Nuvo Research provides details of new WF10 Phase 2 clinical trial for treatment of allergic rhinitis

NewsGuard 100/100 Score

Nuvo Research Inc. (TSX:NRI), a specialty pharmaceutical company with a diverse portfolio of topical and immunology products, today announced additional details of its new Phase 2 clinical trial (the 2015 WF10 Trial) to assess WF10 for the treatment of allergic rhinitis.

The 2015 WF10 Trial 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. Patients' symptoms will be recorded prior to commencement of the grass allergy season in an Environmental Exposure Chamber (EEC), in the field throughout 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. Commencement of the 2015 WF10 Trial is subject to regulatory approval by Health Canada.

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.

"This is a critical trial to the future of WF10," said Dr. Henrich Guntermann, President, Europe & Immunology Group. "It is designed to increase the likelihood that patients are exposed to sufficient concentrations of allergens to which they are allergic. We believe that a lack of allergen exposure led to inconclusive results in our 2014 Phase 2 clinical trial and we expect that the results of this new trial will more closely compare to the positive results from our 2010 clinical trial."

Comments

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment
Post

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.

You might also like...
Neurological Narratives: A Journey into Women's Brain Health Research