Crescendo Bioscience to Present Multiple Studies at 2014 EULAR Meeting
June 10 2014 - 4:05PM
Vectra® DA Identified Patients in
SWEFOT Clinical Study at Higher Risk of Joint Damage
Crescendo Bioscience, a wholly-owned subsidiary of Myriad Genetics,
Inc. (Nasdaq:MYGN), today announced that Vectra® DA data will be
featured in eight posters at the 2014 European League Against
Rheumatism (EULAR) Annual Meeting, June 11–14, 2014, in Paris,
France. Vectra DA is a quantitative, objective multi-biomarker test
to measure disease activity in patients with rheumatoid arthritis
(RA). The Vectra DA test offers insight into the biological
processes that drive disease activity to help rheumatologists
manage RA and improve patient care.
At EULAR, data will be presented by researchers from the Swedish
Farmacotherapy (SWEFOT) clinical trial that demonstrate the
clinical utility of Vectra DA in assessing the risk of future joint
damage at multiple points in time. Additionally, SWEFOT data
indicate that changes in Vectra DA scores were associated with
favorable response to both non-biologic and biologic therapies.
Further, the data demonstrate that Vectra DA may have the potential
to serve as an inclusion criterion for assessing patients who are
candidates for clinical trials in rheumatoid arthritis.
"The breadth of data presented at EULAR is representative of the
clinical utility of Vectra DA in the overall management of RA,"
said Oscar Segurado, chief medical officer at Crescendo Bioscience.
"Vectra DA provides physicians with important, actionable insight
to better assess risk of radiographic progression as well as manage
therapy decisions in their patients with a precise and standardized
tool. The EULAR data also point out the opportunity to identify
more patients that may be eligible to participate in clinical
trials."
The data to be presented at this EULAR meeting will build on a
recently published study in the journal Annals of Rheumatic
Diseases that demonstrated that Vectra DA scores at the start of
the SWEFOT clinical study predicted radiographic progression of
joint damage over the following year. The new data from the SWEFOT
study being presented at EULAR demonstrate that Vectra DA scores at
3 months and 12 months also were predictive of subsequent
radiographic progression over the following 2 years. Additionally,
patients in the SWEFOT study who did not respond to 3 months of
initial methotrexate therapy were randomized to receive either
non-biological DMARD triple therapy or anti-TNF (infliximab)
therapy. Patients with a high Vectra DA score at baseline that
remained high following therapy were at a high risk for
radiographic progression. By contrast, risk for progression was
significantly lower among patients with a high Vectra DA score at
baseline, but lower Vectra DA score following treatment. At all
measured time points, low Vectra DA scores were associated with low
risk for subsequent radiographic progression.
"These are clinically relevant findings for rheumatologists
taking care of patients with RA," said Ronald F. van Vollenhoven,
M.D., Ph.D, Department of Medicine, Karolinska Institute in
Stockholm, Sweden. "These data show that Vectra DA may help
identify those patients at higher and lower risks for radiographic
progression while receiving antirheumatic therapy."
Poster Tour
Presentations |
Title: |
Using the multi-biomarker disease activity
score as a complementary inclusion criterion for clinical trials in
rheumatoid arthritis may enhance recruitment. |
Presenter: |
Ronald van Vollenhoven |
Date: |
Presentation: June 13, 2014 12:00 PM, Room
251 Poster: June 14, 2014; 10:15 AM, Poster Area D, Level 4
Key Finding: In this analysis of the SWEFOT study,
Vectra DA was found to be potentially useful as an inclusion
criterion in clinical trials. Recruitment for clinical trials in
patients with active RA may be enhanced by including patients with
a Vectra DA score > 44 in addition to the conventional approach
of only using patients with a CRP > 10 mg/L. This enhancement
was achieved with a comparable response to treatment and subsequent
radiographic progression. In this study the number of eligible
DMARD naïve patients increased by 24 percent and the number of
eligible MTX Non-responder patients increased by 47 percent. |
Title: |
Multi-biomarker disease activity (Vectra DA
algorithm) score is associated with power doppler ultrasound in
patients with rheumatoid arthritis in low disease activity state:
The Remira Cohort. |
Presenter: |
Margaret H. Ma |
Date: |
Presentation: June 12, 2014; 12:00 PM; Level
2 Paris Room Poster: June 14, 2014; 10:15 AM, Poster Area D, Level
4 Key Finding: Vectra DA can detect joint
inflammation despite the lack of clinical disease activity in RA
patients. Among patients who had low clinical disease activity or
were in remission, Vectra DA algorithm score correlated with the
amount of joint inflammation (synovitis) detected by ultrasound
imaging of joints. |
Title: |
A multi-biomarker disease activity blood test
in patients with juvenile idiopathic arthritis (JIA). |
Presenter: |
Kunihiro Yamaoka |
Date: |
Presentation: June 12, 2014; 12:00 PM; Room
251 Poster: June 13, 2014; 11:45 AM, Poster Area D, Level 4
Key Finding: Researchers found a significant
association between the multi-biomarker disease activity score and
clinical disease activity in patients with juvenile
arthritis. Further assessment of the clinical value of a
multi-biomarker disease activity test for JIA is warranted. |
Poster
Presentations |
Title: |
In early RA, the multi-biomarker disease
activity score at different time-points is predictive of subsequent
radiographic progression. |
Presenter: |
Karen Hambardzumyan |
Date: |
June 14, 2014; 10:15 AM; Poster Area D, Level
4 Key Finding: This SWEFOT study found that
Vectra DA scores at baseline and changes over time were predictive
of radiographic progression for up to two years. These
results, along with data recently published online in the Annals of
Rheumatic Disease, further validate the finding that low/high
scores of Vectra DA are associated with less/more joint damage over
time. |
Title: |
In early RA patients with non-response to
methotrexate the change in multi-biomarker disease activity score
is differentially associated with subsequent response to
non-biological versus biological therapy. |
Presenter: |
Karen Hambardzumyan |
Date: |
June 13, 2014; 11:45 AM; Poster Area D, Level
4 Key Finding: This SWEFOT study suggests
that changes in the Vectra DA score may help guide subsequent
therapy. In DMARD-naïve patients who had inadequate responses
to 3 months of methotrexate, the changes in Vectra DA score at
month 3 were associated with the likelihood of having a subsequent
response to either anti-TNF or triple (DMARD) therapy. |
Title: |
Validation of a multi-biomarker disease
activity score in rheumatoid arthritis in relation to imaging
inflammation and damage. |
Presenter: |
Simon Krabbe |
Date: |
June 13, 2014; 11:45 AM, Poster Area D, Level
4 Key Finding: Vectra DA correlated with
imaging measures of joint inflammation and joint damage, providing
further evidence that the test is associated with biological
processes of disease in RA joints. |
Title: |
Residual inflammatory activity assessed by a
multi-biomarker disease activity blood test is linked to structural
damage in RA patients in low disease activity/remission and normal
C-reactivity protein level. |
Presenter: |
Georg Schett |
Date: |
June 12, 2014; 11:45 AM, Poster Area D, Level
4 Key Finding: In RA patients who were in
clinical remission or low clinical disease activity, Vectra DA was
found to correlate with erosive damage in joints, as detected by
imaging with high-resolution CT scanning, suggesting that the
inflammatory mediators measured by Vectra DA are linked to
structural bone damage in RA. |
Title: |
Effects of tofacitinib treatment on leptin
and other components of the multi-biomarker disease activity score
in patients with rheumatoid arthritis. |
Presenter: |
Kunihiro Yamaoka |
Date: |
June 13, 2014; 11:45 AM, Poster Area D, Level
4 Key Finding: Using Vectra DA to evaluate
treatment response in a clinical trial of the biologic agent
tofacitinib, researchers found that the biomarker leptin increased
with active treatment. |
About Vectra DA
Vectra DA is the only multi-biomarker blood test for rheumatoid
arthritis (RA) disease activity that integrates the concentrations
of 12 serum proteins associated with RA disease activity into a
single objective score, on a scale of 1 to 100, to help physicians
make more informed treatment decisions. Vectra DA testing is
performed at the Crescendo Bioscience state-of-the-art CLIA
(Clinical Laboratory Improvement Amendments) facility. Test results
are reported to the physician 5 to 7 days from shipping of the
specimen to Crescendo Bioscience. Physicians can receive test
results via standard mail, by fax or via the private web portal,
VectraView. For more information on Vectra DA, please visit,
www.Vectra-DA.com.
About Crescendo Bioscience
Crescendo Bioscience, a wholly-owned subsidiary of Myriad
Genetics, Inc., is a molecular diagnostics company dedicated to
developing and commercializing quantitative blood tests for
rheumatoid arthritis (RA) and other autoimmune diseases, located in
South San Francisco, California. Crescendo Bioscience
develops quantitative, objective, reproducible blood tests to
provide rheumatologists with deeper clinical insight to help enable
more effective management of patients with autoimmune and
inflammatory diseases. For more information, please visit the
company website at: www.CrescendoBio.com.
About Myriad Genetics
Myriad Genetics is a leading molecular diagnostic company
dedicated to making a difference in patients' lives through the
discovery and commercialization of transformative tests to assess a
person's risk of developing disease, guide treatment decisions and
assess risk of disease progression and recurrence. Myriad's
molecular diagnostic tests are based on an understanding of the
role genes play in human disease and were developed with a
commitment to improving an individual's decision making process for
monitoring and treating disease. Myriad is focused on strategic
directives to introduce new products, including companion
diagnostics, as well as expanding internationally. For more
information on how Myriad is making a difference, please visit the
Company's website: www.myriad.com.
Myriad, the Myriad logo, Prolaris, Myriad myPath, Myriad myPlan,
Myriad myRisk and Vectra are trademarks or registered trademarks of
Myriad Genetics, Inc. in the United States and foreign countries.
MYGN-F, MYGN-G.
Safe Harbor Statement
This press release contains "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of
1995, including statements relating to the Vectra DA clinical study
data to be presented at the 2014 European League Against Rheumatism
(EULAR) Annual Meeting, June 11–14, 2014, in Paris,
France; the significant clinical value of Vectra
DA, which may help doctors manage patients based on their risk of
disease progression; the effectiveness of Vectra DA testing to
objectively predict disease progression in patients newly diagnosed
with rheumatoid arthritis (RA); and the Company's strategic
directives under the captions "About Vectra DA," "About Crescendo
Bioscience" and "About Myriad Genetics." These
"forward-looking statements" are management's present expectations
of future events and are subject to a number of risks and
uncertainties that could cause actual results to differ materially
and adversely from those described in the forward-looking
statements. These risks include, but are not limited to: the
risk that sales and profit margins of our existing molecular
diagnostic tests and companion diagnostic services may decline or
will not continue to increase at historical rates; risks related to
changes in the governmental or private insurers reimbursement
levels for our tests; the risk that we may be unable to develop or
achieve commercial success for additional molecular diagnostic
tests and companion diagnostic services in a timely manner, or at
all; the risk that we may not successfully develop new markets for
our molecular diagnostic tests and companion diagnostic services,
including our ability to successfully generate revenue outside the
United States; the risk that licenses to the technology underlying
our molecular diagnostic tests and companion diagnostic services
tests and any future tests are terminated or cannot be maintained
on satisfactory terms; risks related to delays or other problems
with operating our laboratory testing facilities; risks related to
public concern over our genetic testing in general or our tests in
particular; risks related to regulatory requirements or enforcement
in the United States and foreign countries and changes in the
structure of the healthcare system or healthcare payment systems;
risks related to our ability to obtain new corporate collaborations
or licenses and acquire new technologies or businesses on
satisfactory terms, if at all; risks related to our ability to
successfully integrate and derive benefits from any technologies or
businesses that we license or acquire; risks related to increased
competition and the development of new competing tests and
services; the risk that we or our licensors may be unable to
protect or that third parties will infringe the proprietary
technologies underlying our tests; the risk of patent-infringement
claims or challenges to the validity of our patents; risks related
to changes in intellectual property laws covering our molecular
diagnostic tests and companion diagnostic services and patents or
enforcement in the United States and foreign countries, such as the
Supreme Court decision in the lawsuit brought against us by the
Association for Molecular Pathology et al; risks of new, changing
and competitive technologies and regulations in the United States
and internationally; and other factors discussed under the heading
"Risk Factors" contained in Item 1A of our most recent Annual
Report on Form 10-K filed with the Securities and Exchange
Commission, as well as any updates to those risk factors filed from
time to time in our Quarterly Reports on Form 10-Q or Current
Reports on Form 8-K. All information in this press release is as of
the date of the release, and Myriad undertakes no duty to update
this information unless required by law.
CONTACT: Media Contact:
Ron Rogers
(801) 584-3065
rrogers@myriad.com
Investor Contact:
Scott Gleason
(801) 584-1143
sgleason@myriad.com
Myriad Genetics (NASDAQ:MYGN)
Historical Stock Chart
From Aug 2024 to Sep 2024
Myriad Genetics (NASDAQ:MYGN)
Historical Stock Chart
From Sep 2023 to Sep 2024