Nuvo Research® Reports Topline Results of Phase 2 Trial of WF10™ for the Treatment of Allergic Rhinitis
December 21, 2015
- Study fails to demonstrate separation between WF10 and placebo -
- Company will discontinue development of WF10 and focus on other pipeline products -
- Nuvo to Host Conference Call/Webcast at 8:30 a.m. ET Today -
MISSISSAUGA, ON, Dec. 21, 2015 /CNW/ - Nuvo Research Inc. (TSX:NRI), a life sciences company with growing revenues and a diverse portfolio of topical products, today announced the results of its investigational Phase 2 clinical trial of WF10 (Trial) for the treatment of allergic rhinitis.
Study Results and Company Strategy
Patients dosed with WF10 did not report a reduction in symptoms that was significantly better than patients dosed with a saline placebo at any of the endpoints being measured in the study. There was no significant difference in the performance of WF10 relative to placebo when patients were exposed to grass and ragweed pollen in the Environmental Exposure Chamber (EEC) or when they were exposed to naturally occurring allergens during the field portion of the study.
The Company believes that the results are not sufficient to justify the further development of WF10 for the treatment of allergic rhinitis and plans to discontinue all WF10 development. The Company has a strong balance sheet and these results do not affect the Company's previously announced plans to split Nuvo into two separate, publicly traded companies. Under the proposed plan, one company, to be known as Nuvo Pharmaceuticals Inc. (Nuvo Pharma), will be a commercial healthcare company that will own the Company's Pennsaid and Pennsaid 2% franchises and related assets, and is expected to generate revenue, positive EBITDA and positive net earnings. The other company, to be known as Crescita Therapeutics Inc. (Crescita), will be a drug development company that will own the Company's existing drug development business, including the topical product candidates Flexicaine for the treatment of diabetic peripheral neuropathy, IBUFOAM for the treatment of acute and chronic pain and Onychomycosis Solution for the treatment of onychomycosis, all of which target sizeable market opportunities. Nuvo's shareholders will own 100% of both companies at the time of the split.
"The results of this study make it clear that we should focus our R&D resources on advancing our very promising topical product candidates rather than WF10," said Dan Chicoine, Nuvo's Chairman and Co-CEO. "We have developed specific strategies and are refining development timelines for the advancement of each of these product candidate and plan to finalize and outline the details in Q1 2016."
About the Trial
The Trial commenced enrolment of patients with moderate to severe allergy to grass and ragweed pollen in June of this year. The Trial was a randomized, double-blind, placebo-controlled, single-centre trial to assess the efficacy, safety and tolerability of a regimen of five WF10 infusions. A total of 72 patients completed the Trial. Patients' symptoms were recorded prior to commencement of the grass allergy season in an EEC and symptoms were recorded in the field throughout the grass and ragweed allergy seasons and again in the EEC after completion of the ragweed season. The Trial was 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.
Flexicaine is a proprietary patent-protected cream formulation of lidocaine and tetracaine that is designed for the topical treatment of pain conditions such as post herpetic neuralgia or diabetic peripheral neuropathy. The formulation dries to form a film which can be easily peeled from the skin once actives have been delivered to the site of pain providing a long-lasting anesthetic effect and simple removal of the product.
IBUFOAM targets the treatment of acute and chronic pain conditions such as sprains and strains and osteoarthritis. IBUFOAM is a topical ibuprofen foam formulation that combines the transdermal carrier DMSO, pioneered in Nuvo's Pennsaid products, with 5% of the NSAID ibuprofen and delivers the active drug through the skin directly to the site of inflammation and pain. This product is protected by a patent recently granted by the US Patent and Trademark Office (USPTO).
About Onychomycosis Solution
Onychomycosis Solution is a 10% terbinafine solution developed for topical treatment of onychomycosis, a fungal infection of the nail which is reported to be prevalent in up to 14% of the population in North America. This pipeline candidate is protected by a patent recently granted by the USPTO.
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. The CRO 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 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.
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.
Management to Host Conference Call/Webcast
Management will host a conference call to discuss the results from the WF10 Phase 2 trial today (December 21, 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 14128725. 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 Monday, December 28, 2015 by calling 1 (855) 859-2056 or (416) 849-0833, reference number 14128725.
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 life sciences company with a diverse portfolio of products and technologies. On September 15, 2015, Nuvo announced that it plans to split Nuvo into two separate, publicly traded companies. Under the proposed plan, one company, to be known as Nuvo Pharmaceuticals Inc. (Nuvo Pharma), will be a commercial healthcare company that will own the Company's Pennsaid and Pennsaid 2% franchises and related assets and is expected to generate revenue and positive earnings. The other company, to be known as Crescita Therapeutics Inc. (Crescita), will be a development company that will own the Company's existing drug development business including its pipeline of product candidates. The companies will be distinct and separately traded public companies. Nuvo shareholders will receive shares of both companies. Complete details of the proposed transaction will be set forth in information circular that will be mailed to Nuvo's shareholders in Q1 2016 in connection with a special meeting that will be called by Nuvo to approve the proposed transaction. Completion of the proposed transaction is subject to certain conditions, including final approval by the Nuvo Board of Directors, confirmation of the potential tax-free nature of the transaction for Canadian shareholders, regulatory approval requirements and the approval of Nuvo's shareholders. If approved by shareholders, Nuvo expects the proposed transaction would be completed in Q1 2016 (subject to the satisfaction of all conditions). However, there can be no assurances regarding the ultimate timing of the proposed transaction or that the proposed transaction will be completed. For additional company information visit www.nuvoresearch.com.
Certain statements in this press release constitute forward-looking information and/or forward-looking statements (collectively, "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, plans for and timing of the potential development of the Company's product candidates, the proposed reorganization of the Company into two separate publicly-traded companies, 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 "may", "will", "proposed", "expect", "intend", "believe", "should" or "plans", 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, but are not limited to, general business and economic uncertainties and adverse market conditions; uncertainties that may delay or negatively impact the proposed reorganization or cause the proposed reorganization to not occur, including the failure to obtain any required approvals; 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. 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.
For further information: Investor Relations, Email: [email protected]