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The randomized, double-blind, placebo-controlled, single-centre trial will assess the efficacy and safety of WF10 infusions for the treatment of patients with severe persistent allergic rhinitis. The trial will enroll 50 patients who have at least a two-year history of persistent allergic rhinitis, and who have a positive allergen skin test. The trial's primary endpoint will be the change from patient baseline to final Total Nasal Symptom Score, an established scale to measure the aggregation of symptoms consistent in allergic rhinitis. Furthermore, patients will undergo rhinometric examinations and spirometric tests at baseline and during the assessment period to further evaluate WF10's efficacy.
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At the first treatment visit, patients who meet the inclusion and exclusion criteria will be randomized into one of two treatment groups: WF10, or placebo. Treatment will be administered once daily for five consecutive days. Patients will be assessed over a three-month period. Nuvo intends to complete the trial in late 2010 or early 2011.
"Positive Phase 2 data from this trial would substantiate WF10 as an important therapeutic asset," said Dr. Henrich Guntermann, President, Europe and Immunology Group. "We are hopeful that this carefully designed and well controlled clinical study will provide us with the scientific evidence to confirm our long-held belief that WF10 can effectively treat patients with certain autoimmune conditions, such as severe allergic rhinitis."
As previously disclosed, Nuvo is co-developing WF10 as a treatment for allergic rhinitis with the Fraunhofer Institute for Cell Therapy and Immunology IZI in Leipzig, Germany. The Development Bank of Saxony in Germany is providing financial support for this co-operative project that will be conducted in Germany through Nuvo Research GmbH, a Nuvo subsidiary.
Allergic rhinitis, also known as Hay Fever, causes cold-like symptoms such as a runny nose, congestion and sneezing. Unlike a cold, allergic rhinitis isn't 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.
About WF10
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 to 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 currently sold in Canada and several European countries. Pennsaid was approved for marketing in the U.S. by the FDA on November 4, 2009. The commercial launch of Pennsaid in the U.S. by Nuvo's licensee, Covidien (NYSE:COV), is scheduled for the second quarter of 2010. Nuvo intends to leverage its skin-penetrating technologies to create a portfolio of topical and transdermal products targeting a variety of indications. Nuvo is a publicly traded, Canadian pharmaceutical company headquartered in Mississauga, Ontario, with manufacturing facilities in Varennes, Quebec and Wanzleben, Germany, and research and development centers in San Diego, California and Leipzig, Germany. For more information, please visit www.nuvoresearch.com.
Forward-Looking Statements
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
SOURCE Nuvo Research Inc.
