Nuvo Research® Completes Enrolment in WF10™ Phase 2 Clinical Trial
September 3, 2014
- Results Expected Q1 2015 -
MISSISSAUGA, ON, Sept. 3, 2014 /CNW/ - Nuvo Research Inc. (TSX:NRI), a specialty pharmaceutical company with a diverse portfolio of topical and immunology products, today announced that it has completed enrolment in its Phase 2 clinical trial to investigate the safety and efficacy of WF10 in patients with refractory allergic rhinitis. The Company expects the trial to be completed in late 2014 with top-line results anticipated in the first quarter of 2015.
"This study's goal is to expand upon the successful results attained with WF10 in our first Phase 2 allergic rhinitis study. In that study we saw a statistically significant reduction in allergy scores for patients treated with WF10 as compared to placebo," said Henrich Guntermann, President, Europe & Immunology Group. "Having now completed enrolment in our second larger multi-center Phase 2 study, we move closer to generating further evidence of WF10's potential benefit for allergy sufferers whose disease is not adequately controlled with existing therapies."
WF10 Phase 2 Clinical Trial
Treatment of patients in the WF10 Phase 2 allergic rhinitis clinical trial commenced in March 2014. The trial is fully enrolled at 15 sites in Germany. Enrolment was slowed by weather conditions in the second quarter of 2014 resulting in a decreased exposure of patients to pollens and lower incidence of allergic rhinitis symptoms. 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 with multiple airborne allergies who suffer from moderate to severe allergic rhinitis. The trial will measure total nasal symptom score (TNSS) and other secondary endpoints. The trial is designed to confirm the results of the Company's 2010 Phase 2 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).
Allergic Rhinitis and Refractory 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 a strong degree of symptom incidence and do not respond adequately to common forms of treatment. 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.
The immune system provides an essential defense to microorganisms, cancer and substances it sees as foreign and potentially harmful. In conditions such as allergic rhinitis, the body's immune system inappropriately responds to the presence of foreign allergens. Research suggests that in some cases, WF10 may rebalance improperly functioning immune systems. WF10 is an infusion therapy currently approved only in Thailand under the name IMMUNOKINE for the treatment of post-radiation-therapy syndromes and diabetic foot ulcers. WF10 is not yet approved for the treatment of moderate to severe allergic rhinitis.
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.
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SOURCE Nuvo Research Inc.
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