MISSISSAUGA, ON, Dec. 22, 2014 /CNW/ - Nuvo Research Inc. (TSX:
NRI), a specialty pharmaceutical company with a diverse portfolio
of immunology and topical products, today announced that the United
States Patent and Trademark Office (USPTO) has granted U.S. Patent
No. 8,911,797, relating to the use of formulations that include
chlorite ions (such as WF10) to treat or inhibit allergy-like
symptoms that include conjunctivitis in patients suffering from or
at risk of developing allergic asthma, allergic rhinitis or atopic
dermatitis. This is the Company's third issued U.S. patent that
relates to the treatment of allergic asthma, allergic rhinitis and
atopic dermatitis with WF10. The patent will expire in
2028.
"We are pleased that we have been able to secure additional U.S.
patent protection for WF10 in the field of allergic rhinitis," said
Dr. Henrich Guntermann, Nuvo's
President, Europe & Immunology
Group. "We are eagerly awaiting results from our 16-week,
double-blind, placebo-controlled, Phase 2 clinical trial to
investigate the safety and efficacy of WF10 in patients with
refractory allergic rhinitis. The patient treatment and
monitoring phase of the study has now been completed and we expect
to release top-line study results in mid-February of 2015."
About the Ongoing WF10 Phase 2 Clinical Trial
179
patients have completed the patient treatment and monitoring phase
of Nuvo's ongoing WF10 Phase 2 allergic rhinitis clinical trial
that commenced in March 2014 at 15
sites in Germany. 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 sensitized to multiple
airborne allergens who suffer from refractory allergic
rhinitis. The trial will measure total nasal symptom score
(TNSS), total ocular symptom score (TOSS) and other secondary
endpoints. The trial is designed to confirm the results of
the Company's 2010 Phase 2 WF10 proof-of-concept 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). It is 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 Allergic Conjunctivitis
Allergic conjunctivitis
is inflammation of the conjunctiva (the membrane covering the white
part of the eye) due to a variety of allergens which differ among
patients. Symptoms consist of redness (mainly due to
vasodilation of the peripheral small blood vessels), oedema
(swelling) of the conjunctiva, itching and increased lacrimation
(production of tears). If this is combined with rhinitis, the
condition is termed "allergic rhino conjunctivitis". The
symptoms are due to release of histamine and other active
substances by mast cells, which stimulate dilation of blood
vessels, irritate nerve endings, and increase secretion of
tears.
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 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 U.S. Food and Drug
Administration (FDA) approved 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.