Serono: Data And Safety Monitoring Board Recommends Discontinuation of Canvaxin(TM) Phase 3 Clinical Trial for Patients With Sta
October 03 2005 - 6:30PM
PR Newswire (US)
GENEVA, Switzerland and CARLSBAD, California, October 3
/PRNewswire-FirstCall/ -- Serono (virt-x: SEO and NYSE: SRA) and
CancerVax Corporation (NASDAQ:CNVX) announced today their decision
to discontinue the Phase 3 clinical trial of Canvaxin(TM) in
patients with Stage III melanoma based upon the recommendation of
the independent Data and Safety Monitoring Board (DSMB), which
recently completed its planned, third, interim analysis of the data
from this study. The DSMB found that the data are unlikely to
provide significant evidence of an overall survival benefit for
patients with Stage III melanoma who were treated with Canvaxin(TM)
versus those who received placebo. "This news is particularly
disappointing because we understand the devastating impact of this
disease on patients with advanced-stage melanoma, as well as their
families and friends. We are extremely grateful for the strong
support we have received for this clinical trial from the
clinicians, nurses, study coordinators and, especially, the
patients who participated in this clinical trial," said David F.
Hale, President and CEO of CancerVax Corporation. "We will
discontinue all further development and manufacturing operations
for Canvaxin(TM), but we currently plan to continue to further the
development of the other product candidates in our product
pipeline, which we believe hold promise for the treatment of
patients with cancer." "The Phase 2 results were promising, and we
were thus hopeful that this highly innovative product would be
successful in a Phase 3 clinical trial in patients with Stage III
melanoma," said Franck Latrille, Senior Executive Vice President,
Corporate Global Product Development of Serono. "We continue to
have a strong pipeline with five Phase 3 programs and significant
newsflow expected in the next year. Serono remains committed to
oncology with Humax-CD4, adecatumumab and TACI-Ig with study
results from all three programs expected in 2006." There were no
significant safety issues identified with either the Phase 3
clinical trial of Canvaxin(TM) in patients with Stage III melanoma,
or with the Phase 3 clinical trial of Canvaxin(TM) in patients with
Stage IV melanoma, which was discontinued earlier this year. The
recommendations to close both of these clinical trials were not
made because of any potential safety concerns. Once the data from
these clinical trials are fully analyzed, they will be presented at
appropriate scientific meetings. About the DSMB and Interim
Analyses The DSMB consists of independent experts in medical and
surgical oncology, statistics and medical ethics who are not
participating in the clinical trials, whose primary responsibility
is to monitor, on a periodic basis, the data emerging from a
clinical trial and to provide recommendations to the sponsor on
whether a study should be modified or discontinued. About Serono
Serono is a global biotechnology leader. The Company has eight
biotechnology products, Rebif(R), Gonal-f(R), Luveris(R),
Ovidrel(R) /Ovitrelle(R), Serostim(R), Saizen(R), Zorbtive(TM) and
Raptiva(R). In addition to being the world leader in reproductive
health, Serono has strong market positions in neurology, metabolism
and growth and has recently entered the psoriasis area. The
Company's research programs are focused on growing these businesses
and on establishing new therapeutic areas, including oncology.
Currently, there are approximately 30 ongoing development projects.
In 2004, Serono achieved worldwide revenues of US$2,458.1 million,
and a net income of US$494.2 million, making it the third largest
biotech company in the world. Its products are sold in over 90
countries. Bearer shares of Serono S.A., the holding company, are
traded on the virt-x (SEO) and its American Depositary Shares are
traded on the New York Stock Exchange (SRA). http://www.serono.com/
About CancerVax Corporation (http://www.cancervax.com/) CancerVax
Corporation is a biotechnology company focused on the research,
development and commercialization of novel biological products for
the treatment and control of cancer. CancerVax has been evaluating
Canvaxin(TM) in a Phase 3 clinical trial for the treatment of
patients with Stage III melanoma in collaboration with Serono.
CancerVax also has a pipeline of product candidates and
technologies that are being developed for the potential treatment
of cancer. These include SAI-EGF, a product candidate that targets
the epidermal growth factor (EGF) receptor signaling pathway; and
D93, CancerVax's lead anti-angiogenic humanized monoclonal
antibody. CancerVax plans to file an Investigational New Drug (IND)
application for clinical trials of D93 in early 2006, and to
initiate a clinical trial with SAI-EGF in patients with advanced
non-small-cell lung cancer in 2006. CANCERVAX CORPORATION
CONFERENCE CALL AND WEBCAST TUESDAY, OCTOBER 4, AT 9:00 EASTERN
TIME CancerVax management will host a conference call on Tuesday,
October 4, at 9:00 a.m. Eastern Time to discuss the DSMB
recommendation to discontinue the Canvaxin Phase 3 clinical trial
for patients with Stage III melanoma. A live audio webcast of
management's presentation will be available at
http://ir.cancervax.com/. Alternatively, callers may participate in
the conference call by dialing (866)-831-6270 (domestic) or
+1-(617)-213-8858 (international). The passcode is 70660579. A
replay of the conference call can be accessed by dialing (888)
286-8010 (domestic) or +1-(617)-801-6888 (international). The
passcode for the replay is 42654318. The webcast will also be
archived on CancerVax's website. Forward-Looking Statements Serono
Some of the statements in this press release are forward looking.
Such statements are inherently subject to known and unknown risks,
uncertainties and other factors that may cause actual results,
performance or achievements of Serono S.A. and affiliates to be
materially different from those expected or anticipated in the
forward-looking statements. Forward-looking statements are based on
Serono's current expectations and assumptions, which may be
affected by a number of factors, including those discussed in this
press release and more fully described in Serono's Annual Report on
Form 20-F filed with the U.S. Securities and Exchange Commission on
March 16, 2005. These factors include any failure or delay in
Serono's ability to develop new products, any failure to receive
anticipated regulatory approvals, any problems in commercializing
current products as a result of competition or other factors, our
ability to obtain reimbursement coverage for our products, the
outcome of government investigations and litigation and government
regulations limiting our ability to sell our products. Serono has
no responsibility to update the forward-looking statements
contained in this press release to reflect events or circumstances
occurring after the date of this press release. CancerVax
Corporation CancerVax cautions you that statements included in this
press release that are not a description of historical facts are
forward-looking statements. For example, statements about the
timing of the initiation of clinical trials with any of CancerVax's
product candidates, and plans and objectives of management, are all
forward-looking statements. The inclusion of forward-looking
statements should not be regarded as a representation by CancerVax
that any of its plans will be achieved. Actual results may differ
materially from those set forth in this release due to the risks
and uncertainties inherent in CancerVax's business including,
without limitation: the progress, timing and outcome of its
clinical trials; its ability to obtain additional financing to
support its operations, which could adversely affect its ability to
continue to operate as a going concern; the risk that the
collaboration agreement for Canvaxin(TM) may be terminated by
Serono in certain instances; the risk that CancerVax may be
required to pre-pay the debt incurred to expand its manufacturing
capacity prior to the termination of the loan because of a failure
to comply with covenants included in the loan agreement; unexpected
adverse side effects or inadequate therapeutic efficacy of its
product candidates that could delay or prevent product development
or commercialization, or that could result in recalls or product
liability claims; competition from other pharmaceutical or
biotechnology companies; CancerVax's limited experience in
manufacturing and testing biological products, which may result in
delayed development or commercialization of its product candidates,
as well as lost revenue; and other risks detailed in CancerVax's
Securities and Exchange Commission filings, including CancerVax's
Annual Report on Form 10-K for the fiscal year ended December 31,
2004, and Quarterly Report for the fiscal quarter ended June 30,
2005. You are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof.
All forward-looking statements are qualified in their entirety by
this cautionary statement and CancerVax undertakes no obligation to
revise or update this news release to reflect events or
circumstances after the date hereof. This caution is made under the
safe harbor provisions of the Private Securities Litigation Reform
Act of 1995. CancerVax(R) is a registered trademark of CancerVax
Corporation. Canvaxin(TM) is a trademark of CancerVax Corporation.
DATASOURCE: Serono International S.A. CONTACT: For more
information, please contact: Serono - Corporate Media Relations:
Tel: +41-22-739-36-00, Fax: +41-22-739-30-85,
http://www.serono.com/ . Media Relations, USA: Tel:
+1-781-681-2340, Fax: +1-781-681-2935, http://www.seronousa.com/ .
Corporate Investor Relations: Tel: +41-22-739-36-01, Fax:
+41-22-739-30-22, Reuters: SEO.VX / SRA.N. Bloomberg: SEO VX / SRA
US. Investor Relations, USA: Tel: +1-781-681-2552, Fax:
+1-781-681-2912. CancerVax Contact: William R. La Rue, CancerVax
Corporation, Chief Financial Officer, +1-760-494-4200,
http://www.cancervax.com/
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