Revive Therapeutics Ltd. Announces Positive Results of REV-001
Phase 2A Proof-Of-Concept Study
TORONTO, ONTARIO--(Marketwired - Jun 27, 2014) - Revive
Therapeutics Ltd. (TSX-VENTURE:RVV) ("Revive") announced today
positive results from the second-half of its Phase 2a
proof-of-concept study (the "Study") of REV-001 targeted for the
treatment and/or prevention of opioid-induced respiratory
depression for patients with sleep apnea in a post-operative
setting.
The purpose of the Study is to determine the effect of an oral
dose of REV-001 on alfentanil-induced respiratory depression and
analgesia. The results of the Study indicate that a single dose of
REV-001 may treat and/or prevent opioid induced respiratory
depression in a post-operative setting, without affecting
analgesia. The 16-patient, placebo-controlled, double-blind,
randomized two-way crossover trial was performed by one of the
leading experts in the field, Professor Dr. Albert Dahan, M.D.,
Ph.D., at the Leiden University Medical Center in The Netherlands.
Full results of the Study to be published.
The data from the second-half of the Study in the eight patients
yielded the following key findings:
- Treatments with REV-001 was safe and well tolerated at the 50
mg dose, was not associated with serious adverse events, and there
was no treatment-related discontinuations;
- A significant increase on respiratory drive as measured by
inspired minute ventilation at an elevated expired PCO2 (VE55) of
36% (p = 0.039) by REV-001 as compared to placebo during high-dose
alfentanil infusion induced respiratory depression;
- Treatments with REV-001 did not affect the opioids analgesic
properties; and
- Treatments with REV-001 did not affect sedation.
"Overall, this is a successful study showing the respiratory
stimulatory effects of REV-001, that now seems to have a novel
target, that is reversal of opioid-induced respiratory depression
and a unique solution in a post-operative setting," said Prof. Dr.
Albert Dahan M.D., Ph.D., Principal Study Investigator and
Professor of Anesthesiology at the Leiden University Medical
Center, The Netherlands.
"I am very pleased with the successful completion of our first
human clinical trial and that we met our milestone for REV-001 on
time and on budget. The positive results of the REV-001 human
clinical trial now positions the drug for partnering discussions,"
said Fabio Chianelli, Revive's Chief Executive Officer. "This
achievement not only validates our ability to successfully
repurpose drugs for new indications, but also provides us with the
opportunity to advance our business development activities via
licensing and acquisitions."
About Post-Operative Pain and Sleep Apnea
According to the National Center for Health Statistics, there
are over 100 million surgeries performed annually in the United
States with approximately 50% of those requiring post-operative
pain medication such as opioids. However, opioids are known to
raise serious concerns such as respiratory depression, oxygen
desaturation and other side effects such as constipation, nausea
and vomiting. Patients who have obstructive sleep apnea (OSA) are
at a particular risk of experiencing such negative side-effects
from opioids. There are 18 million Americans with sleep apnea and
the condition is exacerbated with age, obesity, smoking and
alcohol. According to an article titled "A Rude Awakening - The
Perioperative Sleep Apnea Epidemic" published in the New England
Journal of Medicine in June 2013, the risk of perioperative
complications increase substantially with those who have OSA.
Hospitals must take into consideration the financial implications
that may become prevalent for patients who have OSA in order to
reduce the risk of adverse events, such as opioid-induced
respiratory depression. It has been estimated that between 29% and
41% are at high risk of opioid-induced respiratory depression.
(Source: Hanna MH et al. Anesthesiology. 2005;102(4): 815-821 and
Overdyk FK et al. Anesth Analg. 2007;105(2): 412-418). Currently,
there are no approved drugs for OSA and the only drug treatments to
counter opioid-induced respiratory depression is to administer
opiate receptor antagonists such as naloxone (Narcan®). However,
those antagonists eliminate the analgesic activity of the opioid
drug and thus are rarely used by hospitals and healthcare
facilities to prevent or treat opioid-induced respiratory
depression. According to the article "A Rude Awakening - The
Perioperative Sleep Apnea Epidemic", perioperative sleep apnea in
the United States has been considered as an 'Epidemic'.
About REV-001
REV-001 is the repurposing of the drug tianeptine, an old but
unique anti-depressant drug, which is marketed in Asia, parts of
Europe and South America. Despite its narrow geographic scope, the
decades-long clinical experience of tianeptine suggests much about
its safety. In fact, tianeptine has been shown to have substantial
cardiovascular and other safety at both normal doses and in
overdose. (Source: Wilde, M. I. & Benfield, P. Drugs 49,
411-439 (1995)). More recently, in animal studies conducted by
Revive, tianeptine was shown for the first time to prevent
opioid(morphine)-induced respiratory depression in an animal model.
The novel findings in Revive's animal studies enabled Revive to
apply for intellectual property protection covering the use of
tianeptine to treat respiratory depression.
About Revive Therapeutics Ltd.
Revive Therapeutics Ltd. is a Canadian public company
(TSX-VENTURE:RVV) focused on acquiring, developing and
commercializing treatments for major market opportunities such as
gout, post-operative pain, and rare diseases. Revive aims to bring
drugs to market by finding new uses for old drugs, also known as
drug repurposing, and improving the therapeutic performance of
existing drugs for underserved medical needs. Additional
information on Revive is available at www.revivethera.com.
The information in this news release includes certain
information and statements about management's view of future
events, expectations, plans and prospects that constitute forward
looking statements that may not be based on historical fact,
including without limitation statements containing the words
"believe", "may", "plan", "will", "estimate", "continue",
"anticipate", "intend", "expect" and similar expressions. These
statements are based upon assumptions that are subject to
significant risks and uncertainties. Because of these risks and
uncertainties and as a result of a variety of factors, the actual
results, expectations, achievements or performance may differ
materially from those anticipated and indicated by these forward
looking statements. Such factors include, among others, Revive's
stage of development, lack of any product revenues, additional
capital requirements, risk associated with the completion of
clinical trials and obtaining regulatory approval to market
products, the ability to protect intellectual property, dependence
on business partners and the prospects for negotiating joint
ventures, distribution and licensing arrangements and their timing.
Specifically, certain risks and uncertainties that could cause such
actual events or results expressed or implied by such
forward-looking statements and information to differ materially
from any future events or results expressed or implied by such
statements and information include, but are not limited to; the
risks and uncertainties that Revive may not be able to successfully
develop and obtain regulatory approval for its products;
intellectual property disputes; future operating results are
uncertain and likely to fluctuate; ability to raise additional
capital; successfully establishing additional corporate
collaborations, distribution or licensing arrangements;
establishing marketing and the costs of launching products may be
restricting; Revive's lack of experience in commercial
manufacturing; increased competition from pharmaceutical and
biotechnology companies; and other factors as described in detail
in Revive's filings on SEDAR (www.sedar.com), including, without
limitation, Revive's Filing Statement dated November 26, 2013 filed
on SEDAR on November 27, 2013. Given these risks and uncertainties,
readers are cautioned not to place undue reliance on such
forward-looking statements and information, which are qualified in
their entirety by this cautionary statement. Although Revive
believes that the expectations reflected in forward looking
statements are reasonable, it can give no assurances that the
expectations of any forward looking statements will prove to be
correct. Except as required by law, Revive disclaims any intention
and assumes no obligation to update or revise any forward looking
statements to reflect actual results, whether as a result of new
information, future events, changes in assumptions, changes in
factors affecting such forward looking statements or
otherwise.
Neither TSX Venture Exchange nor its Regulation Services
Provider (as that term is defined in the policies of the TSX
Venture Exchange) accepts responsibility for the adequacy or
accuracy of this release.
Revive Therapeutics Ltd.Fabio ChianelliChief Executive
Officer905-605-5535 (ext.
10)fabio@revivethera.comwww.revivethera.com
Revive Therapeutics (TSXV:RVV)
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