Nuvo Research commences enrollment in WF10 Phase 2 clinical trial for allergic rhinitis

NUVO RESEARCH INC.Mar 16 2010

Nuvo Research Inc. (TSX: NRI), a Canadian drug development company focused on the research and development of drug products that are 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, today announced that it has enrolled the first patient in its European Phase 2 clinical trial evaluating WF10 as a treatment for allergic rhinitis.

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.

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.