MISSISSAUGA, ON, April 22, 2015 /CNW/ - Nuvo Research Inc.
(TSX:NRI), a specialty pharmaceutical company with a diverse
portfolio of topical and immunology products, today announced
additional details of its new Phase 2 clinical trial (the 2015 WF10
Trial) to assess WF10 for the treatment of allergic rhinitis.
The 2015 WF10 Trial 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. Patients' symptoms will
be recorded prior to commencement of the grass allergy season in an
Environmental Exposure Chamber (EEC), in the field throughout 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.
Commencement of the 2015 WF10 Trial is subject to regulatory
approval by Health Canada.
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.
"This is a critical trial to the future of WF10," said Dr.
Henrich Guntermann, President,
Europe & Immunology Group.
"It is designed to increase the likelihood that patients are
exposed to sufficient concentrations of allergens to which they are
allergic. We believe that a lack of allergen exposure led to
inconclusive results in our 2014 Phase 2 clinical trial and we
expect that the results of this new trial will more closely compare
to the positive results from our 2010 clinical trial."
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, 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.
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February 19, 2015 under the heading
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SOURCE Nuvo Research Inc.