- Nuvo to Host Conference Call/Webcast
at 8:30 a.m. ET -
MISSISSAUGA, ON, Jan. 30, 2015 /PRNewswire/ - Nuvo Research Inc.
(TSX:NRI), a specialty pharmaceutical company with a diverse
portfolio of topical and immunology products, today announced the
results of its 16-week, double-blind, placebo-controlled, Phase 2
clinical trial conducted in Germany to compare the safety and efficacy of
WF10 and its main constituents (sodium chlorite and sodium
chlorate) with saline in patients with refractory allergic rhinitis
and to compare the safety and efficacy of WF10 and its main
constituents. The study included three active arms (the Active
Arms): a) WF10; b) WF10 with chlorate and sulphate removed; and c)
WF10 with chlorite and sulphate removed. Each of the Active Arms
was compared to a placebo arm in which patients received saline.
Active or placebo treatments were administered by five intravenous
infusions given once per day during the first five days of the
study. The primary endpoint was change in Total Nasal Symptom Score
(TNSS) from baseline to assessment after three weeks. TNSS is a
validated scale to measure nasal symptoms associated with allergic
rhinitis.
Topline Findings of the Study are:
- The WF10 arm demonstrated a reduction in TNSS over the course
of the observation period, similar to the reduction in TNSS
demonstrated in the WF10 arm in the Company's previous 2010 Phase 2
proof-of-concept study described further below.
- The placebo arm demonstrated a reduction in TNSS over the
course of the observation period that was significantly greater
than demonstrated in the placebo arm of the Company's 2010 Phase 2
proof-of-concept study.
- Each of the Active Arms demonstrated a greater reduction in
TNSS than placebo; however, (i) the difference between the WF10 arm
and the placebo arm did not achieve statistical significance 3
weeks after commencement of the study which was the study's primary
endpoint and (ii) the difference between the Active Arms and the
placebo arm did not achieve statistical significance at measured
time points over the course of the observation period.
- Treatments administered in the Active Arms were well tolerated
with favourable safety profiles.
The Company is conducting a detailed review of the data and
expects to release further information and analysis of the data
including information on secondary endpoints in the coming
weeks.
"While the WF10 arm performed as expected, the placebo arm
demonstrated a much greater than anticipated reduction in allergy
symptom scores," said Dr. Henrich
Guntermann, President, Europe & Immunology Group. "The cold and
wet allergy season in Germany may
have reduced symptoms for all patients in the study and possibly
impacted the difference in symptoms between the WF10 arm and the
placebo arm. We are conducting a more detailed analysis of the data
which we will report when it becomes available."
About the WF10 Phase 2 Clinical Trial
184 patients were enrolled in and 179 patients completed the
WF10 Phase 2 allergic rhinitis clinical trial that commenced in
March 2014 at 15 sites in
Germany. The 16-week trial was 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 who suffer from
refractory allergic rhinitis with positive skin test to at least
one allergen. 46 patients were enrolled in each of 4 arms to
receive WF10, WF10 with chlorate removed, WF10 with chlorite
removed or placebo (saline). The trial measured total nasal symptom
score (TNSS), total ocular symptom score (TOSS) and other secondary
endpoints. The trial was designed to confirm the results of the
Company's 2010 Phase 2 WF10 proof-of-concept clinical trial for the
treatment of allergic rhinitis with WF10 which achieved statistical
significance (P<0.001) for its primary endpoint (change in TNSS
at week 3). It was also designed to provide information on which
WF10 constituent elements are contributing to its therapeutic
benefit.
About the 2010 WF10 Phase 2 Proof-of-Concept Study
In 2010, the Company conducted a Phase 2 proof-of-concept
clinical trial to evaluate WF10 as a treatment for persistent
allergic rhinitis. The trial was a 60-subject, randomized,
double-blind, placebo-controlled, single-center trial to assess the
efficacy and safety of a regimen of five WF10 infusions. The trial
met its primary endpoint as measured by the change in Total Nasal
Symptom Score (TNSS) from baseline to assessment after three weeks
comparing the WF10 group with the placebo group. The trial also met
its secondary endpoints as measured by the change in TNSS at six,
nine and twelve weeks and in the Total Ocular Symptom Score (TOSS)
from baseline to assessment after three, six, nine and twelve
weeks. The TNSS and TOSS are validated scales to measure nasal and
ocular symptoms associated with allergic rhinitis. The results were
statistically significant for all primary and secondary endpoints
with p-values less than 0.001 except for the change in TOSS after
three weeks for which the p-value was less than 0.003. WF10 was
very well tolerated and there were few reported adverse events.
About 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 strong symptoms
and do not respond adequately to common forms of treatment such as
antihistamines or inhaled corticosteroids. 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.
About WF10
WF10 is a solution containing stabilized chlorite ions that
focuses on supporting the immune system by targeting the
macrophage, a type of white blood cell that coordinates much of the
immune system, to regulate normal immune function. WF10 is an
infusion therapy currently approved only in Thailand under the name IMMUNOKINE for the
treatment of post-radiation-therapy syndromes and adjunctive
therapy of diabetic foot ulcers.
Management to Host Conference Call/Webcast
Management will host a conference call to discuss the results
from the WF10 Phase 2 trial today (January
30, 2015) at 8:30 a.m. ET. To
participate in the conference call, please dial 1 (888) 231-8191 or
(647) 427-7450, reference number 78033834. Please call in 15
minutes prior to the call to secure a line. You will be put on hold
until the conference call begins.
A taped replay of the conference call will be available two
hours after the live conference call and will be accessible until
Friday, February 6, 2015 by calling 1
(855) 859-2056 or (416) 849-0833, reference number
78033834.
A live audio webcast of the conference call will be available
through www.nuvoresearch.com. Please connect at least 15 minutes
prior to the conference call to ensure adequate time for any
software download that may be required to hear the webcast.
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 Immunology Group and the
Topical Products and Technology (TPT) Group. 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. The TPT Group currently
has four commercial products, a pipeline of topical and transdermal
products focusing on pain and dermatology and two drug delivery
platforms that support the development of patented formulations
that can deliver actives into or through the skin. For additional
company information visit www.nuvoresearch.com.
Forward-Looking Statements
Certain statements in this press 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 sale
of Pennsaid 2% U.S. rights to Horizon Pharma plc, the litigation
settlement with Mallinckrodt Inc. and from the March 2014 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.