NUVO RESEARCH ANNOUNCES POSITIVE TOP-LINE WF10 PHASE 2 TRIAL RESULTS
November 8, 2010
European Phase 2 Clinical Trial Evaluating WF10 as a Treatment for Severe Allergic Rhinitis Meets its Primary Endpoint
MISSISSAUGA, ON, Nov. 8 /CNW/ - Nuvo Research Inc. (TSX: NRI), a specialty pharmaceutical company focused on the research and development of drug products that are delivered into and through the skin using its topical and transdermal drug delivery technologies and on the development of its immune modulating drug candidate WF10, today announced that its European Phase 2 clinical trial evaluating WF10 as a treatment for severe allergic rhinitis met its primary endpoint.
"These top-line results support our view that WF10 has the potential to become an effective treatment for patients with certain autoimmune conditions, such as severe allergic rhinitis," said Henrich Guntermann, President, Europe & Immunology Group for Nuvo Research. "We will evaluate the entire data set when it is available and consult with our advisors to determine the optimal path forward to maximize the value of WF10 for Nuvo and its shareholders."
The randomized, double-blind, placebo-controlled, single-centre trial assessed the efficacy and safety of WF10 infusions for the treatment of patients with severe persistent allergic rhinitis. The trial enrolled 60 patients who have at least a two-year history of persistent allergic rhinitis and who had a positive allergen skin test.
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 TNSS is a validated scale to measure the aggregation of nasal symptoms associated with allergic rhinitis. The p-value for the primary endpoint was less than 0.001 for the intent-to-treat and per protocol groups.
No significant adverse events were observed during the trial, which was conducted at a clinic site that specializes in airway diseases in Leipzig, Germany.
About Allergic Rhinitis
Allergic rhinitis, also known as hay fever, causes cold-like symptoms such as a runny nose, congestion and sneezing. Unlike a cold, allergic rhinitis is not caused by a virus; it is caused by an allergic response to airborne allergens such as pollen, pet dander or dust mites. The condition affects about one in five people according to the Mayo Clinic.
Severe allergic rhinitis is a more severe form of the condition and often does not respond well to conventional treatments. Also, chronic treatment with conventional drugs, e.g. corticosteroids, often causes significant side effects.
Bank of Saxony
The Development Bank of Saxony in Germany is providing financial support for this project that is being conducted in Germany through Nuvo Research GmbH, a Nuvo subsidiary.
The immune system provides an essential defense to micro organisms, cancer and substances it sees as foreign and potentially harmful. WF10 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. 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.
About Nuvo Research Inc.
Nuvo is primarily focused on the research and development of drug products delivered into and through the skin using its topical and transdermal drug delivery technologies, and on the development of its immune modulating drug candidate WF10. Nuvo's lead product is Pennsaid, a topical non-steroidal anti-inflammatory drug (NSAID), which is sold in Canada, the United States and several European countries. Pennsaid was approved for marketing in the U.S. by the United States Food and Drug Administration on November 4, 2009 and is being sold throughout the United States by Nuvo's licensing partner, Mallinckrodt Inc., a Covidien (NYSE: COV) company. Nuvo intends to create a portfolio of products through internal research and development and by in-licensing and acquisition. Nuvo is a publicly traded, Canadian pharmaceutical company headquartered in Mississauga, Ontario. Nuvo's Pain Group is located in West Chester, Pennsylvania. Its manufacturing facilities are located in Varennes, Québec and Wanzleben, Germany, and its research and development centers are located in San Diego, California and Leipzig, Germany. For more information, please visit www.nuvoresearch.com
This document contains forward-looking statements. Some forward-looking statements may be identified by words like "expects", "anticipates", "plans", "intends", "indicates" or similar expressions. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Nuvo considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared, but caution that these assumptions regarding future events, many of which are beyond the control of the Company, may ultimately prove to be incorrect. Factors and risks, which could cause actual results to differ materially from current expectations, are discussed in the annual report, as well as in Nuvo's Annual Information Form for the year ended December 31, 2009. Nuvo disclaims any intention or obligation to update or revise any forward-looking statements whether a result of new information or future events, except as required by law. For additional information on risks and uncertainties relating to these forward looking statements, investors should consult the Company's ongoing quarterly filings, annual report and Annual Information Form and other filings found on SEDAR at www.sedar.com
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