Nuvo Research® Completes WF10™ U.S. Market Study for Treatment of Refractory Allergies
October 22, 2014
MISSISSAUGA, ON, Oct. 22, 2014 /CNW/ - 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.
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.
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SOURCE Nuvo Research Inc.
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