MISSISSAUGA, ON, June 8, 2015 /PRNewswire/ - Nuvo Research
Inc. (TSX:NRI), a specialty pharmaceutical company with a diverse
portfolio of topical and immunology products, today announced it
has received Health Canada approval to conduct a new Phase 2
clinical trial (the 2015 WF10 Trial) to assess WF10 for the
treatment of allergic rhinitis.
The 2015 WF10 Trial will commence this month. It will be a
randomized, double-blind, placebo-controlled, single-center trial
to assess the efficacy, safety and tolerability of a regimen of
five WF10 infusions. The trial will enroll patients who have
a moderate to severe allergy to grass and ragweed pollen and will
build on learnings derived from previous WF10 allergic rhinitis
studies run in 2010 and 2014 (the 2010 WF10 Trial and 2014 WF10
Trial, respectively). Patients' symptoms have already been
recorded prior to commencement of the 2015 WF10 Trial in an
Environmental Exposure Chamber (EEC), and will be recorded in the
field during the grass and ragweed allergy seasons and again in the
EEC after completion of the ragweed season. The 2015 WF10
Trial is expected to enroll approximately 146 patients and to be
completed with topline results available in late Q4 2015 or early
Q1 2016. The trial will be conducted in southern Ontario, Canada by Inflamax Research Inc.
(Inflamax), a full service, specialty Contract Research
Organization (CRO) that specializes in allergy, respiratory and EEC
studies. Nuvo's external costs of conducting the trial will
be approximately CDN$5.0 million.
"We are excited to get this critical trial underway," said Dr.
Henrich Guntermann, President,
Europe & Immunology Group.
"The design of the new study includes a number of features
that differentiate it from our inconclusive 2014 WF10 Trial to
enhance the chance of a successful outcome including
(i) enrollment of larger numbers of patients per arm
(ii) the use of an EEC to fully-characterize patients prior to
entry into the study, (iii) a tight enrollment window to
ensure consistent patient exposure to allergens and (iv) the
use of electronic diaries to capture daily symptom scores. We
are optimistic that by the end of this year or early 2016, we will
have positive trial results that will support the further
development of WF10."
If the 2015 WF10 Trial is successful, the Company plans to
continue WF10 development in an independently financed entity that
will include the participation of Nuvo shareholders. While
Nuvo's management is optimistic that the 2015 WF10 Trial will
generate positive results, should the trial be unsuccessful, the
Company plans to discontinue WF10 development. The Company
has taken steps to curtail spending on a number of WF10 projects
and studies planned for 2015 until results of the 2015 WF10 Trial
are available.
About Inflamax Research Inc.
Headquartered in Toronto,
Ontario, Inflamax is a full service, global CRO specializing
in Proof of Concept, and Phase I through to Phase IV studies in
allergy, asthma, ocular, healthy volunteer studies and
dermatology. Inflamax Research is a world leader in conduct
and design of single and multi-center EEC and field allergy
studies. Inflamax has developed the supporting proprietary
clinical tools such as ePRO, ePDAT™, to improve data collection and
quality, and OCRUP™ for successful patient recruitment.
About Environmental Exposure Chambers
Inflamax's Environmental Exposure Chambers (EEC) are facilities
that are validated to tightly regulate temperature and humidity
while simulating the level of allergen exposure patients would
encounter in their everyday lives. By monitoring patients
throughout the exposure, nasal, bronchial and ocular symptoms and
signs may be evoked consistently and safely.
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.
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 the WF10 Trial conducted in 2014 (the 2014 WF10
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 trial 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. As anticipated,
the WF10 arm reduced allergy symptoms as evidenced by recorded
patient Total Nasal Symptom Scores (TNSS) and Total Ocular Symptom
Scores (TOSS). The placebo arm demonstrated an unexpectedly large
reduction in patient TNSS and TOSS scores that was greater than
those observed in the placebo arm in the Company's 2010 Phase 2
Proof-of-Concept clinical trial (the 2010 Trial). Moreover, in
contrast to the 2010 Trial, TNSS and TOSS scores in the placebo arm
declined at each successive time point in the 2014 Trial with no
tendency to revert towards baseline over time. While the WF10 arm
and the two separate arms that included constituent elements of
WF10 all performed better than the placebo arm, the differences
were not statistically significant. The Company believes that the
placebo group in the 2014 Trial did not record as high TNSS and
TOSS scores compared to the 2010 Trial due to a longer enrollment
period that started later in the allergy season, varying
environmental conditions and other factors that resulted in some
patients in the 2014 Trial not being exposed to a high enough
concentration of the allergens that they were allergic to
throughout the trial period.
About the WF10 Trial conducted in 2010 (the 2010 WF10
Trial)
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 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 currently has four commercial products, a pipeline of topical
and transdermal products focusing on pain and dermatology and
multiple 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 and an
immune system modulation platform that supports the development of
drug products that modulate chronic inflammation processes
resulting in a therapeutic benefit. 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
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not limited to statements concerning the Company's future
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and intentions, and similar statements concerning anticipated
future events, results, circumstances, performance or expectations
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"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 19, 2015 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 press 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 press release are qualified by these cautionary
statements. The forward-looking statements contained herein
are made as of the date of this press 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.