Further Analysis of the ASSURE Data Finds a Responder Group for RVX-208 with Statistically Significant Regression of Coronary Atherosclerosis
Geschrieben am 03-09-2013 |
Calgary, Alberta (ots/PRNewswire) -
"In patients with low HDL receiving RVX-208 and Rosuvastatin
(Crestor(R)), plaque regression was twice as pronounced as compared
to the pre-specified primary endpoint."
TSX Exchange Symbol: RVX
Resverlogix Corp. today announced the Full Analysis Set (FAS)
data from 281 treated patients in its Phase 2b ASSURE clinical trial
evaluating RVX-208 using intravascular ultrasound (IVUS) in high-risk
cardiovascular patients. Current findings show that the below median
HDL (<39 mg/dL) baseline population consisted of 92 patients who were
taking either Rosuvastatin (Crestor(R)) or Atorvastatin (Lipitor(R))
together with RVX-208. Those patients taking Rosuvastatin and RVX-208
had a highly statistically significant Percent Atheroma Volume (PAV)
plaque regression of -1.43% with probability value of p<0.002. This
PAV regression exceeded the trial's pre-specified PAV endpoint
(-0.6%) by more than two-fold. But those patients taking Atorvastatin
(Lipitor(R)) together with RVX-208 had a PAV plaque progression of
+0.19% with a non-significant probability value. The synergistic
effect of the Rosuvastatin and RVX-208 combination is the basis for
two recent provisional patent applications by Resverlogix.
Ongoing analysis is providing important insights into why the
ASSURE topline results, reported previously on June 27, 2013, did not
meet its primary endpoint of PAV change of -0.6%. Third party
analysis of the ASSURE data showed that Rosuvastatin enhanced the
actions of RVX-208 leading to synergistic treatment effects on PAV.
The responder population (i.e. HDL <39 mg/dL taking Rosuvastatin
and RVX-208) exceeded the primary endpoint and also surpassed
secondary endpoints reflecting regression in coronary
atherosclerosis. These measures included total atheroma volume (TAV)
and changes in the 10 mm most diseased segment of the coronary
arteries, we noted marked regression versus baseline of -12.3 mm[3](
p< 0.0001) and -4.3 mm[3 ](p<0.0001), respectively. Other secondary
endpoints assessed in this population were biomarkers of reverse
cholesterol transport (RCT), including: HDLc, ApoA-I and large HDL
particles which increased by 18.2% (p<0.0001), 16.4% (p<0.0001) and
74.7% (p<0.0001), respectively, vs. baseline.
"Clearly we have good reason to be very excited given the positive
findings of a synergistic effect between Rosuvastatin and RVX-208 on
coronary atherosclerosis. We were excited to observe that the RVX-208
responsive group did not differ from the originally intended
population, namely those with low HDL receiving standard of care
therapy. Our findings identify a statin that is superior when
combined with RVX-208. These findings support two filed patent
applications, thus potentially enabling patent protection until the
year 2033 or beyond," said Donald McCaffrey, president and chief
executive officer of Resverlogix.
Dr. Jan Johansson, senior vice president of medical affairs of
Resverlogix added, "Plaque composition data recently reported at the
European Society of Cardiology, showed significant plaque
stabilization by RVX-208. In support of this finding, we noted an
important trend in the ASSURE trial in that RVX-208 appeared to
reduce major adverse cardiac events (MACE) including death from
myocardial infarction (MI), MI without death, and revascularization.
When events in ASSURE and the previously completed 24 week SUSTAIN
trial were combined the MACE numbers were 46% less in the RVX-208
treated vs. the placebo population (p=0.09). But neither trial was
designed or powered for MACE. Furthermore, the safety component of
both trials again illustrated that the rare RVX-208 induced rise in
the ALT was benign and manageable, i.e.) short in duration and
appearing prior to week 12 of dosing. These findings are valuable for
the development of RVX-208, the first BET-protein inhibitor to be
tested in human clinical trials for cardiovascular disease."
Resverlogix will host a conference call and webcast with Q&A
today, September 3rd at 11 am MDT.
Details for the conference call and webcast are as follows:
Link to webcast:
http://services.choruscall.ca/links/resverlogix130905.html
Dial in numbers:
Canada & USA Toll Free Dial In: 1-800-319-4610 Outside of Canada &
USA call: +1-604-638-5340
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. ApoA-I may also exert beneficial effects in
Diabetes Mellitus and Alzheimer's disease.
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.
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
diseases such as atherosclerosis, Diabetes Mellitus and Alzheimer's
disease. 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 those 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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