Interim Data From Peregrine's Phase II Trial in Second-Line Non-Small Cell Lung Cancer Demonstrate Doubling of Median Overall Survival in Bavitiximab-Containing Arms
TUSTIN, CA -- (Marketwire) -- 09/07/12 --
• Interim Data from Double-Blind, Placebo-Controlled Trial
Presented at Late-Breaking Plenary Session at Leading Oncology
Symposium
• Data Show Statistically Significant Improvement in Overall
Survival for Patients Receiving Bavituximab Plus Docetaxel Versus
Docetaxel Alone
• Clinical Data Strongly Support Advancing Program into Phase
III Clinical Development
• Company to Host Conference Call on Monday, September 10, at
11:00 AM EDT
Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM), today announced
that interim results were presented from its 121 patient
randomized, double-blind, placebo-controlled Phase IIb trial in
patients with refractory non-small cell lung cancer (NSCLC). The
blinded study evaluated two dose levels of bavituximab
(bavituximab-containing arms) given with docetaxel versus docetaxel
plus placebo (control arm). The interim data showed a statistically
significant improvement in overall survival (Hazard Ratio 0.524,
p-value .0154) and a doubling of median overall survival (OS) in
the bavituximab-containing arms compared to the control arm. The
following interim data was presented as part of a late-breaking
plenary presentation at the 2012 Chicago Multidisciplinary
Symposium in Thoracic Oncology by David Gerber, M.D., Associate
Professor of Internal Medicine at the University of Texas
Southwestern Medical Center, a principal investigator in the
trial.
----------------------------------------------------------------------------
Treatment Arm
----------------------------------------------------------------------------
Bavituximab Bavituximab Bavituximab
Placebo (1 mg/kg) (3 mg/kg) (Pooled Data)
plus docetaxel plus docetaxel plus docetaxel plus docetaxel
----------------------------------------------------------------------------
Number of
patients (per
protocol 38 40 39 79
population)
----------------------------------------------------------------------------
Median Overall
Surviva lHazard 5.6 months 11.1 months 13.1 months 12.1 months
Ratio (p-value) -- .512 (.0286) .539 (.0714) .524 (.0154)
----------------------------------------------------------------------------
Overall Response 7.9% 15% 17.9% 16.5%
Ratep-value -- .3262 .1895 .2069
----------------------------------------------------------------------------
Progression Free
Survival Hazard 3.0 months 4.2 months 4.5 months 4.2 months
Ratio (p-value) -- .571 (.0794) .65 (.1921) .605 (.067)
----------------------------------------------------------------------------
"This study was a rigorous trial designed to minimize bias and
we are encouraged that this trial yielded such positive results in
the most important endpoint, overall survival. The positive overall
response rates and progression free survival in both
bavituximab-containing arms seen earlier in the study has now
translated into a statistically significant extension in overall
survival for patients, a result rarely achieved in phase II
clinical trials." said Joseph Shan, vice president of clinical and
regulatory affairs at Peregrine. "The quality of this data gives us
a solid foundation for designing a phase III trial with an
increased probability of success. We are planning for an
end-of-phase II meeting with the FDA as we plan to initiate this
trial by mid-2013."
The trial enrolled 121 patients (117 evaluable per the study
protocol) with second-line non-squamous NSCLC following one prior
chemotherapy regimen at over 40 clinical centers. Patients were
equally randomized to 1 of the 3 treatment arms, docetaxel
(75mg/m2) plus either placebo, 1 mg/kg bavituximab, or 3 mg/kg
bavituximab until disease progression. Approximately 50% of the
patients were enrolled in the U.S. and 50% were enrolled
internationally with equal distribution between all treatment
groups.
"Robust data from this Phase II trial clearly demonstrate a
significant benefit in overall survival with a good safety profile
in patients receiving bavituximab plus docetaxel compared to those
receiving docetaxel plus placebo," said Steven W. King, president
and chief executive officer of Peregrine. "We are currently in
discussions with several potential pharmaceutical partners who have
expressed great interest in our bavituximab oncology program. It is
our goal to identify the optimal partner to assist with the design
and logistics of a multinational Phase III pivotal trial."
The interim results from the study showed no significant safety
differences between the three treatment arms as determined by the
trial's independent data monitoring committee. Baseline
characteristics were well balanced across all three treatment arms
of the study, including performance (ECOG) status, age, gender, and
race. Tumor responses were determined in accordance with Response
Evaluation Criteria In Solid Tumors (RECIST 1.1) based on blinded
central radiology review.
"The median overall survival results from the Proof-of Concept
study are truly outstanding and great news for patients.
Statistically significant overall survival results at this stage of
development are rare and have put us in an excellent position for
advancing the program. Our attention is now turned to an end of
phase II meeting by year end which will help us define the most
efficient path forward to potential regulatory approval," said
Robert Garnick, PhD, head of regulatory affairs at Peregrine. "A
global Phase III trial designed very similarly to the robust design
of this Phase II trial greatly increases bavituximab's likelihood
of success."
Audio Webcast
In conjunction with Dr. Gerber's presentation in Chicago, Peregrine
has posted an audio webcast and slide deck to Peregrine's website.
The webcast will be hosted by Joseph Shan, vice president of
clinical and regulatory affairs. This event will be pre-recorded.
Access to the audio and corresponding slides can be found on
Peregrine's website.
Conference Call
Peregrine will host a conference call and webcast to discuss these
data and financial results for the first quarter fiscal year 2013
on Monday, September 10, 2012, at 11:00 AM ET (8:00 AM PT). To
listen to the conference call, please dial (877) 312-5443 or (253)
237-1126 and request the Peregrine Pharmaceuticals call. A replay
of the call will be available starting approximately two hours
after the conclusion of the call through September 24, 2012 by
calling (855) 859-2056, or (404) 537-3406 and using passcode
27367274.
About Lung Cancer
According to the American Cancer Society, lung cancer is the second
most commonly diagnosed cancer in the U.S., with approximately
226,160 new cases and 160,340 deaths each year, representing
approximately 28% of all cancer deaths. NSCLC is the most common
type of lung cancer, accounting for approximately 85-90% of lung
cancer cases. Unfortunately, the five-year survival rate for NSCLC
patients is only 1%.
About Bavituximab
Bavituximab is a first-in-class phosphatidylserine (PS)-targeting
monoclonal antibody that represents a new approach to treating
cancer. Bavituximab is the lead drug candidate from the company's
PS technology platform and is currently being tested in eight
clinical trials including three randomized Phase II trials in
front-line and second-line non-small cell lung cancer, front-line
pancreatic cancer and five investigator-sponsored trials (ISTs) in
additional oncology indications.
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.
About Peregrine Pharmaceuticals
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with
a portfolio of innovative monoclonal antibodies in clinical trials
focused on the treatment and diagnosis of cancer. The company is
pursuing multiple clinical programs in cancer with its lead product
candidate bavituximab and 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 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 overall survival data together with
the above reported data may not support registration filings with
the U.S. Food and Drug Administration, the risk that overall
survival data from the planned Phase III trial will not be
consistent with the results from the randomized, double-blind,
placebo-controlled Phase IIb trial, the risk that results from the
other randomized Phase II trial will not be consistent with results
experienced in the earlier single-arm Phase II trial or support
registration filings with the FDA, and the risk that Peregrine may
not have or raise adequate financial resources to complete the
planned clinical programs. Factors that could cause actual results
to differ materially or otherwise adversely impact the company's
ability to obtain regulatory approval for its product candidates
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, 2012. 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.
Image Available:
http://www2.marketwire.com/mw/frame_mw?attachid=2086681
Add to Digg Bookmark with del.icio.us Add to Newsvine
Contact:
Christopher Keenan or Jay Carlson
Peregrine Pharmaceuticals, Inc.
(800) 987-8256
info@peregrineinc.com
Source: Peregrine Pharmaceuticals
Posted: September 2012
