Tekmira Receives Notice of Clinical Hold for TKM-Ebola Phase I Clinical Trial
July 03 2014 - 3:15AM
Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM), a
leading developer of RNA interference (RNAi) therapeutics, today
announced that the Company has received verbal notice from the U.
S. Food and Drug Administration (FDA) that the TKM-Ebola Phase I
healthy volunteer clinical study has been placed on clinical hold.
This notice applies only to this study.
"We have completed the single ascending dose portion of this
study in healthy volunteers without the use of steroid
pre-medication. The FDA has requested additional data related to
the mechanism of cytokine release, observed at higher doses, which
we believe is well understood, and a protocol modification designed
to ensure the safety of healthy volunteer subjects, before we
proceed with the multiple ascending dose portion of our TKM-Ebola
Phase I trial," said Dr. Mark Murray, President and CEO of Tekmira
Pharmaceuticals. "We will continue our dialogue with the FDA,
provided for under our Fast Track status, in order to advance the
development of this important therapeutic agent."
About the TKM- Ebola Phase I Clinical Trial
The TKM-Ebola Phase I clinical trial is a randomized,
single-blind, placebo-controlled study and involves single
ascending doses and multiple ascending doses of TKM-Ebola. The
study is assessing the safety, tolerability and pharmacokinetics of
administering TKM-Ebola to healthy adult volunteers without
administering any steroid pre-medications.
About TKM-Ebola, an Anti-Ebola Virus RNAi
Therapeutic
TKM-Ebola, an anti-Ebola virus RNAi therapeutic, is being
developed under a $140 million contract with the U.S. Department of
Defense's Medical Countermeasure Systems BioDefense Therapeutics
(MCS-BDTX) Joint Product Management Office. Earlier preclinical
studies were published in the medical journal The Lancet and
demonstrated that when siRNA targeting the Ebola virus and
delivered by Tekmira's LNP technology were used to treat previously
infected non-human primates, the result was 100 percent protection
from an otherwise lethal dose of Zaire Ebola virus (Geisbert et
al., The Lancet, Vol 375, May 29, 2010). In March 2014, Tekmira was
granted a Fast Track designation from the U.S. Food and Drug
Administration for the development of TKM-Ebola.
About Joint Project Manager Medical Countermeasure
Systems (JPM-MCS)
This work is being conducted under contract with the U.S.
Department of Defense Joint Project Manager Medical Countermeasure
Systems (JPM-MCS). JPM-MCS, a component of the Joint Program
Executive Office for Chemical and Biological Defense, aims to
provide U.S. military forces and the nation with safe, effective,
and innovative medical solutions to counter chemical, biological,
radiological, and nuclear threats. JPM-MCS facilitates the advanced
development and acquisition of medical countermeasures and systems
to enhance our nation's biodefense response capability. For more
information, visit www.jpeocbd.osd.mil.
About Tekmira
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.tekmira.com. Tekmira is based in Vancouver, B.C.
Canada.
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; the verbal notice from the
FDA that a clinical hold has been placed on the TKM-Ebola Phase I
Clinical Trial; and RNAi (ribonucleic acid interference) product
development programs.
With respect to the forward-looking statements contained in this
news release, Tekmira has made numerous assumptions regarding,
among other things, the resumption and completion of the TKM-Ebola
Phase I trial. 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
may not be able to provide additional data and protocol
modifications to the FDA for the TKM-Ebola Phase I trial in a
timely manner, or at all; the TKM-Ebola Phase I trial may not
resume or complete as currently anticipated, or at all; 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; 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; Tekmira may not
receive the necessary regulatory approvals for the clinical
development of Tekmira's products; and anticipated payments under
contracts with Tekmira's collaborative partners may not be received
by Tekmira on a timely basis, or at all, or in the quantum expected
by Tekmira.
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 or 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
Julie P. Rezler
Director, Investor Relations
Phone: 604-419-3234
Email: jrezler@tekmira.com
Media
Alan Bayless
Longview Communications Inc.
Phone: 604-694-6035
Email: abayless@longviewcomms.ca
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