UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the
Securities
Exchange Act of 1934
Date of
Report (Date of earliest event reported): June 4, 2010
PEREGRINE PHARMACEUTICALS,
INC.
(Exact
name of registrant as specified in its charter)
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Delaware
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0-17085
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95-3698422
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(State
of other jurisdiction of
incorporation)
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(Commission
File Number)
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(IRS
Company Identification
No.)
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14282
Franklin Avenue, Tustin, California 92780
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(Address
of Principal Executive Offices)
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Registrant’s
telephone number, including area code: (714)
508-6000
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Not
Applicable
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(Former
name or former address, if changed since last
report)
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Check the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions (see General Instruction A.2 below):
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o Written communications
pursuant to Rule 425 under the Securities Act (17 CFR
230.425).
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o Soliciting material
pursuant to Rule 14A-12 under the Exchange Act (17 CFR
240.14a-12)
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o Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR.14d-2(b))
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o Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
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Item
8.01 Other
Events.
On June
4, 2010, Peregrine Pharmaceuticals, Inc. issued a press release announcing
clinical trial data results from a Phase II trial evaluating bavituximab in
combination with paclitaxel and carboplatin in patients with front-line
non-small cell lung cancer.
A copy of
the press release is attached to this current report on Form 8-K as Exhibit
99.1.
Item
9.01 Financial
Statements and Exhibits
(d) Exhibits. The
following material is filed as an exhibit to this Current Report on Form
8-K:
| Exhibit Number | Description | |
| 99.1 | Press Release issued June 4, 2010 |
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
| PEREGRINE PHARMACEUTICALS, INC. | |||
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Date:
June 4, 2010
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By:
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/s/ Paul J. Lytle | |
| Paul J. Lytle | |||
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Chief
Financial Officer and Corporate
Secretary
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EXHIBIT
INDEX
| Exhibit Number | Description | |
| 99.1 | Press Release issued June 4, 2010 |
EXHIBIT
99.1
Contact:
Amy
Figueroa
Peregrine
Pharmaceuticals
info@peregrineinc.com
(800)
987-8256
POSITIVE
PHASE II LUNG CANCER DATA TO BE PRESENTED AT ASCO
SUPPORT
RECENTLY OPENED REGISTRATIONAL PHASE IIB TRIAL FOR BAVITUXIMAB
--
43% Objective Tumor Response, 6.1 Months PFS for Front-Line Non-Small
Cell
Lung
Cancer Patients Treated with Bavituximab and Paclitaxel/Carboplatin
- --
TUSTIN, Calif., June 4, 2010
- -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), a clinical-stage
biopharmaceutical company developing innovative monoclonal antibodies for the
treatment of cancer and viral infections, today announced positive data from a
Phase II clinical trial treating front-line non-small cell lung cancer (NSCLC)
patients with bavituximab in combination with paclitaxel and
carboplatin. 43% (21 of 49 patients) of patients achieved an
objective tumor response. Median progression-free survival
(PFS) was 6.1 months and median overall survival will be reported once these
data mature. These results are superior to data showing an objective response
rate of 19% in a similar patient population receiving the same treatment regimen
of carboplatin and paclitaxel alone from the published study upon which
Peregrine’s trial was based. Peregrine’s Phase II data will be
highlighted in a poster presentation on June 6, 2010 at the ASCO Annual
Meeting.
Peregrine’s
registrational Phase IIb trial in refractory NSCLC is open for patient
enrollment, with a second randomized Phase IIb trial in front-line NSCLC planned
to begin by mid-year. For additional information on this randomized,
double-blinded, placebo-controlled trial, visit www.clinicaltrials.gov/ct2/search
and type in the key word “bavituximab.”
“The
objective response and median PFS data from bavituximab in combination with
chemotherapy are very encouraging, as this response rate is more than double the
typical response observed with chemotherapy alone,” commented Raghunadharao
Digumarti, M.D., professor and head of the Department of Medical Oncology at
Nizam’s Institute of Medical Sciences, Hyderabad India. “There is an
urgent need for new therapies that may extend patient survival for this
aggressive, prevalent form of cancer. Bavituximab’s broad-spectrum
potential, demonstrated by promising clinical data in this patient setting and
use in various combination therapy applications, support further development of
this novel monoclonal antibody for cancer.”
Bavituximab
is a first-in-class phosphatidylserine (PS)-targeting monoclonal antibody that
represents a new approach to treating cancer. 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
the Phase II Trial
In
Peregrine’s Phase II trial assessing bavituximab in combination with paclitaxel
and carboplatin, 43% (21 of 49 patients) of patients achieved an objective tumor
response. Median PFS in the trial was 6.1 months and median overall
survival will be reported once these data mature. 73% (36 of 49
patients) of the patients enrolled in this study had Stage IV disease. These
results compare favorably to data from a separate published study showing an
objective response rate of 19% and a median time to progression of 4.2 months in
a similar patient population receiving carboplatin and paclitaxel
alone.
Peregrine’s
multi-center, open-label Phase Il NSCLC trial was designed to assess overall
response rates to bavituximab combined with the front-line standard of care
chemotherapy regimen of carboplatin and paclitaxel. Secondary
objectives of the study included measuring progression-free survival, duration
of response, overall patient survival and safety parameters. Patients
in the study were evaluated regularly for tumor response according to RECIST
criteria.
About
Lung Cancer
Lung
cancer is the leading cause of cancer death. According to the American Cancer
Society, lung cancer is the second most commonly diagnosed cancer, with
approximately 219,440 new cases and 159,000 deaths reported in 2009 in the U.S.
alone. NSCLC is the most common type of lung cancer, accounting for
approximately 85-90% of lung cancer cases. The five-year survival
rate for NSCLC patients is only 1%.
Poster
at ASCO - Sunday, June 6, 2010, 8:00 – 12:00 pm CT
Phase II study of bavituximab plus
paclitaxel and carboplatin in untreated locally advanced or metastatic non-small
cell lung cancer: Interim results (Abstract #7589),
Author: Raghunadharao Digumarti, Poster Board 40H, S Hall A2
Peregrine
will also have a booth (#19114) for the duration of the 2010 ASCO Annual
Meeting.
For more
information on the ASCO conference, visit http://chicago2010.asco.org/Home.aspx.
About
Peregrine Pharmaceuticals
Peregrine
Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company with a
portfolio of innovative monoclonal antibodies in development for the treatment
of cancer and serious viral infections. The company is pursuing three
separate clinical programs in cancer and HCV infection with its lead product
candidates bavituximab and Cotara®. 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 results from larger clinical trials will not be consistent with
results experienced in earlier clinical trials and preclinical studies, the risk
that the company may experience delays in patient enrollment for the planned
phase IIb clinical trials, and risk that results may not support registration
filings with the U.S. Food and Drug Administration. 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, 2009 and
the quarterly report on Form 10-Q for the quarter ended January 31, 2010. 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.
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