MISSISSAUGA, ON, March 5, 2015 /CNW/ - Nuvo Research Inc.
(TSX:NRI), a specialty pharmaceutical company with a diverse
portfolio of topical and immunology products, today provided a
business update.
Immunology Group
On January 30,
2015, the Company announced topline results of its Phase 2
clinical trial to investigate the safety and efficacy of WF10™ in
patients with refractory allergic rhinitis (the 2014 Trial).
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 2010 Trial demonstrated statistical significance as measured
by the change in TNSS and TOSS comparing a WF10 group with a
placebo group at each of three, six, nine and twelve weeks after
treatment.
After reviewing the data from both trials and consulting
external experts, the Company believes that the 2010 Trial more
accurately illustrates the efficacy of WF10 in the treatment of
allergic rhinitis. It 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.
The 2014 Trial protocol provides for unblinded, follow-up
patient assessment that includes TNSS and TOSS assessments at six,
twelve, eighteen and twenty-four months after initial treatment.
The Company will be monitoring these data as they become
available at each measurement point.
The Company is also studying alternative next steps including
the option of conducting an additional confirmatory clinical study
which could be a field study in patients with seasonal allergies
and/or perennial allergies or an environmental exposure unit study
in which allergen exposure can be more readily controlled.
The Company will provide a further update once its strategy is
finalized.
The Company has taken steps to curtail spending on a number of
WF10 projects and studies planned for 2015 that were premised on
the 2014 Trial clearly confirming the positive results of the 2010
Trial.
The Company has posted a presentation on its website that
includes charts that detail TNSS and TOSS scores for the 2010 Trial
and the 2014 Trial.
Topical Products and Technology (TPT) Group
The
Company is focusing on maximizing the value of its topical products
group which includes the approved revenue generating products
Pennsaid®, Pennsaid 2%, Pliaglis and the heated
lidocaine/tetracaine patch (HLT Patch). Key recent
developments in the TPT Group include:
- Increasing Volumes of Pennsaid 2%. The Company supplies
Pennsaid 2% to Horizon Pharma plc (Horizon) for sale in the U.S.
under an exclusive manufacturing agreement. The most recent
prescription data provided by IMS Health indicates that Pennsaid 2%
prescriptions in the U.S. have increased to approximately 2,500 per
week compared to an average of approximately 1,200 per week in
December of 2014 – the last month that Pennsaid 2% was sold in the
U.S. by Nuvo's former Pennsaid 2% licensee. Horizon assumed
U.S. sales and marketing of Pennsaid 2% January 1, 2015.
- Pennsaid 2% Phase 3 Trial in Acute Pain. The Company
continues to plan for the commencement of a Phase 3 clinical trial
in Germany of Pennsaid 2% for the
treatment of acute pain. The trial will support regulatory
approval applications for Pennsaid 2% in international
jurisdictions. Commencement of the trial, which is subject to
German regulatory approval, is expected in Q2 2015 with topline
results anticipated in Q4 2015.
- NovaMedica Pennsaid 2% Clinical Study in Russia. NovaMedica LLC (NovaMedica), the
Company's licensee for Pennsaid 2% in Russia, has advised the Company that it has
commenced enrolling patients in a clinical study that is required
to obtain Russian regulatory approval. NovaMedica has advised
that it expects to receive regulatory approval and launch sales of
Pennsaid 2% in 2016.
- Pennsaid 2% Out Licensing Discussions. The Company has
commenced preliminary discussions with potential Pennsaid 2%
licensing partners for available international markets.
- Delivery of Topical Formulation to Ferndale. The Company
has completed and delivered its first topical formulation to
Ferndale Laboratories Inc. (Ferndale) utilizing the Company's
patented multiplexed molecular penetration enhancers (MMPE™)
technology. Under the terms of its collaboration with
Ferndale and a leading Contract Research Organization (CRO),
Ferndale and the CRO will oversee and fund the formulation's
advancement through Phase 2 clinical trials. It is
anticipated that the product will then be made available for out
licensing. Licensing revenues including upfront payments,
milestone payments and royalties will be shared with Nuvo based on
a calculation that includes compensation to Nuvo for contributing
the patented formulation.
Strategic Transactions
The Company has engaged Bloom
Burton & Co., a Toronto-based
investment bank, to assist in examining strategic transactions,
including a potential restructuring of the Company, with a view to
increasing shareholder value by obtaining better recognition of the
value of the Company's revenue generating assets and its cash
position, which as of December 31,
2014 was approximately $58
million.
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 the 2014 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 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.
About the 2010 WF10 Phase 2 Proof-of-Concept Clinical
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 Pennsaid 2%
Pennsaid 2% is a topical product
containing 2% diclofenac sodium compared to 1.5% for original
Pennsaid. It is approved in the U.S. for pain of
osteoarthritis (OA) of the knee(s). It is more viscous than
Pennsaid, is supplied in a metered dose pump bottle and has been
approved in the U.S. for twice daily dosing compared to four times
a day for Pennsaid. Pennsaid 2% is protected by 6 U.S. patents that
are listed in the FDA's Approved Drug Products with Therapeutic
Equivalence Evaluations database or Orange Book. Pennsaid 2%
has not yet received regulatory approval outside of the U.S.
Patents protecting Pennsaid 2% have been issued or are pending in
multiple major international territories.
About Pennsaid
Pennsaid is used to treat the signs and
symptoms of OA of the knee(s). The drug combines a
transdermal carrier (containing dimethyl sulfoxide, popularly known
as DMSO) with 1.5% diclofenac sodium, a non-steroidal
anti-inflammatory drug (NSAID) and delivers the active drug through
the skin directly to the site of inflammation and pain.
Effective January 1, 2015, Pennsaid
was no longer marketed in the U.S. It is currently marketed
in Canada by Paladin Labs Inc. and
marketed under license and/or distribution agreements in
Greece, Italy and the U.K.
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.
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 statements concerning
the Company's future objectives, strategies to achieve those
objectives, as well as statements with respect to management's
beliefs, plans, estimates, and intentions, 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 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.