygd
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Mutant Factor X - link by terrygd
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China Lung Cancer Results
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PS
AND 2C3
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VEA LINKS
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VEA Info
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ABSTRACTS
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1999 CCR Paper
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ONCOLYM LINKS |
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Dr. DeNardo's Lym-1 Paper
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NHL Therapy Slideshow
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UC Davis Trial Info
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POST OF THE DAY |
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HUMOR |
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ENDOCYTE INFO (non
PPHM related) |
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CONTRIBUTORS and VALUED POSTERS
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EZLibra |
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BEST BOARD FOR
PERTINENT, INFORMATIVE DISCUSSION Terry's Peregrine Palace Thanks to all who
post there!
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Don’t Bother |
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YaHoo! |
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last
update: 11/14/2003 9:42 PM
Since 01 Jan 2002
