Resverlogix Provides Groundbreaking Results in Patients with Severe Kidney Impairments
Geschrieben am 23-01-2017 |
Calgary, Alberta (ots/PRNewswire) -
Several Key Proteins That Drive Kidney (Renal) Disease and
Dialysis Risk are Downregulated After a Single Dose of Apabetalone
Resverlogix Corp. ("Resverlogix" or the "Company") (TSX: RVX)
today announced preliminary results from the New Zealand based Phase
1 trial with severe kidney (renal) impaired patients. The data showed
remarkable results in reducing inflamed protein biomarkers in
patients with severe kidney impairment versus healthy control
patients. It is believed that this is the first time in medical
history that a direct connection of this type can be made between
epigenetic regulation and its potential for positive disease impact.
Both the healthy group and the severely impaired kidney group
received equal amounts of apabetalone.
"It was shocking and highly encouraging to see the direct
comparison of the protein data ranked by magnitude of effect in the
two groups. For the first time, epigenetic and BET inhibition
clinical data has been shown to differentially affect genes and
proteins between advanced chronic kidney disease (CKD) patients and
normal subjects," stated Donald McCaffrey, President and CEO.
Dr. Kamyar Kalantar-Zadeh, Chairman of the Renal Clinical Advisory
Board and member of the BETonMACE Clinical Steering Committee stated,
"These early results help provide a first understanding of the
potential rapid effects of BET inhibition and apabetalone on key
proteins that drive risk and death in Stage 4 CKD and potentially
dialysis patients. Late Stage 4-5 CKD and dialysis patients represent
very important groups whom currently have limited therapeutic
strategies that can improve their outcomes and quality of life," Dr.
Kalantar-Zadeh added.
Ongoing expanded analysis of this exploratory data is also planned
which will look at Ingenuity Pathway Analysis (IPA). The quick onset
of action and improvement of reported CKD risk factors are
encouraging for the Company in their planned expansion beyond its
current cardiovascular and diabetes program. Detailed data will be
submitted for peer reviewed publications.
Clinical Trial Highlights
The study explored acute changes in biomarkers relevant to
subjects with Stage 4 CKD. Plasma components were analyzed using the
SOMAscan® assay, a sensitive, quantitative and reproducible proteomic
tool for measuring 1,310 proteins in the human proteome. Eight
patients with previously diagnosed Stage 4 CKD not on dialysis
(estimated glomerular filtration rate (eGFR) of less than 30
mL/min/1.73m2) were compared to eight matched healthy individuals
with normal renal function (eGFR range > 90 mL/min/1.73m2).
Protein data was collected following a single oral administration
of 100mg of apabetalone before and after multiple time points in both
cohorts. Protein levels of 289 proteins were significantly different
at baseline between the two groups (p<0.05). Initial findings from
this study revealed a highly differential protein signature at
baseline between CKD patients and controls. Following a single dose
administration of apabetalone in the Stage 4 CKD patients, the levels
of multiple plasma proteins were changed within 12 hours after
dosing, demonstrating a fast onset of drug action. Analysis of the
changes in protein levels at the 12-hour time point revealed that, in
the Stage 4 CKD patients, 33 percent of proteins had statistically
significant changes (p<0.05) compared to only 10 percent in the
controls. Of these significant proteins, several established renal
biomarkers such as interleukin 6 (IL6) and osteopontin, were
regulated positively with respect to disease severity and
progression.
About Advanced CKD & Dialysis
Advanced CKD encompasses Stages 4 & 5, and it can be alternatively
defined as an estimated glomerular filtration rate (eGFR) of <30
ml/min/1.73m2. As reported in the 2016 United States Renal Data
System (USRDS) Annual Report, approximately 1.4 million patients in
the US have advanced CKD, 474,000 of which are on dialysis treatment.
According to the USRDS, advanced CKD cost the US healthcare system
approximately US$17 billion in 2014, with an average annual cost
exceeding US$28,000 per patient. Additionally, dialysis treatment
costs the US Medicare system approximately US$28 billion with an
average annual cost exceeding US$80,000 per year. Currently there are
no known agents that improve Major Adverse Cardiac Events (MACE) in
CKD or dialysis patients.
About Resverlogix
Resverlogix is developing apabetalone (RVX-208), a first-in-class,
small molecule that is a selective BET (bromodomain and
extra-terminal) inhibitor. BET bromodomain inhibition is an
epigenetic mechanism that can regulate disease-causing genes.
Apabetalone is the first and only BET inhibitor selective for the
second bromodomain (BD2) within the BET protein called BRD4. This
selective inhibition of apabetalone on BD2 produces a specific set of
biological effects with potentially important benefits for patients
with diseases such as high-risk cardiovascular disease (CVD),
diabetes mellitus (DM), chronic kidney disease, Alzheimer's disease,
Orphan diseases, and peripheral artery disease, while maintaining a
well described safety profile. Apabetalone is the only selective BET
bromodomain inhibitor in human clinical trials, currently in a Phase
3 trial BETonMACE in high-risk CVD patients with type 2 DM and low
high-density lipoprotein (HDL).
Resverlogix common shares trade on the Toronto Stock Exchange
(TSX: RVX).
For further information please visit http://www.resverlogix.com.
Follow us on Twitter: @Resverlogix_RVX
(https://twitter.com/resverlogix_rvx)
(https://twitter.com/resverlogix_rvx), or 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 the Company's Phase 2 Renal
Impairment trial and Phase 3 clinical trial, and the potential role
of apabetalone in the treatment of CVD, DM, chronic kidney disease,
Alzheimer's disease, Orphan diseases, and peripheral artery 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 at http://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.
ots Originaltext: Resverlogix Corp.
Im Internet recherchierbar: http://www.presseportal.de
Contact:
please contact:
Investor Relations
Email: ir@resverlogix.com
Phone: +1-403-254-9252
Original-Content von: Resverlogix Corp., übermittelt durch news aktuell
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