- Study fails to demonstrate separation
between WF10 and placebo -
- Company will discontinue development
of WF10 and focus on other pipeline products -
- Nuvo to Host Conference Call/Webcast at
8:30 a.m. ET Today -
MISSISSAUGA, ON, Dec. 21, 2015 /CNW/ - Nuvo Research Inc.
(TSX:NRI), a life sciences company with growing revenues and a
diverse portfolio of topical products, today announced the results
of its investigational Phase 2 clinical trial of WF10 (Trial) for
the treatment of allergic rhinitis.
Study Results and Company Strategy
Patients dosed with WF10 did not report a reduction in symptoms
that was significantly better than patients dosed with a saline
placebo at any of the endpoints being measured in the study.
There was no significant difference in the performance of
WF10 relative to placebo when patients were exposed to grass and
ragweed pollen in the Environmental Exposure Chamber (EEC) or when
they were exposed to naturally occurring allergens during the field
portion of the study.
The Company believes that the results are not sufficient to
justify the further development of WF10 for the treatment of
allergic rhinitis and plans to discontinue all WF10 development.
The Company has a strong balance sheet and these results do
not affect the Company's previously announced plans to split Nuvo
into two separate, publicly traded companies. Under the
proposed plan, one company, to be known as Nuvo Pharmaceuticals
Inc. (Nuvo Pharma), will be a commercial healthcare company that
will own the Company's Pennsaid and Pennsaid 2% franchises and
related assets, and is expected to generate revenue, positive
EBITDA and positive net earnings. The other company, to be
known as Crescita Therapeutics Inc. (Crescita), will be a drug
development company that will own the Company's existing drug
development business, including the topical product candidates
Flexicaine for the treatment of diabetic peripheral neuropathy,
IBUFOAM for the treatment of acute and chronic pain and
Onychomycosis Solution for the treatment of onychomycosis, all of
which target sizeable market opportunities. Nuvo's
shareholders will own 100% of both companies at the time of the
split.
"The results of this study make it clear that we should focus
our R&D resources on advancing our very promising topical
product candidates rather than WF10," said Dan Chicoine, Nuvo's Chairman and Co-CEO.
"We have developed specific strategies and are refining
development timelines for the advancement of each of these product
candidate and plan to finalize and outline the details in Q1
2016."
About the Trial
The Trial commenced enrolment of patients with moderate to
severe allergy to grass and ragweed pollen in June of this
year. The Trial was a randomized, double-blind,
placebo-controlled, single-centre trial to assess the efficacy,
safety and tolerability of a regimen of five WF10 infusions.
A total of 72 patients completed the Trial. Patients'
symptoms were recorded prior to commencement of the grass allergy
season in an EEC and symptoms were recorded in the field throughout
the grass and ragweed allergy seasons and again in the EEC after
completion of the ragweed season. The Trial was 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.
About Flexicaine
Flexicaine is a proprietary patent-protected cream formulation
of lidocaine and tetracaine that is designed for the topical
treatment of pain conditions such as post herpetic neuralgia or
diabetic peripheral neuropathy. The formulation dries to form
a film which can be easily peeled from the skin once actives have
been delivered to the site of pain providing a long-lasting
anesthetic effect and simple removal of the product.
About IBUFOAM
IBUFOAM targets the treatment of acute and chronic pain
conditions such as sprains and strains and osteoarthritis.
IBUFOAM is a topical ibuprofen foam formulation that combines the
transdermal carrier DMSO, pioneered in Nuvo's Pennsaid products,
with 5% of the NSAID ibuprofen and delivers the active drug through
the skin directly to the site of inflammation and pain. This
product is protected by a patent recently granted by the US Patent
and Trademark Office (USPTO).
About Onychomycosis Solution
Onychomycosis Solution is a 10% terbinafine solution developed
for topical treatment of onychomycosis, a fungal infection of the
nail which is reported to be prevalent in up to 14% of the
population in North America. This pipeline candidate is
protected by a patent recently granted by the USPTO.
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. The CRO 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 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.
Management to Host Conference Call/Webcast
Management will host a conference call to discuss the results
from the WF10 Phase 2 trial today (December
21, 2015) at 8:30 a.m. ET.
To participate in the conference call, please dial 1 (888)
231-8191 or (647) 427-7450, reference number 14128725. Please
call in 15 minutes prior to the call to secure a line. You will be
put on hold until the conference call begins.
A taped replay of the conference call will be available two
hours after the live conference call and will be accessible until
Monday, December 28, 2015 by calling
1 (855) 859-2056 or (416) 849-0833, reference number 14128725.
A live audio webcast of the conference call will be available
through www.nuvoresearch.com. Please connect at least 15 minutes
prior to the conference call to ensure adequate time for any
software download that may be required to hear the webcast.
About Nuvo Research Inc.
Nuvo (TSX:NRI) is a life sciences company with a diverse
portfolio of products and technologies. On September 15, 2015, Nuvo announced that it plans
to split Nuvo into two separate, publicly traded companies.
Under the proposed plan, one company, to be known as Nuvo
Pharmaceuticals Inc. (Nuvo Pharma), will be a commercial healthcare
company that will own the Company's Pennsaid and Pennsaid 2%
franchises and related assets and is expected to generate revenue
and positive earnings. The other company, to be known as
Crescita Therapeutics Inc. (Crescita), will be a development
company that will own the Company's existing drug development
business including its pipeline of product candidates. The
companies will be distinct and separately traded public companies.
Nuvo shareholders will receive shares of both companies.
Complete details of the proposed transaction will be set
forth in information circular that will be mailed to Nuvo's
shareholders in Q1 2016 in connection with a special meeting that
will be called by Nuvo to approve the proposed transaction.
Completion of the proposed transaction is subject to certain
conditions, including final approval by the Nuvo Board of
Directors, confirmation of the potential tax-free nature of the
transaction for Canadian shareholders, regulatory approval
requirements and the approval of Nuvo's shareholders. If
approved by shareholders, Nuvo expects the proposed transaction
would be completed in Q1 2016 (subject to the satisfaction of all
conditions). However, there can be no assurances regarding
the ultimate timing of the proposed transaction or that the
proposed transaction will be completed. For additional company
information visit www.nuvoresearch.com.
Forward-Looking Statements
Certain statements in this press release constitute
forward-looking information and/or forward-looking statements
(collectively, "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, plans
for and timing of the potential development of the Company's
product candidates, the proposed reorganization of the Company into
two separate publicly-traded companies, 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
"may", "will", "proposed", "expect", "intend", "believe", "should"
or "plans", 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, but are not limited to, general
business and economic uncertainties and adverse market conditions;
uncertainties that may delay or negatively impact the proposed
reorganization or cause the proposed reorganization to not occur,
including the failure to obtain any required approvals; 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.
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.