- Results Expected Q1 2015
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MISSISSAUGA, ON, Sept. 3, 2014 /CNW/ - Nuvo Research Inc.
(TSX:NRI), a specialty pharmaceutical company with a diverse
portfolio of topical and immunology products, today announced that
it has completed enrolment in its Phase 2 clinical trial to
investigate the safety and efficacy of WF10 in patients with
refractory allergic rhinitis. The Company expects the trial
to be completed in late 2014 with top-line results anticipated in
the first quarter of 2015.
"This study's goal is to expand upon the successful results
attained with WF10 in our first Phase 2 allergic rhinitis
study. In that study we saw a statistically significant
reduction in allergy scores for patients treated with WF10 as
compared to placebo," said Henrich
Guntermann, President, Europe & Immunology Group. "Having
now completed enrolment in our second larger multi-center Phase 2
study, we move closer to generating further evidence of WF10's
potential benefit for allergy sufferers whose disease is not
adequately controlled with existing therapies."
WF10 Phase 2 Clinical Trial
Treatment of patients in
the WF10 Phase 2 allergic rhinitis clinical trial commenced in
March 2014. The trial is fully enrolled at 15 sites in
Germany. Enrolment was slowed by weather conditions in the
second quarter of 2014 resulting in a decreased exposure of
patients to pollens and lower incidence of allergic rhinitis
symptoms. The 16-week trial is a randomized, double-blind,
placebo-controlled study to assess the efficacy, safety and
tolerability of a regimen of five infusions of either WF10 or its
main constituents (sodium chlorite and sodium chlorate) relative to
saline control in patients with multiple airborne allergies who
suffer from moderate to severe allergic rhinitis. The trial
will measure total nasal symptom score (TNSS) and other secondary
endpoints. The trial is designed to confirm the results of
the Company's 2010 Phase 2 WF10 clinical trial for the treatment of
allergic rhinitis which achieved statistical significance
(P<0.001) for its primary endpoint (change in TNSS at week
3).
Allergic Rhinitis and Refractory Allergic
Rhinitis
Allergic rhinitis is a highly prevalent condition
characterized by nasal symptoms (runny, blocked, or itchy nose;
chronic sneezing) triggered by an inappropriate immune response to
one or more allergens such as pollens, house dust mites and pet
dander. Refractory allergic rhinitis patients usually show a
strong degree of symptom incidence and do not respond adequately to
common forms of treatment. It is estimated that there are 82
million allergy patients in the United
States of which approximately 10 million suffer from
allergic rhinitis that is refractory.
WF10
The immune system provides an essential defense
to microorganisms, cancer and substances it sees as foreign and
potentially harmful. In conditions such as allergic rhinitis,
the body's immune system inappropriately responds to the presence
of foreign allergens. Research suggests that in some cases,
WF10 may rebalance improperly functioning immune systems.
WF10 is an infusion therapy currently approved only in Thailand under the name IMMUNOKINE for the
treatment of post-radiation-therapy syndromes and diabetic foot
ulcers. WF10 is not yet approved for the treatment of
moderate to severe allergic rhinitis.
About Nuvo Research Inc.
Nuvo (TSX:NRI) is a specialty
pharmaceutical company with a diverse portfolio of products and
technologies. The Company operates two distinct business
units: the Topical Products and Technology (TPT) Group and the
Immunology Group. The TPT Group has four U.S. Food and Drug
Administration (FDA) approved commercial products, a pipeline of
topical and transdermal products focusing on pain and dermatology
and four drug delivery platforms that support the development of
patented formulations that can deliver actives into or through the
skin. The Immunology Group has two commercial products, a
development program for the treatment of allergic rhinitis and an
immune system modulation platform that has the potential to support
treatments for a broad range of immune system related
disorders. For additional company information visit
www.nuvoresearch.com.
Forward-Looking Statements
Certain statements in
this news release constitute forward-looking statements within the
meaning of applicable securities laws. Forward-looking statements
include, but are not limited to the Company's anticipated use of
proceeds from the Private Placement, the Company's future share
price and the Company's possible election to accelerate the expiry
date of any of the warrants or the brokers warrants and similar
statements concerning anticipated future events, results,
circumstances, performance or expectations that are not historical
facts. Forward-looking statements generally can be identified by
the use of forward-looking terminology such as "outlook",
"objective", "may", "will", "expect", "intend", "estimate",
"anticipate", "believe", "should", "plans" or "continue", or
similar expressions suggesting future outcomes or events. Such
forward-looking statements reflect management's current beliefs and
are based on information currently available to management.
Forward-looking statements involve risks and uncertainties that
could cause actual results to differ materially from those
contemplated by such statements. Factors that could cause such
differences include general business and economic uncertainties and
adverse market conditions as well as other risk factors included in
the Company's Annual Information Form dated February 20, 2014 under the heading "Risks
Factors" and as described from time to time in the reports and
disclosure documents filed by the Company with Canadian securities
regulatory agencies and commissions. This list is not exhaustive of
the factors that may impact the Company's forward-looking
statements. These and other factors should be considered carefully
and readers should not place undue reliance on the Company's
forward-looking statements. As a result of the foregoing and other
factors, no assurance can be given as to any such future results,
levels of activity or achievements and neither the Company nor any
other person assumes responsibility for the accuracy and
completeness of these forward-looking statements. The factors
underlying current expectations are dynamic and subject to change.
Although the forward-looking information contained in this news
release is based upon what management believes are reasonable
assumptions, there can be no assurance that actual results will be
consistent with these forward-looking statements. All
forward-looking statements in this news release are qualified by
these cautionary statements. The forward-looking statements
contained herein are made as of the date of this news release and
except as required by applicable law, the Company undertakes no
obligation to publicly update or revise any forward-looking
statement, whether as a result of new information, future events or
otherwise.
SOURCE Nuvo Research Inc.