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UNITED
STATES
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SECURITIES AND EXCHANGE COMMISSION
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Washington, D.C. 20549
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SCHEDULE 14A
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Proxy
Statement Pursuant to Section 14(a) of
the Securities Exchange Act of 1934 (Amendment No. )
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Preliminary Proxy Statement
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Confidential, for
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Definitive Proxy Statement
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Definitive Additional Materials
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Soliciting Material Pursuant to
§240.14a-12
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SONUS
PHARMACEUTICALS, INC.
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(Name
of Registrant as Specified In Its Charter)
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N/A
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The following is a press
release of OncoGenex Technologies Inc. dated June 2, 2008.
ONCOGENEX REPORTS THAT LOW SERUM CLUSTERIN
LEVELS WERE PREDICTIVE OF SURVIVAL IN PRELIMINARY ANALYSES OF PHASE 2 STUDY OF
LEAD DRUG CANDIDATE OGX-011
Encouraging survival duration continues with
OGX-011 plus second-line chemotherapy for the treatment of prostate cancer;
Data presented at the 2008 Annual Meeting of
the American Society of Clinical Oncology
VANCOUVER,
British Columbia, Canada – June 2, 2008 – OncoGenex
Technologies Inc. announced today that the Company’s lead cancer drug
candidate, OGX-011, continues to show better than expected survival results in
patients with hormone refractory prostate cancer (HRPC) when compared to
published results. OGX-011, also referred to as custirsen
sodium, is a second-generation
antisense oligonucleotide designed to facilitate tumor cell death induced by
chemotherapy by decreasing production of clusterin, a cell survival protein
linked to treatment resistance. Preliminary
analyses have shown that low-average levels of serum clusterin were predictive
of the survival benefit. Additionally, patients
treated with second-line chemotherapy plus OGX-011 experienced a reduction in
pain that was durable as well as a decline in PSA. These data were presented by
Dr. Fred Saad, Professor of Surgery/Urology at the University of Montreal,
on June 1 at the 2008 Annual Meeting of the American Society of Clinical
Oncology. OncoGenex and Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) are
collaborating on development of OGX-011.
The Phase 2
study evaluated 42 patients: 22 patients were treated with mitoxantrone plus
OGX-011 and 20 patients with docetaxel plus OGX-011. While follow up on surviving patients is
still ongoing, the following preliminary findings were reported:
· Survival
continued to be better than expected based on previously published reports: With a median follow-up of 17.2 months
following the start of second-line chemotherapy, approximately 38% of the 42
patients remain alive with a median survival of 12.1 months. Median survival
has been estimated at 11.4 months in the mitoxantrone plus OGX-011 group and
14.7 months in the docetaxel plus OGX-011 group. These data compare favorably
with published results reporting median survivals at approximately 10 months for
HRPC patients receiving second-line chemotherapy.
· Post-treatment
serum clusterin levels were lower compared to baseline levels and the average
serum clusterin levels were predictive of survival in preliminary analyses: Comparison of baseline serum clusterin
levels to the post-treatment average levels showed a significant reduction (p <
0.0001). In addition, average serum clusterin levels were predictive of
survival, with low-average levels predicting median survival time of 14.7
months compared to high-average levels predicting median survival time of 5.5
months. These data suggest that a reduction in clusterin levels may improve
survival.
· Durable
reductions in pain or analgesic use were achieved in patients who entered the
study with pain: Reductions
in pain or analgesic use were seen in 46% of evaluable patients treated with
mitoxantrone plus OGX-011 with a median duration of 5.8 months and in 61% of
evaluable patients retreated with docetaxel plus OGX-011 with a median duration
of 6.2 months. These data are better than expected when compared to the 22-35%
of patients receiving first-line chemotherapy who reported a reduction in pain
in the primary Phase 3 study resulting in the approval of docetaxel (TAX 327
study) that was published in the October 7th, 2004 issue of the
New England Journal of Medicine.
· Both
treatment groups achieved PSA declines of at least 50%: 27% of patients treated with mitoxantrone
plus OGX-011 achieved at least a 50% PSA decline; 40% of patients treated with
docetaxel plus OGX-011 also achieved at least a 50% PSA decline. Decreasing PSA
levels are used by physicians as a measure of a patient’s response to therapy
in prostate cancer.
· More
chemotherapy than expected was safely administered to and tolerated by patients
when OGX-011 was combined with second-line chemotherapy: Patients received a median of 6 cycles of
mitoxantrone plus OGX-011 or 8 cycles of docetaxel plus OGX-011 as second-line
chemotherapy. These data compare favorably with published results where the
median number of cycles that could be administered for second-line chemotherapy
alone was 3 to 4 cycles. Thus OGX-011 treatment was well tolerated and allowed
administration of more chemotherapy for longer treatment duration of metastatic
HRPC.
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This Phase 2 study was designed as an
open-label, randomized, multicenter study evaluating weekly administration of
OGX-011 in combination with second-line chemotherapy in patients with
metastatic hormone refractory prostate cancer who were previously treated with
a minimum of 2 cycles of docetaxel-based first-line chemotherapy. Patients in this study
represented a poor prognostic population due to rapid disease progression
during or within 6 months of completion of first-line docetaxel therapy, with a
median of 0.7 months in the OGX-011 plus mitoxantrone treated group and 1.8
months in the OGX-011 plus docetaxel retreatment group. Because
OGX-011 has been shown to enhance chemotherapy and reverse chemotherapy
resistance in preclinical in vitro
and in vivo models, the primary
objective of this study was to assess the safety and tolerability of OGX-011 in
combination with either mitoxantrone or docetaxel retreatment as second-line
chemotherapy. The secondary objectives were to determine the efficacy of
OGX-011 in combination with second-line chemotherapy in terms of PSA response,
pain progression and survival as well as exploring the relationship between
serum clusterin levels with those parameters. Registration studies are planned
utilizing chemotherapy plus OGX-011 as second-line therapy in patients whose
disease is progressing after a first-line docetaxel regimen.
“These data showed that low serum clusterin
levels were predictive of survival,” said Dr. Fred Saad, who is also the
primary investigator in the study. “The
data also suggests that the combination of OGX-011 with docetaxel or
mitoxantrone may improve survival outcomes and may lead to durable pain
palliation in second-line prostate cancer. Survival and durable pain palliation
are key endpoints for planned clinical trials that will lead to the approval of
new therapeutic alternatives.”
About OGX-011
OGX-011 is
designed to block production of clusterin, a cell survival protein that is
over-produced in several cancer indications and in response to many cancer
treatments, including hormone ablation therapy, chemotherapy and radiation
therapy. Increased clusterin production is observed in many human cancers,
including prostate, non-small cell lung, breast, ovarian, bladder, renal,
pancreatic, anaplastic large cell lymphoma and colon cancers and melanoma.
Increased clusterin production is linked to faster rates of cancer progression,
treatment resistance and shorter survival duration. Clusterin levels may be
further increased in response to standard cancer therapies, including hormone
ablation therapy, chemotherapy and radiation therapy. Clusterin expression is
linked to disease progression, treatment resistance, poor prognosis and
survival in scientific publications. For example, increased expression of
clusterin in prostate cancer is closely correlated with increasing Gleason
score, which is a strong prognostic factor for poor survival of patients with
prostate cancer.
About OncoGenex
OncoGenex is a private biopharmaceutical company committed to
the development and commercialization of new cancer therapies that address
treatment resistance in cancer patients. The company’s three product candidates
are designed to inhibit the production of specific proteins associated with
treatment resistance and which are over-produced in response to a variety of
cancer treatments. OGX-011 is completing evaluation in five Phase 2 clinical
studies in prostate, lung, and breast cancers. OGX-427 has begun evaluation in
Phase 1 clinical studies, while the third product candidate, OGX-225, has
completed preclinical pharmacology studies. More information is available at
www.oncogenex.ca.
Definitive Agreement to Merge
On May 28, 2008, Sonus Pharmaceuticals, Inc.
(NASDAQ: SNUS) and OncoGenex Technologies Inc., jointly announced the signing
of a definitive agreement to merge the two companies. The combined company will
operate as OncoGenex Pharmaceuticals, Inc. The proposed transaction received
unanimous approval from the Boards of Directors of Sonus and OncoGenex, and is
expected to be completed in the third quarter of 2008, subject to regulatory
approval, the approval of Sonus’
and OncoGenex’ shareholders and in the case of OncoGenex, court approval under
the arrangement provisions of the Canada Business Corporations Act.
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Safe Harbor
This press release contains forward-looking statements, including
statements concerning clinical trial results and the proposed merger between
Sonus and OncoGenex. These statements are based on management’s current
expectations and beliefs and are subject to a number of risks, uncertainties
and assumptions that could cause actual results to differ materially from those
described in the forward-looking statements. All statements other than
statements of historical fact are statements that could be deemed
forward-looking statements. For example,
statements of the results of clinical studies, the timing of clinical trials
and development efforts and the timing of closing the proposed merger are all
forward-looking statements. The
potential risks and uncertainties include, among others, that clinical results
will not be maintained in final data analysis, that current or future clinical
trials will not be successful or confirm the results of earlier studies, risks
related to the timing and costs of clinical trials and regulatory approvals,
risks associated with obtaining funding from third parties or completing a
financing necessary to support the costs and expenses of clinical studies,
risks relating to the development, safety and efficacy of therapeutic drugs and
potential applications for these products and the possibility that the merger
with Sonus does not close or that the closing may be delayed. No assurances can be given that any of the
events anticipated by the forward-looking statements will transpire or occur,
or if any of them do so, what impact they will have on the results of
operations or financial condition of OncoGenex. The Company undertakes no
obligation to update the forward-looking statements contained herein or to
reflect events or circumstances occurring after the date hereof.
Proxy Solicitation
In connection with the proposed merger, Sonus intends to file with the
SEC a Proxy Statement and related materials and to mail to its stockholders the
final Proxy Statement containing information about Sonus, OncoGenex and the
proposed merger. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE PROXY
STATEMENT AND THE OTHER RELEVANT MATERIALS, CAREFULLY AND IN THEIR ENTIRETY,
WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION
ABOUT SONUS, ONCOGENEX AND THE PROPOSED MERGER.
Sonus and OncoGenex, and certain of their directors, executive officers
and other members of management and employees may be deemed to be participants
in the solicitation of proxies in connection with the proposed transaction. Information about the directors and executive
officers of Sonus, including their respective security holdings, is set forth
in Sonus’ Amendment No. 1 to Form 10-K for the fiscal year ended December 31,
2007, filed with the Securities and Exchange Commission on April 29,
2008. As of May 27, 2008, OncoGenex’
directors and executive officers beneficially owned approximately 1,755,000
shares, or 14.5%, of OncoGenex’ capital stock. Investors may obtain additional
information regarding the interests of OncoGenex, Sonus and their respective executive
officers and directors in the merger by reading the Proxy Statement for such
proposed transaction when it becomes available.
The Proxy Statement and other relevant materials, when they become
available, and any other documents filed by Sonus with the SEC, may be obtained
free of charge at the SEC’s web site at www.sec.gov. In addition, investors and security holders
may obtain free copies of the documents, when they are available, filed with
the SEC by Sonus by directing a request to: Sonus Pharmaceuticals, Inc.,
1522 217th Place SE, Suite 100, Bothell, WA 98021, Phone (425) 686-1500,
Fax (425) 686-1600, Attention: Investor Relations.
###
OncoGenex
Media and Investor Contact:
Jason I. Spark
Porter Novelli
Life Sciences
619-849-6005
jspark@pnlifesciences.com
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