VentiRx Pharmaceuticals, Inc., a biopharmaceutical company focused on the development of novel Toll-Like Receptor 8 (TLR8) agonists and antagonists for the treatment of cancer, respiratory and autoimmune diseases, announced today the presentation of positive clinical results from its randomized, placebo-controlled clinical trial evaluating VTX-1463 for the treatment of allergic rhinitis. The results demonstrated statistically significant improvements in allergy symptoms in patients treated with VTX-1463 compared to placebo. The results were presented today in a poster entitled "Intranasal Toll-Like Receptor 8 Agonist (VTX-1463) Significantly Improves Symptoms of Allergic Rhinitis in a Randomized, Placebo-Controlled Trial" at the American Academy of Allergy Asthma & Immunology (AAAAI) 2011 Annual Meeting.
"These results emphasize the potential for VTX-1463 to be an effective means to control seasonal allergies that have negative impacts on patients' quality of life," said Friedrich Horak, M.D., Professor of the Medical University Vienna and Vienna Challenge Chamber (VCC) in Vienna, Austria, and principal investigator of this study. "With an intranasal administration that could be dosed once weekly, VTX-1463 could offer important advantages for patients over currently availably allergy therapies."
The clinical trial assessed safety and efficacy of VTX-1463 in a randomized, placebo-controlled study in 80 patients with confirmed allergy to grass pollen at the VCC. The patients were divided into two dosing regimens or received placebo. Group A received ascending doses of 25, 50, 75 and 100 micrograms once weekly for four weeks. Group B received once weekly administrations of 62.5 micrograms for four weeks. Patients underwent grass pollen exposure at the VCC on Day 24.
Both treatment groups demonstrated statistically significant improvement in the primary endpoint: allergy symptoms based on Total Nasal Symptoms Scores (TNSS), a sum of scores for nasal congestion, itching, sneezing and rhinorrhea, compared to placebo>
"We are gratified to see clearly positive data with VTX-1463 in allergic rhinitis patients," said Robert Hershberg, M.D., Ph.D., Co-founder and Chief Medical Officer at VentiRx. "These data provide important clinical validation for TLR8 as a therapeutic target in humans and help to build a foundation to advance VTX-1463 clinically."
In addition, the company announced a late-breaking oral presentation on March 22, 2011 entitled "VTX-378, A Novel TLR8 Agonist, Attenuates Nasal Congestion after Ragweed Challenge in Sensitized Beagle Dogs" which further substantiates the role of TLR8 agonists pre-clinically in an established dog model of allergic rhinitis.
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