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- Results Expected Q1 2015 -
MISSISSAUGA, ON, Sept. 3, 2014 /PRNewswire/ - 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.
Certain statements in this news release constitute forward-looking statements within the meaning of applicable securities laws. Forward-looking statements include, but are not limited to the Company's anticipated use of proceeds from the Private Placement, the Company's future share price and the Company's possible election to accelerate the expiry date of any of the warrants or the brokers warrants 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 "outlook", "objective", "may", "will", "expect", "intend", "estimate", "anticipate", "believe", "should", "plans" or "continue", 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 general business and economic uncertainties and adverse market conditions as well as other risk factors included in the Company's Annual Information Form dated February 20, 2014 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. The factors underlying current expectations are dynamic and subject to change. Although the forward-looking information contained in this news 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 news release are qualified by these cautionary statements. The forward-looking statements contained herein are made as of the date of this news 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.