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 the publication of preclinical data highlighting
positive results against Ebola virus Makona infection using a newly
adjusted siRNA cocktail. The paper is titled,
"Lipid
Nanoparticle siRNA Treatment of Ebola Virus Makona-infected
Nonhuman Primates," (Thi et al., Nature April 22, 2015,
doi:10.1038/nature14442).
Tekmira, along with its collaborators at the University of Texas
Medical Branch at Galveston, USA, jointly conducted a preclinical
study demonstrating 100% survival of nonhuman primates infected
with the West Africa Makona strain of Ebola virus, previously
referred to as the Guinea strain. Complete survival was observed
even when treatment did not begin until three days after viral
exposure, a time point at which animals were five to six days away
from death.
"We are pleased to report these preclinical efficacy results. As
far as we are aware, these data are the first successful
demonstration of anti-Ebola virus therapeutic efficacy against the
Makona strain in nonhuman primates," said Dr. Mark Murray,
Tekmira's President and CEO. "These results underscore the
adaptability of our siRNA-LNP technology in response to emerging
infections. In this case, we rapidly went from new viral sequence
data availability, to clinical product adapted to the new Makona
strain."
TKM-Ebola-Guinea (targeting the Makona strain), containing the
adjusted siRNA cocktail used in the pre-clinical study, is
currently being evaluated in a Phase II clinical study in Sierra
Leone with results expected in the second half of 2015. The study
is being conducted by the University of Oxford on behalf of the
International Severe Acute Respiratory and Emerging Infection
Consortium (ISARIC), with funding by the Wellcome Trust.
About TKM-Ebola-Guinea, an Anti-Ebola RNAi Therapeutic
Targeting Ebola-Guinea
The Ebola virus Makona variant responsible for the current
outbreak in West Africa shows sequence divergence from Central
African Ebola virus variants, the original target of TKM-Ebola. The
genomic sequence of Ebola virus Makona was determined from several
viral isolates and published in the New England Journal of Medicine
in October 2014. Tekmira developed a modified RNAi therapeutic,
based on the Company's original TKM-Ebola investigational
therapeutic, to specifically target the Makona variant. The new
product, termed TKM-Ebola-Guinea, is designed to match the genomic
sequence exactly, with two RNAi triggers. The ability to rapidly
and accurately match the evolving genetic sequences of emerging
infectious agents is one of the powerful features of RNAi
therapeutics.
About University of Texas Medical Branch
Texas' first academic health center opened its doors in 1891 and
today comprises four health sciences schools, three institutes for
advanced study, a research enterprise that includes one of only two
national laboratories dedicated to the safe study of infectious
threats to human health, and a health system offering a full range
of primary and specialized medical services throughout Galveston
County and the Texas Gulf Coast region. UTMB Health is a component
of the University of Texas System and a member of the Texas Medical
Center.
About Oxford University's Medical Sciences
Division
Oxford University's Medical Sciences Division is one of the
largest biomedical research centres in Europe, with over 2,500
people involved in research and more than 2,800 students. The
University is rated the best in the world for medicine, and it is
home to the UK's top-ranked medical school. From the genetic and
molecular basis of disease to the latest advances in neuroscience,
Oxford is at the forefront of medical research. It has one of the
largest clinical trial portfolios in the UK and great expertise in
taking discoveries from the lab into the clinic. Partnerships with
the local NHS Trusts enable patients to benefit from close links
between medical research and healthcare delivery. A great strength
of Oxford medicine is its long-standing network of clinical
research units in Asia and Africa, enabling world-leading research
on the most pressing global health challenges such as malaria, TB,
HIV/AIDS and flu. Oxford is also renowned for its large-scale
studies which examine the role of factors such as smoking, alcohol
and diet on cancer, heart disease and other conditions.
About Wellcome Trust
The Wellcome Trust is a global charitable foundation dedicated
to improving health. It provides more than £700 million a year to
support bright minds in science, the humanities and the social
sciences, as well as education, public engagement and the
application of research to medicine. Its investment portfolio
provides independence to support such transformative work as
the sequencing and understanding of the human genome, research that
established front-line drugs for malaria, and Wellcome Collection,
its free venue for the incurably curious that explores medicine,
life and art. www.wellcome.ac.uk.
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 other
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 adapting
a pre-existing siRNA drug to emerging viral strains and
manufacturing a clinical product in as little as eight weeks; the
expectation of results in the second half of 2015 from a
TKM-Ebola-Guinea Phase II clinical study in Sierra Leone; 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: the continued approval of the FDA; the
effectiveness of pre-clinical and clinical studies; and continued
economic and market stability. 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: the FDA
may place restrictions on further clinical trials; other
organizations may 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 may
worsen.
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.
CONTACT: Investors
Adam Cutler
Senior Vice President, Corporate Affairs
Phone: 604.419.3200
Email: acutler@tekmira.com
Julie P Rezler
Director, Investor Relations
and Corporate Communications
Phone: 604.419.3200
Email: jrezler@tekmira.com
Media
Please direct all media inquiries to media@tekmira.com
Arbutus Biopharma (NASDAQ:ABUS)
Historical Stock Chart
From Mar 2024 to Apr 2024
Arbutus Biopharma (NASDAQ:ABUS)
Historical Stock Chart
From Apr 2023 to Apr 2024