Nuvo Research® reports that all patients have completed Phase 2 study of WF10™ for the treatment of allergic rhinitis
December 18, 2014
- Top-Line Results Expected in February 2015 -
MISSISSAUGA, ON, Dec. 18, 2014 /CNW/ - Nuvo Research Inc. (TSX:NRI), a specialty pharmaceutical company with a diverse portfolio of immunology and topical products, today announced that 179 patients have completed its 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 Company expects to release the top-line results of the study in mid-February of 2015.
"We are excited to have completed the 16-week patient treatment and monitoring phase of the study and we expect to release top-line results in mid-February 2015," said Dr. Henrich Guntermann, President, Europe & Immunology Group. "One of the main purposes of the study is to validate the results of our 60-patient Phase 2 proof-of-concept study conducted in 2010. Patients in that study and in independent case studies have reported that a single 5-day course of treatment with WF10 could provide 1 to 2 years of symptomatic relief from multiple air-borne allergens. These unique attributes make WF10 a revolutionary product candidate for patients who don't obtain adequate relief from standard allergy treatments such as antihistamines and inhaled corticosteroids."
About the Ongoing WF10 Phase 2 Clinical Trial
Over 160 patients have been enrolled in 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 proof-of-concept WF10 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.
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 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.
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SOURCE Nuvo Research Inc.
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