Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR) an
industry-leading therapeutic solutions company focused on
developing a cure for chronic hepatitis B virus infection (HBV),
announced today that new preclinical data on TKM-HTG, an RNAi
therapeutic, were presented at the Keystone Symposia Conference:
Liver Metabolism and Nonalchoholic Fatty Liver Diseases, in
Whistler, Canada, March 22-27, 2015. Dr. Narayanan Hariharan,
Senior Director of Research for Tekmira, delivered a podium
presentation at the conference titled, "Novel RNAi-Lipid
Nanoparticle Therapeutics for Hypertriglyceridemia," and a poster
presentation titled, "TKM-ApoC3, an RNAi-Lipid Nanoparticle
Therapeutic, Ameliorates Hypertriglyceridemia and Improves
Metabolic Profile in Human-ApoC3 Transgenic Mice."
TKM-HTG is a product candidate in Tekmira's non-HBV product
pipeline for the treatment of hypertriglyceridemia (HTG). TKM-HTG
is being developed as a dual component RNAi therapeutic that
simultaneously targets two important genes expressed in the liver,
which are known to play a significant and complementary role in
triglyceride metabolism. The most important finding obtained in the
pre-clinical studies are the super-additive effects on plasma
triglycerides by silencing the Apolipoprotein C3 (ApoC3) and
Angiopoietin like protein 3 (ANGPTL3) genes, which are expressed in
the liver, in a well validated model of HTG. High triglyceride
levels are medically linked to an increased risk of cardiovascular
disease, fatty liver disease, insulin resistance and
pancreatitis.
"Today, Dr. Narayanan Hariharan presented exciting pre-clinical
data demonstrating a unique mechanism of action of our TKM-HTG
agent which reflects the value, we believe, resides in our non-HBV
assets. Our aim is to achieve rapid and sustained reductions of
triglycerides and address the limitations of existing HTG
treatments with TKM-HTG," said Dr. Mark J. Murray, Tekmira's
President and CEO. "We are encouraged by the results presented and
we are advancing TKM-HTG into investigational new drug
application-enabling studies."
Key summary points from Dr. Hariharan's presentation
include:
- Preclinical studies employed two well validated models of HTG
including human ApoC3 transgenic (Tg) mouse model and high-fat
containing diet fed mouse model. In the human ApoC3-Tg mouse model,
silencing of ApoC3 gene was accomplished, which resulted in rapid,
potent and sustained plasma triglyceride (TG) lowering, with the
lowest effective dose at 0.03 mg/kg. Duration of gene silencing and
TG lowering effects from a single administration of the ApoC3 RNAi
trigger lasted for more than 2 weeks.
- In addition, beneficial cholesterol profile changes and
significant glucose lowering effects were also observed.
- In the high-fat containing diet fed mouse model, silencing of
both the ApoC3 and ANGPTL3, genes, resulted in super-additive
plasma triglycerides lowering effects. Doses of 0.125 mg/kg + 0.125
mg/kg in combination were superior to either 0.25 mg/kg or 0.5
mg/kg for the individual RNAi-triggers. This demonstrates the
advantage of using a dual-component RNAi-therapeutic for the
potential treatment of HTG.
Presentation Information
A copy of Tekmira's slides from the Keystone Symposia
Conference: Liver Metabolism and Nonalchoholic Fatty Liver Diseases
will be available on the Tekmira website on the "Events" section
at: http://investor.tekmirapharm.com/events.cfm.
About Hypertriglyceridemia
Hypertriglyceridemia (HTG), a type of dyslipidemia where there
are high blood levels of triglycerides (TGs), is an independent
risk factor for cardiovascular diseases. Different patient groups
are affected by HTG. This includes Familial Chylomicronemia
Syndrome (FCS), which is a very rare hereditary condition affecting
an estimated one in one million people (http://fcs.raredr.com).
Patients with severe HTG, (classified as triglyceride levels
greater than 1000 mg/dL) are at risk of acute pancreatitis.
Approximately one million adults in the US and 18 million people
worldwide suffer from severe HTG. (NHANES1 2003-2004 data).
Furthermore, 35% of patients with Type 2 Diabetes suffer from mixed
hyperlipidemia; which is a combination of elevated cholesterol and
high triglycerides. These patients are also at considerable risk
from cardiovascular disease, because the HTG in these patients is
often refractory to statin treatment (Diabetes, Metabolic Syndrome
and Obesity: Targets and Therapy 2013, 6, 11-15).
About RNAi and Tekmira's LNP
RNAi therapeutics have the potential to treat a number of human
diseases by "silencing" disease causing genes. The discoverers of
RNAi, a gene silencing mechanism used by all cells, were awarded
the 2006 Nobel Prize for Physiology or Medicine. RNAi trigger
molecules often require delivery technology to be effective as
therapeutics. Tekmira believes its LNP technology represents the
most advanced and widely adopted delivery technology for the
systemic delivery of RNAi triggers. Tekmira's LNP platform is being
utilized in multiple clinical trials in various disease areas by
Tekmira and its partners. Tekmira's LNP technology (formerly
referred to as stable nucleic acid-lipid particles or SNALP)
encapsulates RNAi triggers with high efficiency in uniform lipid
nanoparticles that are effective in delivering these therapeutic
compounds to disease sites. Tekmira's LNP formulations are
manufactured by a proprietary method which is robust, scalable and
highly reproducible, and LNP-based products have been reviewed by
multiple regulatory agencies for use in clinical trials. LNP
formulations comprise several lipid components that can be adjusted
to suit the specific application.
About Tekmira
Tekmira Pharmaceuticals Corporation is a biopharmaceutical
company dedicated to discovering, developing and commercializing a
cure for patients suffering from chronic hepatitis B infection
(HBV). Our strategy is to target the three pillars necessary to
develop a curative regimen for HBV, including suppressing HBV
replication within liver cells, stimulating and reactivating the
body's immune system so that it can mount an effective defense
against the virus and, most importantly, eliminating the reservoir
of viral genomic material known as covalently closed circular DNA,
or cccDNA, that is the source of HBV persistence. Our portfolio of
assets includes eight drug candidates for use in combination to
develop a cure for HBV, and includes our product TKM-HBV currently
in Phase 1 clinical studies.
We also have a pipeline of non-HBV assets in oncology,
anti-viral and metabolic therapeutics that leverage our expertise
in RNA interference (RNAi) therapeutics and leading Lipid
Nanoparticle (LNP) technology. RNAi and LNP technology have the
potential to generate new therapeutics that take advantage of the
body's own natural processes to silence disease causing genes, or
more specifically, to eliminate specific gene-products, from the
cell. We intend to maximize the value of our non-HBV assets in the
clinic, namely: TKM-PLK1 for advanced gastrointestinal
neuroendocrine tumors, adrenocortical carcinoma and hepatocellular
carcinoma; and TKM-Ebola, and TKM-Ebola-Guinea for ebola virus
disease; as well as our preclinical programs in metabolic disorders
and filoviruses.
Tekmira is headquartered in Vancouver, BC, Canada with offices
in Doylestown, PA, USA. For more information, visit
www.tekmira.com.
Forward-Looking Statements and Information
This press release contains forward-looking statements within
the meaning of the Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934, and forward
looking information within the meaning of Canadian securities laws
(collectively, "forward-looking statements"). Forward-looking
statements in this press release include statements about aiming to
achieve rapid and sustained reductions of triglycerides and address
the limitations of existing HTG treatments with TKM-HTG; advancing
TKM-HTG into investigational new drug application-enabling studies;
the potential of RNAi therapeutics; Tekmira's LNP technology being
the most advanced and widely adopted delivery technology for the
systemic delivery of RNAi triggers; Tekmira's strategy for
discovering, developing and commercializing a cure for HBV; and
Tekmira's intent to maximize the value of their non-HBV assets.
With respect to the forward-looking statements contained in this
press release, Tekmira has made numerous assumptions regarding,
among other things: LNP's status as the most advanced RNAi delivery
technology. While Tekmira considers these assumptions to be
reasonable, these assumptions are inherently subject to significant
business, economic, competitive, market and social uncertainties
and contingencies.
Additionally, there are known and unknown risk factors which
could cause Tekmira's actual results, performance or achievements
to be materially different from any future results, performance or
achievements expressed or implied by the forward-looking statements
contained herein. Known risk factors include, among others: TKM-HTG
may not prove to be effective in the treatment of HTG; the use of
TKM-HTG may not be able to address the limitations of existing HTG
treatments; Tekmira's products may not prove to be effective or as
potent as currently believed; the FDA may refuse to approve
Tekmira's products, or place restrictions on Tekmira's ability to
commercialize its products; Tekmira may not obtain and protect
intellectual property rights, and operate without infringing on the
intellectual property rights of others; Tekmira may face
competition from other pharmaceutical or biotechnology companies
and the possibility that other organizations have made advancements
in RNAi delivery technology that Tekmira is not aware of;
anticipated pre-clinical and clinical trials may be more costly or
take longer to complete than anticipated, and may never be
initiated or completed, or may not generate results that warrant
future development of the tested drug candidate; and economic and
capital market conditions.
A more complete discussion of the risks and uncertainties facing
Tekmira appears in Tekmira's Annual Report on Form 10-K and
Tekmira's continuous disclosure filings, which are available at
www.sedar.com and at www.sec.gov. All forward-looking statements
herein are qualified in their entirety by this cautionary
statement, and Tekmira disclaims any obligation to revise or update
any such forward-looking statements or to publicly announce the
result of any revisions to any of the forward-looking statements
contained herein to reflect future results, events or developments,
except as required by law.
1 NHANES is the National Health and Nutrition Examination
Survey, part of the U.S. CDC.
CONTACT: Investors
Julie P. Rezler
Director, Investor Relations
Phone: 604-419-3200
Email: jrezler@tekmira.com
Media
Please direct all media inquiries to media@tekmira.com
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