- Cotara(R) Appears Safe and Well Tolerated in Dosimetry and Phase II
Trials, with Some Patients Already Past the Expected Median Average
Survival Time for This Population -
- Data From Dosimetry Trial Accepted for Presentation at 2008 ASCO Annual
Meeting -
TUSTIN, Calif., March 11 /PRNewswire-FirstCall/ -- Peregrine
Pharmaceuticals, Inc. (Nasdaq: PPHM), a clinical stage biopharmaceutical
company developing monoclonal antibodies for the treatment of cancer and
hepatitis C virus infection, today released an update from two clinical
trials assessing its targeted therapy Cotara(R) in the treatment of
glioblastoma multiforme (GBM), the most deadly form of brain cancer. The
Cotara clinical update covers the first cohort of patients in its dosimetry
trial as well as experience to date in an ongoing Phase II safety and
efficacy trial. In patients treated in the studies, Cotara appears to be
safe and well tolerated, with no dose-limiting adverse events. Patients who
are continuing in the trials are being monitored for safety and overall
survival, with several surpassing the median expected survival time for
relapsed GBM patients. The recent addition of new clinical sites in both
the dosimetry and Phase II trials is expected to help accelerate the pace
of patient enrollment going forward. The company also announced that data
from the first patient cohort in the dosimetry trial has been accepted for
presentation at the 2008 ASCO Annual Meeting.
"We are encouraged by early results from these two Cotara clinical
studies and look forward to presenting data from the dosimetry trial at the
upcoming ASCO Annual Meeting," said Steven W. King, president and CEO of
Peregrine. "In view of the short expected survival time of approximately
six months in this patient population, it is promising that we have early
GBM patients in these trials who have survived past the six-month
timeframe, with one patient now surviving 15 months post-treatment."
The open-label Phase I dosing and dosimetry study at U.S. brain cancer
centers is enrolling GBM patients with recurrent disease. Patients in this
trial receive an initial imaging dose of Cotara before receiving the
therapeutic dose. The study's main objectives are to confirm the maximum
tolerated dose, to determine radiation dosimetry and to assess overall
patient survival, progression-free survival and the proportion of patients
alive at six months following Cotara administration. In the three GBM
patients enrolled in the first cohort, Cotara was safe and well tolerated,
with no dose-limiting toxicities. Patients have been followed
post-treatment to determine overall survival, with the first treated
patient currently surviving 15 months post-treatment and the last treated
patient currently surviving four months post-treatment. Dosimetry analysis
indicates that Cotara was concentrated only in the tumor in these patients,
and not in other organs.
Mr. King added, "With enrollment of the second patient cohort underway,
we welcome Dr. William Shapiro of the Barrow Neurological Institute as
principal investigator of our newest dosimetry study clinical site. Dr.
Shapiro successfully participated in earlier Cotara studies and we are
delighted that his center is now participating in the Cotara dosimetry
trial."
"We are pleased to join the dosing and dosimetry trial of Cotara for
the treatment of recurrent GBM," said Dr. William Shapiro, director, neuro
oncology program; Marley chair, neurology; professor of neurology,
University of Arizona College of Medicine; and Cotara principal
investigator at the Barrow Neurological Institute. "GBM is a deadly disease
with very poor survival prospects for relapsed patients, and improved
therapies are urgently needed. We are hopeful that the encouraging survival
trends seen in previous Cotara studies will be replicated in larger trials
going forward, and we view this dosimetry trial as an important step on
that path."
Mr. King continued, "We are also pleased to report that we have
recently added additional clinical sites to the Cotara Phase II study,
increasing the total participating centers from three sites to eight sites.
We anticipate enhanced enrollment rates going forward, particularly in view
of the quality and enthusiasm of the investigators we have recruited. We
look forward to reporting further interim results from the Cotara program
as we achieve additional enrollment milestones in the coming months."
The objectives of the open-label Phase II trial are to confirm the
safety of the selected dose of Cotara and to obtain estimates of overall
patient survival, progression-free survival and the proportion of patients
alive at six months in GBM patients at first relapse. Patients in the trial
are receiving a single infusion of Cotara by convection-enhanced delivery
(CED), a technique that delivers the agent to the tumor with great
precision. Patients receive brain scans at eight-week intervals
post-treatment. Total enrollment in the 40-patient trial has reached the
20% completion mark. Patients who are continuing in the trials are being
monitored for safety and overall survival, with the first dosed patient
having reached eight months of survival post-treatment. Patient screening
for the trial will continue until all 40 patients have been enrolled.
About Cotara(R)
Cotara is an experimental treatment for brain cancer that links a
radioactive isotope to a targeted monoclonal antibody. This monoclonal
antibody is designed to bind to a type of DNA that is exposed only on dead
and dying cells. Solid tumors have many dead and dying cells at their
center. Cotara's targeting mechanism enables it to home in on these cells,
delivering its radioactive "payload" directly to the center of the tumor
mass and thereby destroying it "from the inside out" with minimal radiation
exposure to healthy tissue. Cotara is delivered using convection-enhanced
delivery (CED), which targets the specific tumor site in the brain. In a
previous clinical study, a subset of patients with recurrent glioblastoma
treated with Cotara achieved a median survival of 38 weeks, a 58% increase
over the median survival time of 24 weeks for patients treated with
standard of care therapy. In this study, 25% of 28 recurrent patients
survived for more than a year post-treatment and 10% of patients survived
for more than three years. These data are considered a promising
development in this deadly disease. Cotara has been granted orphan drug
status and fast track designation for the treatment of glioblastoma
multiforme and anaplastic astrocytoma by the U.S. Food and Drug
Administration.
About Peregrine Pharmaceuticals
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a
portfolio of innovative product candidates in clinical trials for the
treatment of cancer and hepatitis C virus (HCV) infection. The company is
pursuing three separate clinical programs in cancer and HCV 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. (http://www.avidbio.com), which provides development
and bio-manufacturing services for both Peregrine and outside customers.
Additional information about Peregrine can be found at
http://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 survival trends will not be
replicated in larger trials and the risk that the company will experience
delays in patient enrollment. 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, 2007 and
the quarterly report on Form 10-Q for the quarter ended January 31, 2008.
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.
Contacts:
GendeLLindheim BioCom Partners
Investors Media
info@peregrineinc.com Barbara Lindheim
(800) 987-8256 (212) 918-4650
SOURCE Peregrine Pharmaceuticals, Inc.
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Related links:
http://www.peregrineinc.com
CONTACT:
Investors, 1-800-987-8256,
info@peregrineinc.com, or Media, Barbara Lindheim,
+1-212-918-4650, both of GendeLLindheim BioCom Partners, for
Peregrine Pharmaceuticals, Inc.
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