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Wednesday, 03/02/2005 9:51:03 AM

Wednesday, March 02, 2005 9:51:03 AM

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HERES THE WHOLE POST KEN
Journal of Clinical Oncology Publishes Significant Anti-Tumor Activity of
Tumor Necrosis Therapy for Treating Patients With Advanced Lung Cancer

TUSTIN, Calif., March 2 /PRNewswire-FirstCall/ -- Peregrine
Pharmaceuticals, Inc. (Nasdaq: PPHM) announced today the publication of data
in the Journal of Clinical Oncology demonstrating significant anti-tumor
activity in a study of 107 patients with advanced lung cancer treated at eight
oncology centers in China with an iodine-131 radiolabeled Tumor Necrosis
Therapy antibody (131I-TNT). In the published article, approximately 90% of
patients treated with 131I-TNT had stable disease or better with 3.7%
achieving complete responses, 30.8% achieving partial responses involving at
least 50% shrinkage of their tumors and 55.1% achieving stable disease
(representing no change in the tumor mass). The Objective Response Rate (ORR)
to the therapy was 34.6% as measured by World Health Organization criteria
(WHO).
According to the study, radioimmunotherapy with Iodine-131 chimeric TNT
was well tolerated and can be used intravenously or intratumorally to treat
refractory tumors of the lung. While the overall response rate in patients
treated intravenously and intratumorally were approximately 36% and 33%,
respectively, the severity of side effects related to the drug was lower in
patients treated intratumorally. ORR was defined according to WHO criteria
for measuring solid tumors as patients with a complete response defined as
disappearance of all known lesion(s), or partial response defined as at least
a 50% decrease; confirmed at four weeks.
"The publication of this data in the Journal of Clinical Oncology affirms
the TNT approach to treating lung cancer," said Steven King, president and CEO
of Peregrine. "The recent completion of enrollment in a Phase I safety study
using our similar product Cotara(R), along with this promising data in the
treatment of lung cancer, opens the possibility for similar trials in the
U.S."
"This compelling tumor response data in advanced lung cancer and the
clinical data we have generated in brain cancer demonstrate TNT's ability to
clinically benefit people suffering from cancer," stated Joe Shan, Director of
Clinical Development at Peregrine Pharmaceuticals. "We are looking forward to
initiating clinical enrollment in our brain cancer trial in collaboration with
the New Approaches to Brain Tumor Therapy consortium."
About Cotara(R) and Tumor Necrosis Therapy (TNT) Platform
The company is developing a radioactive chimeric TNT antibody that it has
trademarked Cotara(R) for the treatment of cancer. Cotara(R) is designed to
bind to the dead or dying tissue within the tumor and, once bound, its
radioisotope irradiates nearby cells resulting in the death of nearby tumor
cells.
Rapidly growing tumors quickly outgrow their blood supply resulting in a
region of tumor cells that do not receive adequate oxygen, nutrients and waste
removal. The accumulation of dying cells results in the formation of a dead,
or necrotic, core present in virtually all solid tumors beyond a very small
size. TNT-based products directly target and bind to dead and dying tumor
cells found in virtually all solid tumors. By using the necrotic core as a
stable anchorage in the heart of a tumor, TNT-based therapeutic agents have
the potential to deliver therapeutic agents preferentially targeted to
virtually all solid tumors, including brain, lung, colon, breast, liver,
prostate and pancreatic cancers.
The company is working with New Approaches to Brain Tumor Therapy (NABTT)
Consortium to initiate the first part of Peregrine's U.S. Food and Drug
Administration (FDA)-approved product registration trial using Cotara(R) to
treat patients with brain cancer. Peregrine has also completed enrollment in a
Phase I Cotara(R) clinical trial for the treatment of colorectal carcinoma at
Stanford University Medical Center and is working closely with scientific
advisors to design Phase II studies using Cotara(R) for other solid tumor
indications. In addition, a TNT-based agent similar to Cotara(R) was developed
under a licensing agreement in China and has received marketing approval for
the treatment of advanced lung cancer.
About Peregrine Pharmaceuticals
Peregrine Pharmaceuticals (Peregrine) is a biopharmaceutical company
primarily engaged in the research, development, manufacture and
commercialization of cancer therapeutics and diagnostics through a series of
proprietary platform technologies. The company is primarily focused on
discovering and developing products that affect blood vessels and blood flow
in cancer and other diseases. Peregrine's vascular research programs fall
under several different proprietary platforms, including Anti-Phospholipid
Therapy (APT), Vascular Targeting Agents (VTAs), Anti-Angiogenesis and
Vasopermeation Enhancement Agents (VEAs).
Peregrine recently received approval from the FDA for its Tarvacin(TM)
Phase I study for the treatment of cancer. Tarvacin(TM), a novel anti-cancer
agent, is part of Peregrine's Anti-Phospholipid Therapy (APT) platform, which
binds directly to tumor blood vessels to inhibit tumor growth and development.
The company plans on initiating the approved Phase I study in the near term.
For other recent news or additional information about the company, please
visit http://www.peregrineinc.com




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