Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM), a
leading developer of RNA interference (RNAi) therapeutics, today
announced an update on the TKM-Ebola Phase I clinical hold. The
Company has received the clinical hold letter from the U.S. Food
and Drug Administration (FDA) and is preparing a Complete Response
to the Agency. The Company anticipates this matter will be resolved
by Q4, 2014.
Tekmira's other clinical development programs are unaffected by
the TKM-Ebola clinical hold and all remain on track. The key
milestones for these programs in the second half of 2014 are:
- Presentation of TKM-HBV Pre-Clinical data
- Filing IND (or equivalent) for
TKM-HBV
- Interim Phase IIa TKM-PLK1 data
- Nomination of the next product development candidate
The clinical hold letter confirms that the FDA is seeking data
to elucidate the mechanism of potential cytokine release and a
modification to the protocol for the multiple ascending dose
portion of the trial to ensure the safety of healthy
volunteers.
"It is important to highlight that the study protocol for the
TKM-Ebola Phase I trial called for an interim review of the data
from the single ascending dose portion of the trial before
proceeding to the multiple ascending dose portion of the study. I
wish to emphasize this trial is unique. It represents the first
RNAi study involving the daily treatment of healthy volunteers,
without steroid pre-medication or any other type of pre-medication,
and with multiple ascending doses," said Dr. Mark Murray, President
and CEO of Tekmira Pharmaceuticals. "Furthermore, the multiple
ascending dose portion of the study, as originally proposed,
reflects the intense dosing regimen that would be used in patients
lethally infected with Ebola virus."
On May 21, 2014, the Company disclosed the results of the single
ascending dose portion of the study which demonstrated the
administration of TKM-Ebola in the absence of any
steroid-containing pre-medication was well-tolerated at a dose
level of 0.3 mg/kg, determined to be the maximum tolerated dose in
the absence of steroid cover. At that time, Dr. Murray said, "These
(TKM-Ebola Phase I) results are significant as they establish the
safety of 'third generation' LNP formulations and confirm that
dosing at efficacious levels may be accomplished without the need
for pre-medication."
The Company is assembling the data requested by the FDA and
shares its commitment to patient safety. Dr. Murray added, "The
mechanism for cytokine release is understood and we will be
modifying our study protocol to further ensure subject safety. Our
team is working expediently to respond to the FDA. We are mindful
of the need for this important therapeutic in situations such as
the ongoing Ebola outbreak in West Africa. However, TKM-Ebola is
currently an unapproved agent and the regulatory framework to
support its use in Africa has not been established at this
time."
The Company will provide a full business update at the upcoming
earnings release on August 13, 2014.
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 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 (LNP) 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 clinical hold on the
TKM-Ebola Phase I study by the FDA; Tekmira's preparation and
anticipated response to the FDA; the anticipated timeframe to
resolve the clinical hold by the fourth quarter; anticipated
milestones for Tekmira's other clinical development programs in the
second half of 2014, including presentation of TKM-HBV pre-clinical
data, filing an IND (or equivalent) for TKM-HBV by year end,
interim Phase IIa TKM-PLK-1 data, and nomination of the next
product development candidate; and a full business update at the
upcoming earnings release on August 13, 2014.
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 and the ongoing progress of Tekmira's other clinical
development programs. 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 complete a response to the FDA for the TKM-Ebola
Phase I trial in a timely manner; the FDA may not remove the
clinical hold on the TKM-Ebola Phase I trial in the timeframe
currently anticipated, and the TKM-Ebola Phase I trial may not
resume or complete as currently anticipated, or at all; Tekmira's
other clinical development programs may not meet expected
milestones in the timeframe currently anticipated, or at all; a
full business update may not be provided in the upcoming earnings
release; 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; and Tekmira may not receive the necessary regulatory
approvals for the clinical development of Tekmira's products.
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 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: 604-419-3200
Email: jrezler@tekmira.com
Media
Alan Bayless
Longview Communications Inc.
Phone: 604-694-6035
Email: abayless@longviewcomms.ca
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