Serono Announces Discontinuation of Onercept in Moderate-to-Severe Psoriasis and Canvaxin(TM) in Stage IV Melanoma
April 06 2005 - 2:00AM
PR Newswire (US)
Serono Announces Discontinuation of Onercept in Moderate-to-Severe
Psoriasis and Canvaxin(TM) in Stage IV Melanoma GENEVA, April 5
/PRNewswire-FirstCall/ -- Serono (NYSE: SRA; virt-x: SEO) announced
today the discontinuation of two phase 3 clinical trial programs;
onercept (recombinant tumor necrosis factor binding protein) in
moderate-to-severe psoriasis and Canvaxin(TM) in Stage IV melanoma,
licensed from CancerVax. The decision to discontinue these clinical
trials is based on the recommendations of two separate independent
Data and Safety Monitoring Boards (DSMBs). Onercept in
moderate-to-severe psoriasis In 2004, Serono initiated three phase
3 clinical trials in moderate-to-severe psoriasis. Investigators
have recently reported two patients diagnosed with sepsis, one of
whom subsequently died. Sepsis is a recognized potential risk for
patients treated with anti-tumor necrosis factor (TNF) therapies.
Serono convened a meeting of the independent DSMB to evaluate the
available blinded efficacy data at 12 weeks for the two
placebo-controlled pivotal trials and data from the first 12 weeks
of the open-label trial. It was determined based on these aggregate
data that the efficacy response observed for onercept was less than
that observed in the earlier phase 2 trial, and with other
available treatments. As a consequence of its unfavorable
risk-benefit profile, the DSMB recommended to discontinue the
clinical development of onercept in moderate-to-severe psoriasis.
Canvaxin(TM) in Stage IV melanoma The DSMB for Canvaxin(TM) which
recently completed its planned, second interim analysis of the data
in Stage IV melanoma, recommended its discontinuation as the data
are unlikely to provide significant evidence of a survival benefit
for Canvaxin(TM)-treated patients with Stage IV melanoma versus
those receiving placebo. With regard to the currently on-going
phase 3 clinical trial of Canvaxin(TM) in Stage III melanoma, the
DSMB confirmed that this trial should continue. The third interim
analysis of the data is expected in the third quarter of 2005. The
final analysis of data from this clinical trial will take place
after the required number of clinical events will have occurred,
which is currently estimated to be around mid-2006. "We support the
recommendation of the two Data and Safety Monitoring Boards", said
Franck Latrille, Senior Executive Vice President, Corporate Global
Product Development. "We will continue to develop Canvaxin(TM) in
Stage III melanoma." Conference Call Serono will hold a conference
call on Wednesday, April 6, 2005, starting at 15:00 pm Central
European Time (9:00 am Eastern Time) during which Serono Management
will present a statement on the discontinuation of these clinical
trials and answer questions. To join the telephone conference
please dial +1-866-291-4166 (from the US), 091-610-5600 (from
Switzerland), 0207-107-0611 (from the UK) and +41-91-610-5600 (from
elsewhere). Telephone playback will be available one hour after the
conference call and until 5.00 pm CET on April 15, 2005. To access
this playback please dial the following numbers: 091-612-4330 (from
Switzerland), 0207-108-6233 (from the UK), +1-866-416-2558 (from
the USA) and +41-91-612-4330 (from elsewhere) and enter the PIN
code 943# from a touch tone telephone. About the DSMB The DSMB
consists of independent experts who are not participating in the
clinical trials. Their primary responsibility is to monitor, on a
periodic basis, the data emerging from a clinical trial and to
provide recommendation to the sponsor on whether a study should
continue, be modified or discontinued. 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, 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. 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/
http://www.seronousa.com/ Reuters: SEO.VX / SRA.N Bloomberg: SEO VX
/ SRA US DATASOURCE: Serono International S.A. CONTACT: Corporate
Media Relations: Tel: +41-22-739-36-00, Fax: +41-22-739-30-85;
Media Relations, USA: Tel: +1-781-681-2340, Fax: +1-781-681-2935;
Corporate Investor Relations: Tel: +41-22-739-36-01, Fax:
+41-22-739-30-22; Investor Relations, USA: Tel: +1-781-681-2552,
Fax: +1-781-681-2912
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