MISSISSAUGA, ON, Oct. 22, 2014 /PRNewswire/ - Nuvo Research Inc.
(TSX:NRI), a specialty pharmaceutical company with a diverse
portfolio of topical and immunology products, today announced the
results of a market study commissioned to investigate the U.S.
opportunity for the Company's experimental immunotherapy product,
WF10, as a treatment for patients with refractory allergic
rhinitis. The study, performed by Psscion Lifesciences
Consulting (Psscion), forecasts that WF10 could capture 10-15% of
the U.S. refractory allergic rhinitis market with peak U.S. annual
sales of US$0.7 billion to US$1.1
billion.
"This market study confirms the significant U.S. market
opportunity for WF10 to treat refractory allergic rhinitis," said
Dr. Henrich Guntermann, President of
Nuvo's Europe & Immunology
Group. "Our clinical and case study data suggests that WF10
is a revolutionary therapy that provides symptomatic relief from
multiple airborne allergens for up to 2 years after only 5 days of
treatment. We are eagerly awaiting results in Q1 2015 of our
ongoing 183 patient Phase 2 allergic rhinitis clinical study that
is designed to confirm the positive results achieved in our earlier
60 patient Phase 2 proof-of-concept study."
About The Psscion Study
The market study was conducted
by Psscion, a U.S. based firm that provides strategic advice and
market research to the pharmaceutical industry. Psscion was
retained to assist Nuvo in determining the optimum strategy to
maximize the value of WF10 for the treatment of refractory allergic
rhinitis. In the course of the study, Psscion interviewed
patients with refractory allergic rhinitis, practicing physicians
specializing as allergists and immunologists and representatives
from insurance companies and other payers. The additional
findings in the study were:
- Physicians were impressed by WF10's efficacy, long-lasting
therapeutic effect, ability to treat multiple allergens with one
dosing regimen and favourable safety profile as observed in the
Company's completed 60 patient Phase 2 proof-of-concept study and
case studies;
- Patients and physicians believe that WF10 would address an
unmet need in the treatment of refractory allergic rhinitis;
- WF10 could be an attractive alternative to subcutaneous
immunotherapy (SCIT) also known as "allergy shots" which are
allergen specific and can continue for months or years causing many
patients to either refuse or discontinue SCIT treatment; and
- Payers rated WF10 positively and felt that WF10 was unlikely to
face significant barriers to coverage.
About the Company's Ongoing WF10 Phase 2 Clinical
Trial
This 16 week clinical 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 allergic rhinitis patients
experiencing persistence or recurrence of symptomatic episodes in
spite of conventional treatment over the previous year. The
trial will measure total nasal symptom score (TNSS) and other
secondary endpoints. The trial is being conducted at 15 sites
in Germany. It is fully
enrolled with 183 patients participating. Top-line results
are expected in Q1 2015. The trial is designed to confirm the
results of the Company's 2010 60 patient, randomized, double-blind,
placebo-controlled, single-center Phase 2 clinical study of WF10
for the treatment of allergic rhinitis which achieved statistical
significance (P<0.001) for its primary endpoint (change in TNSS
at week 3).
About Refractory Allergic Rhinitis
Allergic rhinitis,
a highly prevalent condition characterized by nasal symptoms
(runny, blocked, or itchy nose; chronic sneezing) is triggered by
an inappropriate immune response to one or more allergens such as
pollens, house dust mites and pet dander. Refractory allergic
rhinitis patients often suffer from severe symptoms and do not
respond adequately to common forms of treatment such as
antihistamines and nasal corticosteroids. Most refractory
allergic rhinitis patients suffer from multiple allergies.
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
syndrome.
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 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 four 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.
About Psscion Lifesciences Consulting
Psscion
specializes in consulting services for the lifesciences sector.
Our people, approach and perspectives enable us to provide
exceptional results for client companies. Psscion delivers
marketing, commercialization strategy and corporate development
services that maximize R&D effectiveness, build differentiated
product value and achieve sustained market advantage for
pharmaceutical, biotech and medical technology companies.
Psscion partners with leading experts in a range of fields
including data analytics, health outcomes, reimbursement and
access, public relations and medical writing. For additional
information visit www.psscion.com.
Forward-Looking Statements
Certain statements in
this news 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 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.