ZymoGenetics and Serono Begin Phase 2 Clinical Trial With Atacicept in Rheumatoid Arthritis
December 20 2006 - 1:00AM
PR Newswire (US)
SEATTLE, Washington and GENEVA, Switzerland, December 20
/PRNewswire-FirstCall/ -- ZymoGenetics, Inc. (NASDAQ:ZGEN) and
Serono (virt-x: SEO and NYSE: SRA) today announced the start of a
Phase 2 clinical trial in which atacicept therapy will be evaluated
in patients with rheumatoid arthritis (RA). The randomized,
double-blind, multi-center study will investigate the efficacy of
atacicept in patients with an inadequate response to prior
treatment with TNF inhibitors. The efficacy of atacicept will be
evaluated according to the American College of Rheumatology (ACR)
criteria for defining clinical improvement in RA patients. "Data
from our Phase 1b RA study indicate that atacicept has potential as
a treatment for rheumatoid arthritis," said Bruce L. A. Carter,
Ph.D., President and Chief Executive Officer of ZymoGenetics. "A
clear patient need still exists for new therapies. The Phase 2
study should provide a clear signal as to the efficacy of atacicept
and this will enable us to make an informed decision about
targeting the RA market with atacicept." "This Phase 2 study is
part of a broad Phase 2 clinical trial program in rheumatoid
arthritis. It also marks an important step toward bringing
innovative treatments to patients whose medical needs are unmet by
current therapies," said Franck Latrille, Senior Executive Vice
President, Corporate Global Product Development at Serono. The
study will enroll 320 patients who have had active RA for more than
one year and who have had an inadequate response to at least 3
months of TNF inhibitor therapy. Patients will be randomized into
groups receiving one of three dose levels (25 mg, 75 mg or 150 mg)
of atacicept or placebo, in addition to background methotrexate
therapy, and they will be treated for twenty-five weeks. Loading
doses will be given twice weekly for 4 weeks, followed by 21 weekly
maintenance doses. A follow-up visit will occur 13 weeks after the
last dose. The primary endpoint will be the rate of ACR 20
response[1] at week 26. Secondary objectives include further
characterizing the efficacy, safety, tolerability and pharmacologic
profile of atacicept at each of these dose levels. ACR 50 and 70
responses and DAS 28[2] will be used as secondary measures of
efficacy. ZymoGenetics and Serono are also in dialogue with the FDA
regarding the SLE Phase 2 clinical development program. The
companies are planning to initiate the trial in SLE in mid-2007.
Earlier this year, the companies completed Phase 1b studies with
atacicept in systemic lupus erythematosus (SLE) and rheumatoid
arthritis. About Atacicept ZymoGenetics and Serono are developing
atacicept (formerly referred to as TACI-Ig) for the treatment of
autoimmune diseases and B-cell malignancies. Atacicept contains the
soluble TACI receptor that binds to the cytokines BLyS and APRIL.
These cytokines, in turn, are members of the tumor necrosis factor
(TNF) family that promote B-cell survival and autoantibody
production associated with certain autoimmune diseases such as
systemic lupus erythematosus (SLE). Current data indicates that
levels of BLyS and APRIL are elevated in patients with rheumatoid
arthritis, SLE and B-cell malignancies. Atacicept has been shown to
affect several stages of B-cell development and may inhibit the
survival of cells responsible for making antibodies. Background
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Forward-looking Statements For ZymoGenetics This press release
contains "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995. These
forward-looking statements are based on the current intent and
expectations of the management of ZymoGenetics. These statements
are not guarantees of future performance and involve risks and
uncertainties that are difficult to predict. ZymoGenetics' actual
results and the timing and outcome of events may differ materially
from those expressed in or implied by the forward-looking
statements because of risks associated with our unproven discovery
strategy, preclinical and clinical development, regulatory
oversight, intellectual property claims and litigation and other
risks detailed in the company's public filings with the Securities
and Exchange Commission, including the company's Annual Report on
Form 10-K for the year ended December 31, 2005. Except as required
by law, ZymoGenetics undertakes no obligation to update any
forward-looking or other statements in this press release, whether
as a result of new information, future events or otherwise. For
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 February 28, 2006. 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. About ZymoGenetics ZymoGenetics creates
novel protein drugs with the potential to significantly help
patients fight their diseases. The Company is developing a diverse
pipeline of potential proprietary product candidates that are
moving into and through clinical development. These candidates span
a wide array of clinical opportunities that include bleeding,
autoimmune diseases and cancer. ZymoGenetics intends to
commercialize these product candidates through internal
development, collaborations with partners, and out-licensing of
patents from its extensive patent portfolio. For further
information, visit http://www.zymogenetics.com/. 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 and
autoimmune diseases. In 2005, Serono, whose products are sold in
over 90 countries, achieved worldwide revenues of US $2.6 billion.
Reported net loss in 2005 was US$106.1 million, reflecting a charge
of US$725 million taken relating to the settlement of the US
Attorney's Office investigation of Serostim. Excluding this charge
as well as other non-recurring items, adjusted net income grew
28.4% to US$565.3 million in 2005. 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). [1] ACR 20 response = the percentage of patients
who achieve at least a 20% improvement in the ACR-specified
measures of disease activity [2] DAS = Disease Activity Score; a
measure of the activity of rheumatoid arthritis DATASOURCE: Serono
International S A CONTACT: For more information, please contact:
Serono, Corporate Media, Relations: Tel: +41-22-414-36-00, Fax:
+41-22-414-30-85, 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:
+41-22-414-36-01, Fax: +41-22-414-30-22, Reuters: SEO.VX / SRA.N,
Bloomberg: SEO VX / SRA US. Investor Relations, USA: Tel:
+1-781-681-2552, Fax: +1-781-681-2912. ZymoGenetics: Investor
Relations John Calhoun, MD, MBA, Director, Corporate Communications
& Investor, Relations, +1-(206)-442-6744. Media Relations,
Susan W. Specht, MBA, Associate Director, Corporate Communications,
+1-(206)-442-6592
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