Tekmira to Present TKM-PLK1 Phase 1 Clinical Trial Results at AACR
VANCOUVER, British Columbia, Feb. 4, 2013 (GLOBE NEWSWIRE) -- Tekmira
Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM), a leading developer of
RNA interference (RNAi) therapeutics, announced today that it has been
selected as an oral presenter at the annual meeting of the American
Association for Cancer Research (AACR) taking place in Washington, DC from
April 6-10, 2013.
"We are pleased that we have this opportunity to present Phase 1 clinical
trial data from our lead oncology program, TKM-PLK1, at the AACR conference.
We have completed the dose escalation portion of the trial and are continuing
to enroll patients in an expansion cohort at the maximum tolerated dose. Our
TKM-PLK1 program will enter a Phase 2 trial later in 2013," said Dr. Mark J.
Murray, Tekmira's President and CEO.
The study investigators will deliver a presentation entitled "A phase 1 dose
escalation study of TKM-080301, a RNAi therapeutic directed against PLK1, in
patients with advanced solid tumors" and discuss results from Tekmira's Phase
1 clinical trial with TKM-PLK1, which employs a unique lipid nanoparticle
developed for oncology applications.
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.
The Tekmira Pharmaceuticals logo is available at
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 are generally
identifiable by use of the words "believes," "may," "plans," "will,"
"anticipates," "intends," "budgets," "could," "estimates," "expects,"
"forecasts," "projects" and similar expressions, and the negative of such
expressions. Forward-looking statements in this news release include
statements about the expected timing of Phase 2 clinical trials for TKM-PLK1;
Tekmira's strategy, future operations, clinical trials, prospects and the
plans of management; RNAi (ribonucleic acid interference) product development
programs; and the effects of Tekmira's products on the treatment of cancer;
statements and details of the TKM-PLK1 Phase 1 human clinical trial.
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 Tekmira's
products as a treatment for cancer; results in preclinical models are
indicative of the potential effect in humans; Tekmira's research and
development capabilities and resources; FDA approval with respect to
commencing clinical trials; the timing and obtaining of regulatory approvals
for Tekmira's products; the time required to complete research and product
development activities; and Tekmira's ability to protect its intellectual
property rights and not to infringe on the intellectual property rights of
others. 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-PLK1 may never enter into Phase 2 clinical trials;
Tekmira's ability to obtain and protect intellectual property rights, and
operate without infringing on the intellectual property rights of others;
Tekmira's research and development capabilities and resources will not meet
current or expected demand; Tekmira's products may not prove to be effective
in the treatment of cancer; the possibility that other organizations have made
advancements in RNAi delivery technology that Tekmira is not aware of; the FDA
will not approve the commencement of Tekmira's planned clinical trials or
approve the use of Tekmira's products and generally, difficulties or delays in
the progress, timing and results of clinical trials; the FDA may determine
that the design and planned analysis of Tekmira's clinical trials do not
adequately address the trial objectives in support of Tekmira's regulatory
submissions; the release of data from the TKM-PLK1 Phase 1 human clinical
trial may not occur in the expected timeframe, or at all; pre-clinical and
clinical trials may be more costly or take longer to complete than
anticipated; pre-clinical or clinical trials may not generate results that
warrant future development of the tested drug candidate; and the possibility
that Tekmira has not 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 20-F for the year ended December
31, 2011 (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.
Tekmira Pharmaceuticals Logo
Press spacebar to pause and continue. Press esc to stop.