Nuvo Research® Receives Health Canada Approval to Conduct New WF10™ Phase 2 Trial
MISSISSAUGA, ON, June 8, 2015 /PRNewswire/ - Nuvo Research Inc. (TSX:NRI), a specialty pharmaceutical company with a diverse portfolio of topical and immunology products, today announced it has received Health Canada approval to conduct a new Phase 2 clinical trial (the 2015 WF10 Trial) to assess WF10 for the treatment of allergic rhinitis.
The 2015 WF10 Trial will commence this month. It will be a randomized, double-blind, placebo-controlled, single-center trial to assess the efficacy, safety and tolerability of a regimen of five WF10 infusions. The trial will enroll patients who have a moderate to severe allergy to grass and ragweed pollen and will build on learnings derived from previous WF10 allergic rhinitis studies run in 2010 and 2014 (the 2010 WF10 Trial and 2014 WF10 Trial, respectively). Patients' symptoms have already been recorded prior to commencement of the 2015 WF10 Trial in an Environmental Exposure Chamber (EEC), and will be recorded in the field during the grass and ragweed allergy seasons and again in the EEC after completion of the ragweed season. The 2015 WF10 Trial is expected to enroll approximately 146 patients and to be completed with topline results available in late Q4 2015 or early Q1 2016. The trial will be conducted in southern Ontario, Canada by Inflamax Research Inc. (Inflamax), a full service, specialty Contract Research Organization (CRO) that specializes in allergy, respiratory and EEC studies. Nuvo's external costs of conducting the trial will be approximately CDN$5.0 million.
"We are excited to get this critical trial underway," said Dr. Henrich Guntermann, President, Europe & Immunology Group. "The design of the new study includes a number of features that differentiate it from our inconclusive 2014 WF10 Trial to enhance the chance of a successful outcome including (i) enrollment of larger numbers of patients per arm (ii) the use of an EEC to fully-characterize patients prior to entry into the study, (iii) a tight enrollment window to ensure consistent patient exposure to allergens and (iv) the use of electronic diaries to capture daily symptom scores. We are optimistic that by the end of this year or early 2016, we will have positive trial results that will support the further development of WF10."
If the 2015 WF10 Trial is successful, the Company plans to continue WF10 development in an independently financed entity that will include the participation of Nuvo shareholders. While Nuvo's management is optimistic that the 2015 WF10 Trial will generate positive results, should the trial be unsuccessful, the Company plans to discontinue WF10 development. The Company has taken steps to curtail spending on a number of WF10 projects and studies planned for 2015 until results of the 2015 WF10 Trial are available.
About Inflamax Research Inc.
Headquartered in Toronto, Ontario, Inflamax is a full service, global CRO specializing in Proof of Concept, and Phase I through to Phase IV studies in allergy, asthma, ocular, healthy volunteer studies and dermatology. Inflamax Research is a world leader in conduct and design of single and multi-center EEC and field allergy studies. Inflamax has developed the supporting proprietary clinical tools such as ePRO, ePDAT™, to improve data collection and quality, and OCRUP™ for successful patient recruitment.
About Environmental Exposure Chambers
Inflamax's Environmental Exposure Chambers (EEC) are facilities that are validated to tightly regulate temperature and humidity while simulating the level of allergen exposure patients would encounter in their everyday lives. By monitoring patients throughout the exposure, nasal, bronchial and ocular symptoms and signs may be evoked consistently and safely.
About WF10
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 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 the WF10 Trial conducted in 2014 (the 2014 WF10 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 trial 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. As anticipated, the WF10 arm reduced allergy symptoms as evidenced by recorded patient Total Nasal Symptom Scores (TNSS) and Total Ocular Symptom Scores (TOSS). The placebo arm demonstrated an unexpectedly large reduction in patient TNSS and TOSS scores that was greater than those observed in the placebo arm in the Company's 2010 Phase 2 Proof-of-Concept clinical trial (the 2010 Trial). Moreover, in contrast to the 2010 Trial, TNSS and TOSS scores in the placebo arm declined at each successive time point in the 2014 Trial with no tendency to revert towards baseline over time. While the WF10 arm and the two separate arms that included constituent elements of WF10 all performed better than the placebo arm, the differences were not statistically significant. The Company believes that the placebo group in the 2014 Trial did not record as high TNSS and TOSS scores compared to the 2010 Trial due to a longer enrollment period that started later in the allergy season, varying environmental conditions and other factors that resulted in some patients in the 2014 Trial not being exposed to a high enough concentration of the allergens that they were allergic to throughout the trial period.
About the WF10 Trial conducted in 2010 (the 2010 WF10 Trial)
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 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 currently has four commercial products, a pipeline of topical and transdermal products focusing on pain and dermatology and multiple 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 and an immune system modulation platform that supports the development of drug products that modulate chronic inflammation processes resulting in a therapeutic benefit. For additional company information visit www.nuvoresearch.com.
Forward-Looking Statements
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 statements concerning the Company's future objectives, strategies to achieve those objectives, as well as statements with respect to management's beliefs, plans, estimates, and intentions, 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 19, 2015 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 press 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 press release are qualified by these cautionary statements. The forward-looking statements contained herein are made as of the date of this press 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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