Tekmira's Partner Initiates Phase III Trial With LNP-Enabled Patisiran
Phase II Data Presented at Scientific Symposium Further Validates Tekmira's
VANCOUVER, British Columbia, Nov. 10, 2013 (GLOBE NEWSWIRE) -- Tekmira
Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM), a leading developer of
RNA interference (RNAi) therapeutics, today reported that Alnylam
Pharmaceuticals, Inc. (Nasdaq:ALNY) presented positive results from its Phase
II clinical trial with patisiran (ALN-TTR02), an RNAi therapeutic targeting
transthyretin (TTR) for the treatment of TTR-mediated amyloidosis (ATTR),
which is enabled by Tekmira's lipid nanoparticle (LNP) technology. The program
represents the most clinically advanced application of Tekmira's proprietary
LNP delivery technology.
"Today's most significant RNAi advances within the clinic are driven by
Tekmira's LNP technology. We are pleased to report patisiran (ALN-TTR02),
which is enabled by Tekmira's leading LNP technology, has entered a Phase III
clinical trial. Our LNP delivery technology continues to be validated by
positive clinical data, with these Phase II results demonstrating a product
that is effective, safe and well tolerated. Our LNP is enabling multiple RNAi
products in clinical development in a variety of therapeutic areas, including
our own robust product pipeline, as well as partner products," said Dr. Mark
J. Murray, Tekmira's President and CEO.
Alnylam presented data at the IXth International Symposium on Familial
Amyloidotic Polyneuropathy (ISFAP) being held in Rio de Janeiro, Brazil,
November 10-13. Alnylam reported results showing that multiple doses of
patisiran led to robust and statistically significant knockdown of serum TTR
protein levels of up to 96%, with mean levels of TTR knockdown exceeding 85%.
Knockdown of TTR, the disease-causing protein in ATTR, was found to be rapid,
dose dependent, and durable, and similar activity was observed toward both
wild-type and mutant protein. In addition, patisiran was found to be generally
safe and well tolerated in this study.
Alnylam also announced today the initiation of the APOLLO Phase III trial of
patisiran, with the study now open for enrollment, to evaluate efficacy and
safety of patisiran in ATTR patients with Familial Amyloidotic Polyneuropathy
(FAP). Tekmira is entitled to receive a US$5M milestone payment upon dosing of
the first patient within this trial.
For more detailed information about the initiation of the APOLLO Phase III
trial and the newly presented Phase II data for patisiran (ALN-TTR02), please
refer to the Alnylam news release dated November 10, 2013 and the presentation
of these data, which can be found on Alnylam's website at www.alnylam.com.
About RNAi and Tekmira's LNP
RNAi therapeutics have the potential to treat a broad 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 therapeutics, such as "siRNAs," require delivery
technology to be effective systemically. Tekmira believes its LNP technology
represents the most widely adopted delivery technology for the systemic
delivery of RNAi therapeutics. Tekmira's LNP platform is being utilized in
multiple clinical trials by both Tekmira and its partners. Tekmira's LNP
technology (formerly referred to as stable nucleic acid-lipid particles or
SNALP) encapsulates siRNAs with high efficiency in uniform lipid nanoparticles
that are effective in delivering RNAi therapeutics to disease sites in
numerous preclinical models. 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 FDA divisions for use in
clinical trials. LNP formulations comprise several lipid components that can
be adjusted to suit the specific application.
Tekmira Pharmaceuticals Corporation is a biopharmaceutical company focused on
advancing novel RNAi therapeutics and providing its leading lipid nanoparticle
delivery technology to pharmaceutical partners. Tekmira has been working in
the field of nucleic acid delivery for over a decade and has broad
intellectual property covering LNPs. Further information about Tekmira can be
found at www.tekmirapharm.com. Tekmira is based in Vancouver, B.C.
Forward-Looking Statements and Information
Forward-looking statements in this news release include statements about
Tekmira's strategy, future operations, clinical trials, prospects and the
plans of management; RNAi (ribonucleic acid interference) product development
programs; the quantum and timing of future partner milestone payments,
including the US$5M payment upon dosing of the first patient within the Phase
III APOLLO trial with patisiran.
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; Tekmira's research and
development capabilities and resources; and the time required for development
partners and licensees to complete research and product development
activities. 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: Tekmira's development partners and licensees conducting
clinical trial, development programs and joint venture strategic alliances
will not result in expected results on a timely basis, or at all; and,
anticipated milestone and royalty payments under contracts with Tekmira's
collaborative partners – including a US$5M milestone payment dosing of the
first patient within the Phase III APOLLO trial with patisiran – may not be
received by Tekmira on a timely basis, or at all, or in the quantum expected
A more complete discussion of the risks and uncertainties facing Tekmira
appears in Tekmira's annual report on Form 20-F for the year ended December
31, 2012 (Annual Report), which is available at www.sedar.com or at
www.sec.gov/edgar.shtml. 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.
Director, Investor Relations
Longview Communications Inc.
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