Mississauga, Ontario, Canada – January 30, 2015 – Nuvo Research Inc. (TSX:NRI), a specialty pharmaceutical company with a diverse portfolio of topical and immunology products, today announced the results of its 16-week, double-blind, placebo-controlled, Phase 2 clinical trial conducted in Germany to compare the safety and efficacy of WF10 and its main constituents (sodium chlorite and sodium chlorate) with saline in patients with refractory allergic rhinitis and to compare the safety and efficacy of WF10 and its main constituents. The study included three active arms (the Active Arms): a) WF10; b) WF10 with chlorate and sulphate removed; and c) WF10 with chlorite and sulphate removed. Each of the Active Arms was compared to a placebo arm in which patients received saline. Active or placebo treatments were administered by five intravenous infusions given once per day during the first five days of the study. The primary endpoint was change in Total Nasal Symptom Score (TNSS) from baseline to assessment after three weeks. TNSS is a validated scale to measure nasal symptoms associated with allergic rhinitis.
Topline Findings of the Study are:
• The WF10 arm demonstrated a reduction in TNSS over the course of the observation period similar to the reduction in TNSS demonstrated in the WF10 arm in the Company’s previous 2010 Phase 2 proof-of-concept study described further below.
• The placebo arm demonstrated a reduction in TNSS over the course of the observation period that was significantly greater than demonstrated in the placebo arm of the Company’s 2010 Phase 2 proof-of-concept study.
• Each of the Active Arms demonstrated a greater reduction in TNSS than placebo; however, (i) the difference between the WF10 arm and the placebo arm did not achieve statistical significance 3 weeks after commencement of the study which was the study’s primary endpoint and (ii) the difference between the Active Arms and the placebo arm did not achieve statistical significance at measured time points over the course of the observation period.
• Treatments administered in the Active Arms were well tolerated with favourable safety profiles.
The Company is conducting a detailed review of the data and expects to release further information and analysis of the data including information on secondary endpoints in the coming weeks.
“While the WF10 arm performed as expected, the placebo arm demonstrated a much greater than anticipated reduction in allergy symptom scores,” said Dr. Henrich Guntermann, President, Europe & Immunology Group. “The cold and wet allergy season in Germany may have reduced symptoms for all patients in the study and possibly impacted the difference in symptoms between the WF10 arm and the placebo arm. We are conducting a more detailed analysis of the data which we will report when it becomes available.”
About the WF10 Phase 2 Clinical Trial
184 patients were enrolled in and 179 patients completed the WF10 Phase 2 allergic rhinitis clinical trial that commenced in March 2014 at 15 sites in Germany. The 16-week trial was 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 who suffer from refractory allergic rhinitis with positive skin test to at least one allergen. 46 patients were enrolled in each of 4 arms to receive WF10, WF10 with chlorate removed, WF10 with chlorite removed or placebo (saline). The trial measured total nasal symptom score (TNSS), total ocular symptom score (TOSS) and other secondary endpoints. The trial was designed to confirm the results of the Company’s 2010 Phase 2 WF10 proof-of-concept clinical trial for the treatment of allergic rhinitis with WF10 which achieved statistical significance (P<0.001) for its primary endpoint (change in TNSS at week 3). It was 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 syndromes and adjunctive therapy of diabetic foot ulcers.
Management to Host Conference Call/Webcast
Management will host a conference call to discuss the results from the WF10 Phase 2 trial today (January 30, 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 78033834. 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 Friday, February 6, 2015 by calling 1 (855) 859-2056 or (416) 849-0833, reference number 78033834.
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 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 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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