TKM-HBV, a Leading RNAi Approach to Reduce Hepatitis B Surface Antigen, Has the Potential to Play a Central Role in the Cure of Chronic Hepatitis B Virus Infection
VANCOUVER, British Columbia, Jan. 21, 2015 (GLOBE NEWSWIRE) --
Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM), a leading
developer of RNA interference (RNAi) therapeutics, announced today that
it has dosed the first subject in a Phase I clinical trial of TKM-HBV, a
therapeutic agent designed to reduce hepatitis B surface antigen in
patients chronically infected with hepatitis B virus (HBV).
"We are pleased to have reached this important milestone, initiation of
phase I studies with TKM-HBV. Since TKM-HBV represents our most
important development program, we are testing two LNP formulations,
generations three and four, of the product in this study. We expect the
results to determine which product formulation we will advance into
chronically infected patients later this year," said Dr. Mark J. Murray,
Tekmira's President and CEO.
The TKM-HBV Phase I clinical trial is a randomized, single-blind,
placebo-controlled study, involving single ascending doses of TKM-HBV.
The study will assess the safety, tolerability and pharmacokinetics of
intravenous administration of two formulations of TKM-HBV in healthy
adult subjects. For each formulation, there are five planned cohorts for
a total of 20 subjects (40 in total for both formulations). Four
subjects will be enrolled per cohort with three subjects receiving
TKM-HBV, and one receiving placebo.
About TKM-HBV
The goal of TKM-HBV is to facilitate hepatitis B surface antigen
(HBsAg) loss in patients with chronic hepatitis B. The continued
presence of HBsAg in chronic HBV is believed to be responsible for
disease pathogenesis and impairing the body's ability to clear the
virus. Blocking HBsAg may lead to a functional cure by promoting
immune-mediated clearance and control of HBV, potentially through HBsAg
seroconversion. TKM-HBV is a novel lipid nanoparticle (LNP) formulated
RNAi therapy that uniquely targets three highly conserved regions of the
HBV viral genome. Targeting multiple sites on the HBV genome allows for
potent reduction of multiple viral antigens, knockdown across a broad
range of HBV genotypes, and a decrease in the probability of developing
antiviral resistance. Preclinical studies with TKM-HBV have shown
reductions of HBsAg and other important viral markers across the most
prevalent HBV genotypes, demonstrating that TKM-HBV has the potential to
treat patients with chronic HBV.
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
focused on advancing novel RNAi therapeutics and providing its leading
lipid nanoparticle (LNP) delivery technology to pharmaceutical and
biotechnology partners. Tekmira has been working in the field of nucleic
acid delivery for over a decade, and has broad intellectual property
covering its delivery technology. Further information about Tekmira can
be found at www.tekmira.com. Tekmira is based in Vancouver, Canada and Seattle, USA.
Forward-Looking Statements and Information
This news release contains "forward-looking statements" or
"forward-looking information" within the meaning of applicable
securities laws (collectively, "forward-looking statements").
Forward-looking statements in this news release include statements about
Tekmira's strategy, future operations, clinical trials, prospects and
the plans of management; RNAi as a leading approach in the treatment of
HBV; TKM-HBV representing a central role in the treatment and potential
cure of HBV; initiation of the Phase I clinical study in human healthy
volunteers with two formulations of TKM-HBV comprising a third
generation LNP and a new fourth generation LNP, which contains novel
lipid chemistry and has shown improved potency in certain pre-clinical
studies; and to progress to chronically infected patients later in the
year; the effects and potency of Tekmira's product TKM-HBV to reduce
hepatitis B
surface antigen in patients with chronic hepatitis B infection; and
estimations of unmet demands for TKM-HBV.
With respect to the forward-looking statements contained in this news
release, Tekmira has made numerous assumptions regarding, among other
things: LNP's status as a leading RNAi delivery technology; the
effectiveness of RNAi therapeutics in the treatment of hepatitis B
virus; and the results of pre-clinical studies. 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: RNAi based
therapeutics may not prove to be effective in the treatment of hepatitis
B virus as currently anticipated, compared to other therapeutics, or at
all; TKM-HBV may not prove to have any significance in the treatment of
HBV; a cure for HBV may never be discovered; Tekmira may not initiate
all the clinical trials for TKM-HBV as currently anticipated, or at all;
the FDA or other regulatory agencies may refuse to approve Tekmira's
products, or place restrictions on Tekmira's ability to commercialize
its products; 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; future operating
results are uncertain and likely to fluctuate; economic and capital
market conditions; and the possibility that Tekmira may not have
sufficiently budgeted for expenditures necessary to carry out planned
activities.
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 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.
Additional Information
and Where to Find It
Tekmira plans to file with the Securities and Exchange Commission (the
"SEC") and mail to its stockholders a proxy statement in connection with
the proposed Merger. The proxy statement will contain important
information about the proposed Merger and related matters. INVESTORS AND
STOCKHOLDERS ARE URGED TO READ THE PROXY STATEMENT CAREFULLY IN ITS
ENTIRETY WHEN IT BECOMES AVAILABLE. Investors and stockholders will be
able to obtain free copies of the proxy statement and other documents
filed with the SEC by Tekmira through the SEC's website at www.sec.gov
and from Tekmira by contacting Investor Relations by telephone at (604)
419-3200 or upon written request addressed to our corporate secretary
at Tekmira Pharmaceuticals Corporation, 100 - 8900 Glenlyon
Parkway, Burnaby, BC, Canada, V5J 5J8 or by going to Tekmira's Investor
section on its corporate web site at www.tekmira.com.
Tekmira and its executive officers and directors may be deemed to be
participants in the solicitation of proxies from the stockholders of
Tekmira in connection with the proposed Merger. Information regarding
the interests of these executive officers and directors in the
transaction described herein will be included in the proxy statement
described above. Additional information regarding these executive
officers and directors is also included in Tekmira's Annual Report on
Form 10-K, which was filed with the SEC on March 28, 2014, and is
supplemented by other public filings made, and to be made, with the SEC
by Tekmira. The Annual Report on Form 10-K and other public filings are
available free of charge through the SEC's website at www.sec.gov
and from Tekmira
by contacting Investor Relations by telephone at (604) 419-3200 or upon
written request addressed to our corporate secretary at Tekmira
Pharmaceuticals Corporation, Tekmira Pharmaceuticals Corporation, 100 -
8900 Glenlyon Parkway, Burnaby, BC, Canada, V5J 5J8 or by going to
Tekmira's Investor section on its corporate web site at www.tekmira.com.
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
Labels: clinical trials, RNAi, Tekmira, TKM-HBV