MISSISSAUGA, ON, Dec. 22, 2014 /CNW/ - Nuvo Research Inc. (TSX: NRI), a specialty pharmaceutical company with a diverse portfolio of immunology and topical products, today announced that the United States Patent and Trademark Office (USPTO) has granted U.S. Patent No. 8,911,797, relating to the use of formulations that include chlorite ions (such as WF10) to treat or inhibit allergy-like symptoms that include conjunctivitis in patients suffering from or at risk of developing allergic asthma, allergic rhinitis or atopic dermatitis. This is the Company's third issued U.S. patent that relates to the treatment of allergic asthma, allergic rhinitis and atopic dermatitis with WF10. The patent will expire in 2028.
"We are pleased that we have been able to secure additional U.S. patent protection for WF10 in the field of allergic rhinitis," said Dr. Henrich Guntermann, Nuvo's President, Europe & Immunology Group. "We are eagerly awaiting results from our 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 patient treatment and monitoring phase of the study has now been completed and we expect to release top-line study results in mid-February of 2015."
About the Ongoing WF10 Phase 2 Clinical Trial
179 patients have completed the patient treatment and monitoring phase of 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 WF10 proof-of-concept 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.
About Allergic Conjunctivitis
Allergic conjunctivitis is inflammation of the conjunctiva (the membrane covering the white part of the eye) due to a variety of allergens which differ among patients. Symptoms consist of redness (mainly due to vasodilation of the peripheral small blood vessels), oedema (swelling) of the conjunctiva, itching and increased lacrimation (production of tears). If this is combined with rhinitis, the condition is termed "allergic rhino conjunctivitis". The symptoms are due to release of histamine and other active substances by mast cells, which stimulate dilation of blood vessels, irritate nerve endings, and increase secretion of tears.
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.
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.
Certain statements in this press 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 sale of Pennsaid 2% U.S. rights to Horizon Pharma plc, the litigation settlement with Mallinckrodt Inc. and from the March 2014 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.
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