ZymoGenetics and Serono Report Detailed Positive Results From Atacicept Phase 1b Clinical Trial in Patients With Lupus
13 November 2006 - 5:00PM
PR Newswire (US)
Clear Biologic Activity, Tolerability and Trends Toward Efficacy
Observed SEATTLE, Washington and GENEVA, Switzerland, November 13
/PRNewswire-FirstCall/ -- ZymoGenetics, Inc. (NASDAQ:ZGEN) and
Serono (virt-x: SEO and NYSE: SRA) today presented positive results
at the American College of Rheumatology (ACR) annual meeting from a
Phase 1b study in systemic lupus erythematosus (SLE) patients
treated with atacicept[1]. The results showed that atacicept was
well tolerated across all dose levels and schedules in the study.
In addition, atacicept therapy was associated with clear biologic
activity, as shown by dose-dependent reductions in several biologic
markers, consistent with atacicept's proposed mechanism of action.
"ZymoGenetics and Serono are striving to develop an effective
therapy for patients who suffer from lupus," said Bruce L.A.
Carter, President and Chief Executive Officer of ZymoGenetics. "We
believe atacicept has the potential to help people with this
debilitating disease." The primary objective of the dose-escalating
Phase 1b clinical trial, which included 49 patients with SLE in 6
cohorts, was to determine the safety and tolerability of atacicept
administered subcutaneously. Secondary objectives included
examining the effects of various dose and schedule regimens on
markers of biologic activity and disease activity. "The Phase 1b
results are very encouraging and we are looking forward to moving
the clinical development of atacicept in patients with SLE to Phase
2," said Franck Latrille, Senior Executive Vice President,
Corporate Global Product Development at Serono. ZymoGenetics and
Serono are 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. Key Study Findings: Clear
biologic activity: Consistent with the mode of action: -
Immunoglobulins showed prompt dose-related decreases with atacicept
treatment. - Among patients treated with the highest study dose of
atacicept (9mg/kg), median IgA, IgG and IgM levels were reduced by
32, 16 and nearly 50 percent relative to baseline. Patients treated
with placebo showed average reductions of only four percent. -
Repeated doses were associated with greater decreases in
immunoglobulin (Ig) levels than single equivalent doses. -
Following treatment cessation, Ig levels returned towards baseline.
- Mature and total B-cells showed a sustained, dose-related
reduction. Tolerability: - No serious adverse events were reported
in patients treated with atacicept. - There was no evidence of
increased infection risk among treated subjects, and no binding
antibodies to atacicept were detected. Positive trend towards
efficacy: - Although the study was not designed to evaluate
efficacy, compared to placebo an overall positive trend in
SELENA-SLEDAI scores[2] and complement levels was seen in patients
treated with multiple doses of atacicept. A separate poster[3]
presented at ACR reviewed findings from a Phase 1b study with
atacicept in patients with rheumatoid arthritis, as announced
earlier this year. The companies are planning to initiate the Phase
2 study with atacicept in RA patients before the end of 2006. About
the Study The double blind, placebo-controlled, dose escalating,
multi-site Phase 1b trial enrolled forty-nine patients with
mild-to-moderate SLE. Six cohorts, consisting of eight patients
each, were treated with either atacicept or placebo. Cohorts 1
through 4 received a single subcutaneous dose of 0.3, 1, 3, or 9
mg/kg of atacicept respectively. Cohorts 5 and 6 received four
weekly doses of 1 mg/kg or 3 mg/kg respectively. Patients were
followed for either six weeks (cohorts 1-4) or nine weeks (cohorts
5-6). All patients were monitored during and for several weeks
after dosing for safety purposes. The primary outcome measure was
the systemic and local tolerability of atacicept administered
subcutaneously. The secondary measures included pharmacokinetics
and pharmacodynamics, as well as measures of SLE disease activity.
Atacicept was well tolerated by patients with SLE at all doses
investigated. There was a clear demonstration of biologic activity
consistent with the mechanism of action of atacicept and positive
trends towards efficacy were observed. Overall, the results
demonstrated a favorable tolerability profile. The predominant
adverse event noted was a mild to moderate local injection site
reaction (redness of skin or pain at the injection site), which was
observed in 50% of atacicept subjects and less frequently in the
placebo and 0.3 mg/kg groups. Few notable differences were observed
between atacicept and placebo in the nature, severity or frequency
of adverse events. 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.
Posters The abstracts and posters are available at
http://www.zymogenetics.com/ in the 'What's New' section on the
home page. Background material For free B-roll, video and other
content for Serono and its products, please visit the Serono Media
Center http://www.thenewsmarket.com/Serono. You can download
print-quality images and receive broadcast-standard video digitally
or by tape from this site. Registration and video is free to the
media. 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$2,586.4
million. 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] Trial of Atacicept in Patients with Systemic
Lupus Erythematosus (SLE) (poster L19/499), ACR/ARHP Poster Session
B Late-Breaking Posters, November 13, 2006, American College of
Rheumatology Annual Meeting [2] SELENA-SLEDAI: SLE Disease Activity
Index; The original SLEDAI is a weighted, cumulative index of lupus
disease activity, and the SELENA SLEDAI represents a further
refinement. [3] A Phase Ib Study to Investigate Atacicept (TACI-Ig)
In Patients With Rheumatoid Arthritis (poster L36/516). ACR/ARHP
Poster Session B Late-Breaking Posters, November 13, 2006, American
College of Rheumatology Annual Meeting DATASOURCE: Serono
International S A CONTACT: For more information, please contact:
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. 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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