Resverlogix Presents New Complement Data and Establishes Renal Clinical Advisory Board at the 53rd Annual European Renal Association - European Dialysis & Transplant Association Congress (ERA-EDTA
Geschrieben am 25-05-2016 |
Calgary, Alberta (ots/PRNewswire) -
"Apabetalone, a selective bromodomain extra-terminal (BET) protein
inhibitor that significantly decreases abundance and activity of
complement proteins"
Resverlogix Corp. ("Resverlogix" or the "Company") (TSX:RVX)
announces that new data was presented at the ERA-EDTA Congress in
Vienna, Austria in a poster titled: "Apabetalone (RVX-208), a
Selective Bromodomain and Extra-Terminal (BET) Protein Inhibitor,
Decreases Abundance and Activity of Complement Proteins in Vitro, in
Mice and in Clinical Studies". The Company is also pleased to
announce the formation of an International Renal Clinical Advisory
Board (RCAB) for the future development of apabetalone into expanded
renal indications.
New Complement Data Announced at ERA-EDTA Congress - Vienna,
Austria
The immune system is the body's way of protecting itself from
attacking foreign invaders, such as bacteria, viruses, illness, and
disease. The complement cascade is part of this protective response,
however pathological activation of the cascade underlies multiple
human diseases including several inflammatory, autoimmune,
neurodegenerative and infectious diseases.
New data demonstrated that when exposed to apabetalone, primary
human liver cells significantly downregulate the expression of
complement components. This was observed at both the gene expression
and protein level, and occurred at steady state (when unstimulated)
and when the cells were stimulated with factors known to cause
inflammation and immune response activation. This is particularly
important in conditions where these factors are overactive or present
in excessive quantities. Moreover, in an apabetalone treated mouse
model, where mouse liver cells are replaced with human liver cells,
reductions in expression of components C4, C9 and MBL2 mRNA of the
complement cascade, decreased by 36 percent, 46 percent and 61
percent respectively. To establish if the observed decrease in
protein abundance affected activity, hemolytic assays were performed
on 11 plasma samples from patients with cardiovascular disease (CVD)
at baseline, and after 26 weeks of apabetalone treatment. Results
showed a significant decrease in activity of approximately 26 percent
(p<0.01) in both assays. No increase in infections was reported in
phase 2 trials.
This effect of apabetalone treatment on complement component
expression and cascade activity may have an impact on the pathologic
activation of this cascade in Chronic Kidney Disease (CKD). The
potential of apabetalone for the treatment of high-risk diabetes and
CKD patients is currently being explored in the Company's Phase 3
BETonMACE clinical study.
Dr. Kamyar Kalantar-Zadeh, Chairman of the RCAB, stated, "BET
inhibition with apabetalone represents a novel and compelling
approach for diabetes and CKD treatment. This data in combination
with previously published findings on novel biomarkers and pathways
affected by select BET inhibition with known roles in CVD and CKD
such as, coagulation, vascular calcification and inflammation,
provide a potentially unique and multifactorial approach to disease
reduction. The RCAB intend to examine expanded opportunities in renal
disease where patients have a significant risk for major adverse
cardiac events (MACE) such as death, stroke, heart failure and
myocardial infarction".
"This new data is an important step for the Company as we continue
to develop our proprietary BET data for high risk CVD patients and
apply these learnings into additional indications in kidney and renal
orphan diseases," said Mr. Donald McCaffrey, President and CEO. "The
data showing that select BET inhibition is modulating key pathways
and proteins known to play a role in renal disease, is directly
responsible for attracting world-class leaders in the field of renal
disease research to help expand and direct our efforts."
Members of the Resverlogix International Renal Clinical Advisory
Board:
Dr. Kamyar Kalantar-Zadeh (Chair): Dr. Kalantar-Zadeh is Professor
and Chief, Division of Nephrology and Hypertension at University of
California, Irvine. Dr. Kalantar-Zadeh is the founder and director of
the Harold Simmons Center for Kidney Disease Research and
Epidemiology. Among his numerous appointments in the renal field Dr.
Kalantar-Zadeh is Associate Editor of several peer-reviewed journals
including Nephrology Dialysis Transplantation (NDT), American Journal
of Kidney Diseases (AJKD), Cardiorenal Medicine (CRM), Seminars in
Dialysis, sarcopenia and Muscle (JCSM), and a member of the editorial
board of Journal of Kidney International (KI), Journal of American
Society Nephrology (JASN), Nature Reviews Nephrology, American
Journal of Nephrology (AJN). Dr. Kalantar-Zadeh has authored 3
textbooks and over 500 peer reviewed publications.
Dr. Carmine Zoccali: Dr. Zoccali is a specialist in Renal Diseases
(Pisa University) and Hypertension. Dr. Zoccali's appointments
include: Director, Division of Nephrology, Hypertension and Renal
Transplantation, Ospedali Riuniti, Reggio Cal, Italy; Chief, CNR-IBIM
Clinical Epidemiology and Pathophysiology of Renal Diseases and
Hypertension; Professor, Postgraduate Schools of Nephrology, Palermo,
Catania and Messina Universities. Dr. Zoccali's current editorial
positions include: Editor in Chief, Nephrology Dialysis and
Transplantation, Academic Editor, (Nephrology) PlosOne, and Editorial
Board member, Journal of the American Society of Nephrology (JASN).
Editorial Board member, Clinical Journal of the American Society of
Nephrology (cJASN) and Editorial Board member, Kidney International
(KI). Dr. Zoccali has over 402 papers in international peer-reviewed,
Pubmed indexed journals.
Dr. Marcello Tonelli: Dr. Tonelli is Associate Vice-President
(Research) at the University of Calgary. Dr. Tonelli was the
recipient of the 2013 United States National Kidney Foundation Medal
for Distinguished Service and the Kidney Foundation of Canada's 2013
Medal for Research Excellence for changing nephrology practice in
Canada and beyond. Along with the two other team co-leads, he
received a Top Canadian Achievements in Health Research Award from
the CIHR-CMAJ in 2013 for his work with the Interdisciplinary Chronic
Disease Collaboration. He was elected a fellow of the Canadian
Academy of Health Sciences in 2012 and a member of the American
Society for Clinical Investigation in 2014. He was named a "Highly
Cited" researcher in 2015 by Thomson-Reuters, corresponding to a rank
in the top 1% by citations of all researchers worldwide for field and
publication year.
Dr. Vincent Brandenburg: Dr. Brandenburg is Nephrologist,
Associate Professor and Senior Consultant at the Department of
Cardiology, Intensive Care Medicine and Vascular Medicine, University
Hospital of the RWTH Aachen, Germany. Dr. Brandenburg has been leader
of the German Calciphylaxis registry (http://www.calciphylaxie.de)
since 2007. He is a board member of the ERA-EDTA scientific working
group Chronic Kidney Disease - Mineral and Bone Disorder (CKD-MBD).
Dr. Brandenburg has authored or co-authored over 140 articles in
peer-reviewed journals. These articles have had the primary focus
upon chronic kidney disease - mineral and bone disorder, cardiorenal
syndrome, and calciphylaxis. He is a member of the German and
European Societies of Nephrology and the Societies of Cardiology.
Dr. Srinivasan Beddhu: Dr. Beddhu, MD is a tenured Professor of
Medicine at the University of Utah School of Medicine. He is Board
Certified in Internal Medicine and Nephrology. Dr. Beddhu received
his medical degree from Stanley Medical College, Chennai, India. His
clinical and research interests include hypertension, chronic kidney
disease progression and complications and end-stage renal disease.
Dr. Beddhu's research is funded primarily by NIH grants. He has
served in several national committees including NIH panels, American
Society of Nephrology Research Committee and NKF clinical practice
guidelines committee. Dr. Beddhu has published about 100 articles
including peer-reviewed publications, editorials and book chapters.
Dr. Mathias Haarhaus: Dr. Haarhaus is a Consultant Nephrologist at
the Department of Nephrology, Karolinska University Hospital,
Stockholm, Sweden, where he is head of the Bone and Mineral Program.
His research at the Division of Renal Medicine, Karolinska
Institutet, mainly focuses on the link between skeletal disorders and
cardiovascular complications in chronic kidney disease, with a
special focus on alkaline phosphatase. He is an active member of the
Chronic Kidney Disease - Mineral and Bone Disorder (CKD-MBD) working
group of the European Renal Association - European Dialysis and
Transplantation Association (ERA-EDTA) and a member of the Guidelines
Committee of the Swedish Society of Nephrology.
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 (CKD), 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 via: 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 potential role of
apabetalone in the treatment of CVD, DM, CKD, complement component
expression, 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: 403-254-9252
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