Resverlogix Announces Combined RVX-208 Findings from SUSTAIN & ASSURE Phase 2b Trials
Geschrieben am 15-01-2014 |
Calgary, Alberta (ots/PRNewswire) -
"RVX-208 treated patients have significant lower MACE events in
high risk CVD patients"
TSX Exchange Symbol: RVX
Resverlogix Corp. today announced new information arising from
its ongoing analysis of data from both the SUSTAIN and ASSURE trials
in atherosclerotic patients with high risk for recurrent events. This
analysis, performed by an independent firm focuses on the potential
benefit of RVX-208, a first in class BET-inhibitor, to impact major
adverse cardiac events (MACE) over a short time period of 6 months.
When MACE data (n=499) from both SUSTAIN and ASSURE trials were
combined, it demonstrated that treatment with RVX-208 lead to a
significant reduction in MACE. RVX-208 treated patients (n=331), had
less cumulative events of 6.74% vs. 15.09% (p=0.02) in the placebo
treated group (n=168). Furthermore, in patients who had elevated CRP
> 2.0mg/dL (n=283) the benefit of RVX-208 treatment of patients
(n=179) appeared more striking with a cumulative event rate of 6.42%
vs. 20.53% (p=0.007) in the placebo group (n=104).
"Analysis of the ASSURE and SUSTAIN data arising from similar
atherosclerotic patients with high risk of recurrent events provides
important MACE information," stated Donald McCaffrey President and
Chief Executive Officer of Resverlogix. "A reduction in MACE will be
a critical factor for registration of RVX-208. This analysis provides
important information that RVX-208 when used in high risk
atherosclerosis patients improves the most central measurement of
all, the reduction of MACE in back to back trials" said Mr.
McCaffrey.
"We are very excited to have this independent MACE analyses
performed from the combined ASSURE and SUSTAIN trials to assess the
RVX-208 impact on death, non-fatal myocardial infarct,
hospitalizations from cardiac events and percutaneous invasive
procedures or revascularizations," stated Dr. Jan Johansson Senior
Vice President of Medical Affairs at Resverlogix. "This early data is
valuable to have as it illustrates in a cumulative fashion that
RVX-208 has the potential to really impact cardiac events in those
patients who are at very high risk," Johansson added.
About MACE
Major adverse cardiac events or MACE refers to adverse events
caused by disease processes generally affecting the coronary
arteries. These may include what are termed "hard" events such as
deaths that are attributed to coronary artery disease and nonfatal
myocardial infarctions but also occasionally "soft" events such as
angina or revascularizations for progressive coronary artery disease.
About RVX-208
RVX-208 is a first-in-class small molecule that inhibits BET
bromodomains. RVX-208 functions by removing atherosclerotic plaque
via reverse cholesterol transport (RCT), the natural process through
which atherosclerotic plaque is transported out of the arteries and
removed from the body by the liver. RVX-208 increases production of
Apolipoprotein A-I (ApoA-I), the key building block of functional
high-density lipoprotein (HDL) particles and the type required for
RCT. These newly produced, functional HDL particles are flat and
empty and can efficiently remove plaque and stabilize or reverse
atherosclerotic disease. Analysis of recent clinical trials data
showed that RVX-208 significantly reduces coronary atherosclerosis
and major adverse cardiac events in patients with CVD who have a low
level of HDL and elevated CRP, a population with unmet medical need.
ApoA-I may also exert beneficial effects in Alzheimer's disease and
Diabetes Mellitus.
About Resverlogix
Resverlogix Corp. is a clinical stage biotechnology company
developing compounds involving ApoA-I production. RVX-208 is a
first-in-class small molecule in development for the treatment of
diseases such as atherosclerosis, Diabetes Mellitus and Alzheimer's
disease. RVX-208 is the first BET bromodomain inhibitor in clinical
trials. Resverlogix's common shares trade on the Toronto Stock
Exchange . For further information please visit
http://www.resverlogix.com. We can be followed on our blog at
http://www.resverlogix.com/blog.
Resverlogix IR App
This app gives Resverlogix investors mobile access to the latest
stock data, news, and SEC Filings. It also provides proprietary
company content including presentations, conference calls, videos,
fact sheets, annual reports and other qualitative company
information. Investors are able to receive 'push' notifications when
new content is added to the IR App such as add events to calendars,
share content and as well as download files for offline viewing.
To download the Resverlogix IR App, please visit your app store.
Apple Products (iPhone, iPad, and iPod's) - https://itunes.apple.c
om/WebObjects/MZStore.woa/wa/viewSoftware?id=730718904&mt=8 Android
Products (Google Play, Tablets and Smartphones) - https://play.google
.com/store/apps/details?id=com.theirapp.resverlogix
This news release may contain certain forward-looking information
as defined under applicable Canadian securities legislation, that are
not based on historical fact, including without limitation statements
containing the words "believes", "anticipates", "plans", "intends",
"will", "should", "expects", "continue", "estimate", "forecasts" and
other similar expressions. In particular, this news release includes
forward looking information relating to research and development
activities and the potential role of RVX-208 in the treatment of
atherosclerosis. Our actual results, events or developments could be
materially different from those expressed or implied by these
forward-looking statements. We can give no assurance that any of the
events or expectations will occur or be realized. By their nature,
forward-looking statements are subject to numerous assumptions and
risk factors including but not limited to those associated with the
success of research and development programs, clinical trial programs
including possible delays in patient recruitment, the regulatory
approval process, competition, securing and maintaining corporate
alliances, market acceptance of the Company's products, the
availability of government and insurance reimbursements for the
Company's products, the strength of intellectual property, financing
capability, the potential dilutive effects of any financing, reliance
on subcontractors and key personnel and additional assumptions and
risk factors discussed in our Annual Information Form and most recent
MD&A which are incorporated herein by reference and are available
through SEDAR athttp://www.sedar.com. The forward-looking statements
contained in this news release are expressly qualified by this
cautionary statement and are made as of the date hereof. The Company
disclaims any intention and has no obligation or responsibility,
except as required by law, to update or revise any forward-looking
statements, whether as a result of new information, future events or
otherwise.
Company Contacts:
Donald J. McCaffrey
President and CEO
Resverlogix Corp.
Phone: +1-403-254-9252
Email: don@resverlogix.com
Kenneth Lebioda
SVP Business & Corporate Development
Resverlogix Corp.
Phone: +1-403-254-9252
Email: ken@resverlogix.com
ots Originaltext: Resverlogix Corp.
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